Be Part of Research - Trial Details - Testing if the SonoTran Platform can enhance drug delivery in metastatic colorectal cancer

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Background and study aims
This study will look at a new intervention in patients with bowel cancer that has spread to the liver (called colorectal cancer liver metastases (CRLM)). This is required because bowel cancer is very common, and despite best efforts, once CRLM are present, the chances of cure are small. The planned intervention combines specialist ultrasound treatment delivered to the body through the skin over the liver area (SonoTran System), and the injection of microscopic cup-shaped ‘particles’ (SonoTran Particles) that are given into the vein. The hope is that when these two are delivered together (termed the SonoTran Platform) they will help ‘push’ standard cancer drugs deeper into the tumours and increase the effectiveness of those drugs (both standard chemotherapy drugs, and newer larger cancer antibody drugs). The study is split into three parts. In the first part (cohort 1) patients who have received all standard drugs for their bowel cancer, or who are having a break off standard drugs, will receive one ‘treatment’ with the specialist ultrasound (called SonoTran System-SS) and one injection of the SonoTran Particles(SP), in order to assess the safety of the new intervention. In Cohort 2, patients who are about to have their CRLMs removed by surgery will, on the day before, receive one low dose each of the anticancer drugs irinotecan and cetuximab and, in addition, half of the patients will receive an injection of SonoTran Particles and a single 'treatment' with SonoTran ultrasound. The tumours (CRLMs) that are removed will be examined to see how much and how deep the drugs get into them. In Cohort 3, patients who have not yet received treatment for their CRLMs will receive repeated cycles of standard chemotherapy drugs (5-fluoruracil, irinotecan and cetuximab) and half of them will also receive SonoTran particles and SonoTran Ultrasound. Tumour responses will be measured and compared.

For Cohort 1 (Safety), the researchers are looking at the safety of the SonoTran Platform intervention alone (ultrasound and particles), and no anticancer drugs will be given. During the SonoTran ‘intervention’ phase, patients will receive a long injection (called an infusion) of SonoTran Particles, and an administration of therapeutic SonoTran ultrasound using the SonoTran System. Additional blood samples will be taken for research tests on Day 1; the first sample will be taken immediately before patients receive the SonoTran Particles, and then at set timepoints after the start of the infusion - 15 minutes, 30 minutes, 45 minutes and 60 minutes. Patients will then be asked to return for a follow-up visit on weekly intervals - Day 8, Day 15 and Day 22 after the intervention and receive a physical examination, be asked about symptoms and any other medications, have weight, heart rate, temperature, pulse and blood pressure checked, and have routine blood tests. About 4 weeks after receiving the SonoTran Platform intervention, patients will have an FDG-PET-CT scan, an MRI scan and a CT scan to assess their tumour(s) and the effect of the SonoTran Platform.
In Cohort 2 (Performance), the researchers will investigate whether the SonoTran Platform (the combination of the SonoTran System and SonoTran Particles) can increase the delivery of a couple of routine anticancer drugs to the tumour. To do this the researchers will recruit 6 patients who, the day before their liver operation, will receive two anticancer drugs alone - cetuximab and irinotecan (at lower than standard doses), and another 6 who will receive the same anticancer drugs plus the SonoTran Platform intervention; and the researchers will compare how much of the drugs get into the tumour and how deep they get into the tumour. The researchers will be taking some of the tumour and normal tissue that is taken from the liver at your operation and they will look at the drug levels in the normal and tumour tissue in the liver. Once patients have received the intervention (drugs alone or drugs plus SonoTran Platform intervention), on Day 1, they will return the following day (Day 2) to have their tumour nodule(s) surgically removed from their liver; patients will undergo this procedure as they normally would in standard of care, and taking part in this study will not affect or delay the surgery. Additional blood samples will be taken for research tests on Day 1 and Day 2. Patients will then be asked to return for a follow-up visit on weekly intervals - Day 8, Day 15, Day 22 and on Day 29 (+/- 3 days) after the intervention and receive a physical examination, be asked about symptoms and any other medications, have weight, heart rate, temperature, pulse and blood pressure checked, and have routine blood tests.
Cohort 3 (Efficacy) will make a comparison of response between the two groups of patients; 12 patients will receive the administration of the SonoTran Particles and SonoTran System in addition to the anticancer drugs, and another 12 patients will receive the chemotherapy without the addition of the SonoTran Platform. All patients in Cohort 3 (Efficacy) will receive anticancer drugs that are used routinely in the treatment of metastatic colorectal cancer (mCRC) i.e. cancer that has spread elsewhere outside the bowel. This treatment involves a drug called cetuximab, which is an antibody treatment that blocks a growth factor receptor on tumour cells to help stop them from growing. Patients will also receive two chemotherapy drugs which are called irinotecan and 5-fluorouracil (5FU). The combination of these drugs is called FOLFIRI. During the ‘intervention’ phase of your study involvement, participants will attend the hospital to receive six cycles of this routine cetuximab and FOLFIRI, which will be given at standard doses, every 2 weeks for a 10-week period (six cycles in all). All patients will have a CT scan, MRI scan and PET-CT scan after three ‘cycles’ of anticancer treatment, to assess their tumour and the effect of the drugs (+/- the SonoTran Platform). These scans will be repeated after six cycles of anticancer agents, or sooner if the patient has to come off trial treatment for any other reason. For patients who are receiving chemotherapy drugs AND the SonoTran intervention, additional blood samples will be taken for research tests on every visit they receive intervention – Day 1, Day 15, Day 29, Day 43, Day 57 and Day 71 – one sample will be taken each treatment day about 30 minutes after patients start receiving the SonoTran Particles. Patients will receive a physical examination, be asked about symptoms and any other medications, have their weight, heart rate, temperature, pulse and blood pressure checked, and have routine blood tests at all visits.

Patients diagnosed with colorectal (bowel) cancer that has spread to the liver. Patients must be over 18 years of age and meet the trial’s specific eligibility criteria to participate in the study. For more information, please contact your GP or oncologist

You can take part if:

Current inclusion criteria as of 12/06/2023:
Current participant inclusion criteria as of 12/06/2023:
Cohort 1 (safety):
1. At least 1 confirmed CRC liver metastasis >1cm in diameter that is geographically accessible to SonoTran intervention
2. ≥ 18 years of age.
3. Written (signed and dated) informed consent and be capable of cooperating with treatment and follow-up.
4. Haematological and biochemical indices within the ranges shown below within 14 days prior to enrolment:
4.1. Haemoglobin (Hb) ≥9.0 g/dl (can be transfused to this value)
4.2. Absolute neutrophil count ≥1.5 x 10e9/l
4.3. Platelet count ≥100 x 10e9/l
4.4. Serum bilirubin ≤1.5 x upper limit of normal (ULN)
4.5. Alanine aminotransferase (ALT) ≤5 x ULN
4.6. Aspartate aminotransferase (AST) ≤5 x ULN
4.7. Serum creatinine ≤1.5 x ULN
4.8. PT and APTT ≤1.25 x ULN
4.9 Albumin ≥28 g/l
5. Female subjects of childbearing potential must have negative pregnancy test within 14 days prior to SonoTran intervention.
6. Patients with a diagnosis of mCRC, who are either not eligible to receive the standard of care chemotherapy or who have exhausted all lines of standard of care; or who are presently on a planned break from SOC chemotherapy.
7. ECOG performance status of 0, 1 or 2.

Cohort 2 (performance):
1. At least 1 confirmed CRC liver metastasis >1cm in diameter, and metastatic disease that is planned to be IMMEDIATELY resected is without formal neo-adjuvant chemotherapy.
2. The metastasis(es) can be geographically inaccessible to SonoTran intervention as long as there are still spaces in Cohort 2A of the study (i.e. drugs alone prior to surgical resection). If there are no spaces on Arm 2A and spaces still remain on Arm 2B, the patients will require to have at least one geographically-accessible lesion amenable to SonoTran intervention.
3. Chemotherapy-naïve in terms of chemotherapy for metastatic CRC (patients can have received adjuvant chemotherapy as long as this has been completed at least 3 months prior to planned intervention within the study)
4. If there is disease outside of the liver, there must be a plan to eradicate this e.g. by surgery, ablation or SABR treatment as part of the curative strategy.
5. ≥ 18 years of age.
6. Written (signed and dated) informed consent and be capable of cooperating with treatment and follow-up.
7. Haematological and biochemical indices within the ranges shown below within 14 days prior to enrolment:
7.1. Haemoglobin (Hb) ≥9.0 g/dL (can be transfused to this value)
7.2. Absolute neutrophil count ≥1.5 x 10e9/l
7.3. Platelet count ≥100 x 10e9/L
7.4. Serum bilirubin ≤1.5 x upper limit of normal (ULN)
7.5. Alanine aminotransferase (ALT) ≤5 x ULN
7.6. Aspartate aminotransferase (AST) ≤5 x ULN
7.7. Serum creatinine ≤1.5 x ULN
7.8. PT and APTT ≤1.25 x ULN
7.9. Albumin ≥28g/l
8. Female subjects of childbearing potential must have negative pregnancy test within 14 days prior to SonoTran intervention.
9. ECOG performance status of 0 or 1.
10. Female subjects of childbearing potential and male subjects whose sexual partners are of childbearing potential must agree to abstain from sexual intercourse or to use an effective method of contraception during the study and up to 6 months after the end of study. Examples of effective methods of contraception include oral or injected contraceptives or double barrier methods such as condom plus spermicide or condom plus diaphragm.

Cohort 3 (efficacy):
1. At least 1 confirmed CRC liver metastasis >1cm in diameter, and metastatic disease that is NOT planned to be IMMEDIATELY resected or ablated.
2. Patients will require to have at least one geographically-accessible lesion amenable to SonoTran intervention.
3. Chemotherapy-naïve in terms of chemotherapy for metastatic CRC (patients can have received adjuvant chemotherapy as long as this has been completed at least 3 months prior to planned intervention within the study)
4. ≥ 18 years of age.
5. Written (signed and dated) informed consent and be capable of cooperating with treatment and follow-up.
6. Haematological and biochemical indices within the ranges shown below within 14 days prior to enrolment:
6.1. Haemoglobin (Hb) ≥9.0 g/dL (can be transfused to this value)
6.2. Absolute neutrophil count ≥1.5 x 10e9/L
6.3. Platelet count ≥100 x 10e9/L
6.4. Serum bilirubin ≤1.5 x upper limit of normal (ULN)
6.5. Alanine aminotransferase (ALT) ≤5 x ULN
6.6. Aspartate aminotransferase (AST) ≤5 x ULN
6.7. Serum creatinine ≤1.5 x ULN
6.8. PT and APTT ≤1.25 x ULN
6.9. Albumin ≥28g/l
7. Confirmed RAS wild-type CRC
8. Female subjects of childbearing potential must have negative pregnancy test within 14 days prior to SonoTran intervention.
9. ECOG performance status of 0 or 1.
10. Female subjects of childbearing potential and male subjects whose sexual partners are of childbearing potential must agree to abstain from sexual intercourse or to use an effective method of contraception during the study and up to 6 months after the end of

You may not be able to take part if:

Current participant exclusion criteria as of 12/06/2023:Cohort 1 (safety):1. Any active anti-cancer therapy (chemotherapy / small molecule inhibitors / immunotherapy) within 4 weeks or liver radiotherapy within 8 weeks, prior to planned intervention in the study.2. Persistent, unresolved CTCAE v5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, chronic neuropathy) following previous treatment.3. Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to enrolment.4. Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the clinical investigation or interfere with the interpretation of clinical investigation results.5. Serious/symptomatic active infection or infection requiring antibiotics, within 7 days prior to enrolment.6. Presence of active cholangitis.7. Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy.8. Known bleeding diathesis.9. Inability to comply with the protocol requirements.10. Participation in any other clinical trials involving therapeutic agents within the last 4 weeks prior to enrolment.11. Pregnant or lactating females.12. Patients with liver metastases eligible for immediate surgical resection or other radical therapy such as ablation, unless these interventions are not expected to occur within the next 8 weeks, allowing participation in the study and completion of follow-up, prior to that specified intervention

Cohort 2 (performance):1. Any active anti-cancer therapy (chemotherapy / small molecule inhibitors / immunotherapy) within 4 weeks or liver radiotherapy within 8 weeks, prior to SonoTran intervention.2. Persistent, unresolved CTCAE v5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, chronic neuropathy) following previous treatment.3. Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to enrolment.4. Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the clinical investigation or interfere with the interpretation of clinical investigation results.5. Serious/symptomatic active infection or infection requiring antibiotics, within 7 days prior to enrolment.6. Presence of active cholangitis.7. Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy.8. Known bleeding diathesis.9. Inability to comply with the protocol requirements.10. Participation in any other clinical trials involving therapeutic agents within the last 4 weeks prior to enrolment.11. Pregnant or lactating females.12. Known UGT-1A1 polymorphism.13. Patients with liver metastases that require formal neoadjuvant chemotherapy to downstage prior to resection.14. Patients whose main radical intervention to the liver at outset is planned to be ablation rather than surgery.

Cohort 3 (efficacy):1. Metastatic disease outside of the liver that is reasonably expected to cause acute deterioration or death within 14 weeks of entry into the study i.e. the patient’s life expectancy should be at least 14 weeks in order to allow completion of protocolled intervention and primary endpoint read-out.2. Any active anti-cancer therapy (chemotherapy / small molecule inhibitors / immunotherapy) within 4 weeks or liver radiotherapy within 8 weeks, prior to SonoTran intervention.3. Persistent, unresolved CTCAE v5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, chronic neuropathy) following previous treatment.4. Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to enrolment.5. Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the clinical investigation or interfere with the interpretation of clinical investigation results.6. Serious/symptomatic active infection or infection requiring antibiotics, within 7 days prior to enrolment.7. Presence of active cholangitis.8. Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy.9. Known bleeding diathesis.10. Inability to comply with the protocol requirements.11. Participation in any other clinical trials involving therapeutic agents within the last 4 weeks prior to enrolment.12. Patients with history of QT prolongation, clinically significant VT, VF, heart block, myocardial infarction within 6 months, CHF NYHA Class III or IV, unstable angina.13. Pregnant or lactating females.14. Known DPD deficiency or UGT-1A1 polymorphism.15. Patients with liver metastases that are IMMEDIATELY amenable to surgical resection without neoadjuvant treatment.16. Patients for whom IMMEDIATE ablation is felt to be appropriate.

Previous participant exclusion criteria from 26/04/2023 to 12/06/2023:Cohort 1 (safety):1. Any active anti-cancer therapy (chemotherapy/small molecule inhibitors/immunotherapy) within 4 weeks or liver radiotherapy within 8 weeks, prior to SonoTran intervention2. Persistent, unresolved CTCAE v5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, chronic neuropathy) following previous treatment3. Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to enrolment4. Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the clinical investigation or interfere with the interpretation of clinical investigation results5. Serious/symptomatic active infection or infection requiring antibiotics, within 7 days prior to enrolment6. Disease requiring metal biliary stent(s) (plastic stents allowed)7. Presence of active cholangitis8. Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy9. Known bleeding diathesis10. Inability to comply with the protocol requirements11. Participation in any other clinical trials involving therapeutic agents within the last 4 weeks prior to enrolment12. Patients with history of QT prolongation, clinically significant VT, VF, heart block, myocardial infarction within 6 months, CHF NYHA Class III or IV, unstable angina13. Pregnant or lactating females14. Patients with liver metastases eligible for immediate surgical resection or other radical therapy such as ablation

Cohort 2 (performance):1. Any active anti-cancer therapy (chemotherapy/small molecule inhibitors/immunotherapy) within 4 weeks or liver radiotherapy within 8 weeks, prior to SonoTran intervention2. Persistent, unresolved CTCAE v5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, chronic neuropathy) following previous treatment3. Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to enrolment4. Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the clinical investigation or interfere with the interpretation of clinical investigation results5. Serious/symptomatic active infection or infection requiring antibiotics, within 7 days prior to enrolment6. Presence of active cholangitis7. Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy8. Known bleeding diathesis9. Inability to comply with the protocol requirements10. Participation in any other clinical trials involving therapeutic agents within the last 4 weeks prior to enrolment11. Pregnant or lactating females12. Known UGT-1A1 polymorphism13. Patients with liver metastases that require neoadjuvant chemotherapy to downstage prior to resection14. Patients whose main radical intervention to the liver at outset is planned to be ablation rather than surgery

Cohort 3 (efficacy):See Cohort 2 exclusion criteria with the excluding of criteria 3, and the additional criteria below:1. Known DPD deficiency or UGT-1A1 polymorphism2. Patients with liver metastases that are IMMEDIATELY amenable to surgical resection without neoadjuvant treatment3. Patients for whom IMMEDIATE ablation is felt to be appropriate4. Patients who have metastatic disease outside of the liver that is likely to progress significantly over the next 3 months and limit life expectancy and prevent measurement of the required endpoints of the study in terms of response within the liver

Previous participant exclusion criteria:Cohort 1 (safety):1. Any active anti-cancer therapy (chemotherapy/small molecule inhibitors/immunotherapy) within 4 weeks or liver radiotherapy within 8 weeks, prior to SonoTran intervention2. Persistent, unresolved CTCAE v5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, chronic neuropathy) following previous treatment3. Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to enrolment4. Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the clinical investigation or interfere with the interpretation of clinical investigation results5. Serious/symptomatic active infection or infection requiring antibiotics, within 7 days prior to enrolment6. Disease requiring metal biliary stent(s) (plastic stents allowed)7. Presence of active cholangitis8. Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy9. Known bleeding diathesis10. Inability to comply with the protocol requirements11. Participation in any other clinical trials involving therapeutic agents within the last 4 weeks prior to enrolment12. Patients with history of QT prolongation, clinically significant VT, VF, heart block, myocardial infarction within 6 months, CHF NYHA Class III or IV, unstable angina13. Pregnant or lactating females14. Patients with liver metastases eligible for immediate surgical resection or other radical therapy such as ablation

Cohort 2 (performance):1. Any active anti-cancer therapy (chemotherapy/small molecule inhibitors/immunotherapy) within 4 weeks or liver radiotherapy within 8 weeks, prior to SonoTran intervention2. Persistent, unresolved CTCAE v5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, chronic neuropathy) following previous treatment3. Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to enrolment4. Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the clinical investigation or interfere with the interpretation of clinical investigation results5. Serious/symptomatic active infection or infection requiring antibiotics, within 7 days prior to enrolment6. Disease requiring metal biliary stent(s) (plastic stents allowed)7. Presence of active cholangitis8. Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy9. Known bleeding diathesis10. Inability to comply with the protocol requirements11. Participation in any other clinical trials involving therapeutic agents within the last 4 weeks prior to enrolment12. Patients with a history of QT prolongation, clinically significant VT, VF, heart block, myocardial infarction within 6 months, CHF NYHA Class III or IV, unstable angina13. Pregnant or lactating females14. Known UGT-1A1 polymorphism15. Patients with liver metastases that require neoadjuvant chemotherapy to downstage prior to resection16. Patients whose main radical intervention to the liver at outset is planned to be ablation rather than surgery17. Female subjects of childbearing potential and male subjects whose sexual partners are of childbearing potential must agree to abstain from sexual intercourse or to use an effective method of contraception during the study and up to 6 months after the end of study. Examples of effective methods of contraception include oral or injected contraceptives or double barrier methods such as condom plus spermicide or condom plus diaphragm.

Cohort 3 (efficacy):See Cohort 2 exclusion criteria with the excluding of criteria 3, and the additional criteria below:1. Known DPD deficiency or UGT-1A1 polymorphism2. Patients with liver metastases that are IMMEDIATELY amenable to surgical resection without neoadjuvant treatment3. Patients for whom IMMEDIATE ablation is felt to be appropriate4. Patients who have metastatic disease outside of the liver that is likely to progress significantly over the next 3 months and limit life expectancy and prevent measurement of the required endpoints of the study in terms of response within the liver

In Cohort 1 (Safety), patients will not receive any routine cancer drugs to treat their cancer. Therefore, there are no expected benefits from taking part in this study.
For Cohort 2 (Performance) there will likely be no benefit to patients from taking part in this study and receiving either the small amount of drugs alone; or the small amount plus the SonoTran Platform intervention. It is hoped that by patients taking part in the study, the researchers will learn about whether the SonoTran Platform intervention helps drugs to get into tumour nodules at greater concentrations, and deeper into the tumours, which will provide evidence that the intervention may increase the effectiveness of the cancer drugs. However, the researchers will not know the answer to this until they have completed the whole of this study.
All patients in Cohort 3 (Efficacy) will receive routine anticancer treatment and half of the patients will in addition receive the SonoTran Platform intervention. For patients who receive the standard anticancer treatments alone, the chances of response should be the same as if they were receiving these treatments outside of the trial. For those patients who also receive the SonoTran intervention, it is hoped that the extra intervention may increase the amount of chemotherapy drug reaching the tumour, and it is hoped that for some individuals, this may then improve the chances of response to the routine anticancer treatment. However, this improvement, compared to standard anticancer treatment alone, cannot be guaranteed as this has not yet been tested in this way in human beings.
By entering this study patients will be making a significant contribution to a study that will provide information to increase our knowledge of the SonoTran Platform, which may help us to improve the future treatment of patients with metastatic colorectal cancer, with metastases to the liver.
As the SonoTran Particles and SonoTran System have never been used on patients before, the risks of both medical devices are unknown, so there is the risk that these interventions may cause side effects that we do not yet know about.
Based on the preclinical (animal) testing of SonoTran Particles the following side effects may occur - mild inflammation of the liver, a reaction or inflammation locally in the vein (where the particles go in). It is also possible that unexpected side effects could occur.
For the standard chemotherapy treatment, potential side effects may include but are not limited to: skin reactions e.g. rash, chills, dizziness, diarrhoea, anaemia (low number of red blood cells), shortness of breath, sore mouth, feeling sick (nausea), hair loss, fever, tiredness (fatigue), dehydration, headache, vomiting, lowered resistance to infection. (This treatment can potentially reduce the production of white blood cells by the bone marrow, making patients more prone to infection. This is potentially life-threatening and needs prompt assessment and treatment)

Testing if the SonoTran Platform can enhance drug delivery in metastatic colorectal cancer

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Testing if the SonoTran Platform can enhance drug delivery in metastatic colorectal cancer

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