Treatment for liver metastases in colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of systemic oxaliplatin and intra-arterial chemotherapy combined with LV5FU2, with or without irinotecan and targeted therapy, for patients with metastatic colorectal cancer confined to the liver. The study aims to improve treatment outcomes by enhancing the response rates and overall survival in patients who are not candidates for surgical resection. Participants will receive a combination of intravenous and intra-arterial chemotherapy, focusing on those with specific genetic markers and measurable liver metastases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
* At least one measurable hepatic metastasis according to the criteria RECIST v1.1
* No other metastatic sites except lung nodules if number ≤ 3 and \< 10 mm
* RAS mutation status known (determination of KRAS mutation (exons 2,3 and 4) and determination of the NRAS mutation (exons 2,3 and 4))
* Age ≥ 18
* WHO ≤ 2 (Appendix 4)
* No prior treatment by chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
* Life expectancy \> 3 months
* PNN \> 1500/mm3, platelets \> 100 000/mm3, Hb \> 9 g/dLq
* Bilirubin \< 25 mmol/L, AST \< 5x ULN, ALT \< 5 x ULN, ALP \< 5 x ULN, TP \> 60%, proteinuria from 24H \< 1 g
* Creatinine clearance \> 50 mL/min according to MDRD formula (Appendix 4)
* Patient affiliated to a social security scheme
* Patient information and signature of the informed consent

Exclusion Criteria:

* Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.
* Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR
* Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack
* Hypertension not controlled by medical treatment (SBP \> 140 mmHg and/or DBP\> 90 mmHg with blood pressure taken according to the diagram of the HAS)
* A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
* Progressive gastroduodenal ulcer, wound or fractured bone
* Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment
* Transplant patients, HIV positive or other immune deficiency syndromes
* Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure
* Peripheral neuropathy \> 1
* Patient with interstitial pneumonitis or pulmonary fibrosis
* History of chronic diarrhea or inflammatory disease of the colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment
* History of malignant pathologies during the past 5 years except basocellular skin carcinoma considered in complete remission or in situ cervical carcinoma, properly treated
* Patient already included in another clinical trial with an experimental molecule
* Any known specific contraindication or allergy or hypersensitivity to the drugs used in the study (cf RCP Appendix 7)
* Known deficit in DPD
* QT/QTc range \> 450 msec for men and \> 470 msec for women
* K+ \< LNL, Mg2+ \< LNL, Ca2+ \< LNL
* Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test
* Persons deprived of liberty or under supervision
* Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons

Where it's running

• Hôpital Erasme
  Brussels, Belgium Recruiting
• Chu Hotel Dieu
  Angers, France Recruiting
• Institut de Cancérologie de l'Ouest
  Angers, France Recruiting
• Hôpital Privé d'Antony
  Antony, France Recruiting
• Institut du cancer Avignon Provence
  Avignon, France Recruiting
• Ch Cote Basque
  Bayonne, France Recruiting

Study contacts

• Principal investigator: Julien TAIEB, MD-PhD — HEGP, Paris
• Study coordinator: Sofia JOURDAN
• Email: sofia.jourdan@u-bourgogne.fr
• Phone: +33 (0)380393404

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.