Treatment for colorectal cancer patients with liver metastases that can't be surgically removed

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 two different treatment regimens for patients with RAS/BRAF wild-type colorectal cancer and initially unresectable liver metastases. Participants will be randomly assigned to receive either modified FOLFOXIRI combined with cetuximab or modified FOLFOXIRI combined with bevacizumab. The study aims to determine which combination improves the chances of making liver metastases resectable and enhances overall survival. Patients will be monitored through imaging assessments every eight weeks to evaluate their response to treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The primary tumor was confirmed by histology as colorectal adenocarcinoma
2. Initially unresectable liver metastases suggested by MDT
3. RAS/BRAF gene wild-type states
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy ≥ 3 months
6. Good hematological function: neutrophil ≥ 1.5x109 / L and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
7. Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization);
8. Sign the written informed consent to participate in the experiment

Exclusion Criteria:

1. Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
2. Known or suspected extrahepatic metastasis
3. Patients with known hypersensitivity to any component of the study treatment
4. Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
5. Acute or subacute intestinal obstruction
6. Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
7. Other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
8. Known drug / alcohol abuse
9. No legal capacity or limited legal capacity

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jianmin Xu, MD, Ph.D. — Fudan University
• Study coordinator: Jianmin Xu, MD, Ph.D.
• Email: xujmin@aliyun.com
• Phone: 86-21-64041990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Bevacizumab, sintilimab, cetuximab and irinotecan in refractory RAS wild-type metastatic colorectal cancer

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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.