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

Program Status

Recruiting

Phase

Phase 3

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

mFOLFOXIRI Plus Bevacizumab, mFOLFOXIRI plus Cetuximab

Tags

MSI-H/ MMRd, MSS/ MMRp
Location Location Status
China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai 200032
Recruiting

Contacts

Jianmin Xu, MD, Ph.D.
CONTACT
86-21-64041990 xujmin@aliyun.com
Wentao Tang, MD, Ph.D.
CONTACT
86-21-64041990 tangwt1988@163.com

Inclusion Criteria

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

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

NCT ID

NCT04687631

Date Trial Added

2020-12-29

Updated Date

2025-03-25