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

Estado del programa

Reclutamiento

Fase

Fase 3

Inmunoterapia previa permitida

No

Ensayo dirigido por el CRC

Drogas

mFOLFOXIRI Plus Bevacizumab, mFOLFOXIRI plus Cetuximab

Etiquetas

MSI-H/ MMRd, MSS/ MMRp
Ubicación Situación
China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai 200032
Reclutamiento

Contactos

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

Criterios de inclusión

Criterios de inclusión:

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

Criterios de exclusión

Criterios de exclusión:

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

Fecha en que se añadió el juicio

2020-12-29

Fecha de actualización

2025-03-25