AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Conversion Therapy of RAS/BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases

RecruitingPhase 3Ages 18 Years - 75 YearsAllFudan University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Evidence suggests that the addition of cetuximab or bevacizumab to doublet regimens could improve response rate and resectability rate of liver metastases and survival in colorectal liver metastases (CRLM). Moreover, it is observed that FOLFOXIRI yields higher response and resection rates compared with doublet regimens. However, which is better in conversion therapy of RAS/BRAF wild-type initially unresectable CRLM, FOLFOXIRI plus cetuximab or bevacizumab, remains unknown. In this study, RAS/BRAF wild-type colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be randomised between modified FOLFOXIRI (mFOLFOXIRI) plus cetuximab and mFOLFOXIRI plus bevacizumab. Patient imaging will be reviewed for resectability by MDT, consisting of at least one radiologist and

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 3 months 6. Good hematological function: neutrophil โ‰ฅ 1.5x109 / L and platelet count โ‰ฅ 100x109 / L; HB โ‰ฅ 9g / dl (within one week before randomization) 7. Normal liver and kidney function: serum bilirubin โ‰ค 1.5x normal upper limit (ULN), alkaline phosphatase โ‰ค 5x ULN, serum transaminase (AST or ALT) โ‰ค 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 ฮฒ - 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
๐Ÿ’Š

What it tests

  • mFOLFOXIRI plus Cetuximab
  • mFOLFOXIRI Plus Bevacizumab
๐Ÿ“

Where

1 site
Zhongshan Hospital, Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy