Status:
RECRUITING
mFOLFOXIRI+Bev vs. mFOLFOX6+Bev for RAS Mutant Unresectable Colorectal Liver-limited Metastases
Lead Sponsor:
Fudan University
Conditions:
Colorectal Carcinoma
Liver Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Colorectal cancer patients with initially unresectable liver-only metastases may be cured after downsizing of metastases by conversion therapy. However, the optimal regimen of conversion therapy for R...
Detailed Description
Patients will be stratified for primary tumor location (right-sided or left sided), numbers of liver metastases (\<5 or ≥5) and primary tumor resected or unresected. Patients with RAS mutated primary...
Eligibility Criteria
Inclusion
- Histological proof of colorectal adenocarcinoma;
- Age ≥ 18 years and ≤75 years;
- Simultaneous liver-limited metastases;
- Initially unresectable liver metastases determined by a local MDT;
- RAS mutation and BRAF V600E wild-type;
- At least one measurable liver metastasis;
- Initially resectable primary tumor or primary tumor already resected;
- World Health Organization (WHO) performance status 0-1;
- Life expectancy ≥ 3 months;
- Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥100×109/l, and hemoglobin(HB) ≥ 9g/dl;
- Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min;
- Written informed consent.
Exclusion
- Previous systemic treatment for metastatic disease;
- Previous surgery for metastatic disease;
- Extrahepatic metastases;
- Unresectable primary tumor;
- Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
- Acute or subacute intestinal obstruction;
- Second primary malignancy within the past 5 years;
- Drug or alcohol abuse;
- No legal capacity or limited legal capacity;
- Pregnant or lactating women;
- Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
- Peripheral neuropathy;
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT04781270
Start Date
April 15 2021
End Date
March 30 2026
Last Update
September 27 2021
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032