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Liver-directed chemotherapy after surgery of liver metastases of colorectal cancer in patients with high risk of recurrence of their disease.
EU CTIS ID: 2025-523913-27-00
What this study is testing
The primary objective of the trial is to evaluate the efficacy of postoperative HAI of oxaliplatin plus IV chemotherapy after curative-intent resection of CRLM in patients at high risk in terms of PFS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, an impartial witness of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
- Adequate organ and marrow function as indicated by the following laboratory values: bilirubin < 1.5 x upper limit of normal values (ULN), aminotransferases < 5 ULN, alkaline phosphatase < 5 ULN, International normalized ratio (INR) < 1.5 ULN, platelets > 100,000/mm3, neutrophils>1500/mm3
- Women of childbearing potential must have a negative pregnancy test done within 30 days before randomisation and 72 hours prior treatment initiation
- Patients must agree to use adequate contraception methods for the duration of study treatment and : a. women of childbearing potential (WOCBP) must use highly effective contraception at least: - 15 months after the end of the treatment with oxaliplatin, - 6 months after the end of the treatment with fluorouracile and iri notecan b. men must use contraception at least: - 12 months after the end of the treatment with oxaliplatin, 3 months after the end of the treatment with fluorouracile and irinotecan.
- Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
- Patients must be affiliated to a Social Security System (or equivalent)
You likely can't join if
- Stage IV dMMR CRC
- Pregnant women or women who are breast-feeding
- Participation in another therapeutic trial within the 30 days prior to randomisation
- QT/QTc interval longer than 450 msec for men and longer than 470 msec for women
- Persistent toxicities related to prior treatment of grade > 1
- Known history of hypersensitivity to trial treatments or any of their excipients or : o for 5-fluorouracil in case of: potentially serious infection, patients with poor nutritional status, recent or concomitant treatment with brivudine, live attenuated vaccines, clinically significant active heart disease or myocardial infarction within 6 months o for oxaliplatin in case of severely impaired renal function (creatinine clearance less than 30 ml/min) o for irinotecan in case of: chronic inflammatory bowel disease and/or bowel obstruction, concomitant use with St John's Wort, live attenuated vaccines
See the full eligibility criteria
Who can join
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, an impartial witness of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
- Adequate organ and marrow function as indicated by the following laboratory values: bilirubin < 1.5 x upper limit of normal values (ULN), aminotransferases < 5 ULN, alkaline phosphatase < 5 ULN, International normalized ratio (INR) < 1.5 ULN, platelets > 100,000/mm3, neutrophils>1500/mm3
- Women of childbearing potential must have a negative pregnancy test done within 30 days before randomisation and 72 hours prior treatment initiation
- Patients must agree to use adequate contraception methods for the duration of study treatment and : a. women of childbearing potential (WOCBP) must use highly effective contraception at least: - 15 months after the end of the treatment with oxaliplatin, - 6 months after the end of the treatment with fluorouracile and iri notecan b. men must use contraception at least: - 12 months after the end of the treatment with oxaliplatin, 3 months after the end of the treatment with fluorouracile and irinotecan.
- Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
- Patients must be affiliated to a Social Security System (or equivalent)
- Age ≥ 18 years
- ECOG performance status 0-1
- Histologically confirmed stage IV pMMR CRC
- Resected CRLM by one- or two-stage procedures including reverse strategy
- Partial Response or Stability Disease (RECIST v1.1) to preoperative cytotoxic doublet or triplet IV chemotherapy +/- targeted agent before surgery
- Curative-intent (R0/R1 resection ± local ablation) surgery of 4 or more CRLM
- No macroscopic residual (hepatic or extra-hepatic) disease on postoperative CT scan within 4 weeks after surgery confirmed during local multidisciplinary tumor board (except up to 3 lung nodules < 10 mm deemed amenable to curative-intent resection/local ablation and non-resected primary tumor with no or mild symptoms)
- Eligible to HAI of oxaliplatin by (permanent or selective) catheterization defined as the absence of medical (any contraindication to oxaliplatin administration, mainly residual peripheral sensory neuropathy grade < 2) and technical (vascular anatomy to perform HAI chemotherapy) contraindications to administer oxaliplatin-based doublet or triplet chemotherapy within 8 weeks from surgery during at least 4 cycles evaluated by interventional radiologist and medical oncologist
What rules you out
- Stage IV dMMR CRC
- Pregnant women or women who are breast-feeding
- Participation in another therapeutic trial within the 30 days prior to randomisation
- QT/QTc interval longer than 450 msec for men and longer than 470 msec for women
- Persistent toxicities related to prior treatment of grade > 1
- Known history of hypersensitivity to trial treatments or any of their excipients or : o for 5-fluorouracil in case of: potentially serious infection, patients with poor nutritional status, recent or concomitant treatment with brivudine, live attenuated vaccines, clinically significant active heart disease or myocardial infarction within 6 months o for oxaliplatin in case of severely impaired renal function (creatinine clearance less than 30 ml/min) o for irinotecan in case of: chronic inflammatory bowel disease and/or bowel obstruction, concomitant use with St John's Wort, live attenuated vaccines
- Patients who already received 6 months of FOLFOX or 3 months of CAPOX as adjuvant therapy following resection of the primary tumor completed less than 6 months ago
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
- Persons deprived of their liberty or under protective custody or guardianship
- Incomplete (R2) surgery or residual (hepatic or extrahepatic) disease on postoperative CT scan within 4 weeks after surgery or symptomatic primary tumours in case of reverse strategy
- Previous history of colorectal liver metastases treated with curative intent
- Patients with contraindications for HAI or IV doublet or triplet administration as limiting anatomical variations of hepatic artery, peripheral sensory neuropathy ≥ grade 2 (NCICTAE v.5.0), gastric/duodenal ulcer or significant chronic liver disease (resulting in portal hypertension and/or liver failure)
- Patient with a dihydropyrimidine dehydrogenase deficiency (DPD)
- Ionic disorders as: a. Potassium < 3,5 mEq/L (< 3,5 mmol/L) b. Magnesium < 1,8 mg/dL (< 0,70 mmol/L) c. Total serum calcium concentration < 8.8 mg/dL (< 2.20 mmol/L)
- Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥5 years
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.