Status:
UNKNOWN
Conversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases
Lead Sponsor:
Fudan University
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific con...
Eligibility Criteria
Inclusion
- The primary tumor was confirmed by histology as colorectal adenocarcinoma
- primary right-sided colorectal adenocarcinoma
- Radiologic evidence suggests that the initial unresectable liver metastases
- RAS/BRAF gene wild-type states
- ECOG was 0 \~ 1
- Life expectancy ≥ 3 months
- Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
- 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);
- Sign the written informed consent to participate in the experiment
Exclusion
- Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
- Known or suspected extrahepatic metastasis
- Patients with known hypersensitivity to any component of the study treatment
- Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
- Acute or subacute intestinal obstruction
- Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
- She had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
- Known drug / alcohol abuse
- No legal capacity or limited legal capacity
- There is peripheral neuropathy
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
584 Patients enrolled
Trial Details
Trial ID
NCT04525326
Start Date
October 1 2020
End Date
November 1 2022
Last Update
August 25 2020
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