Estado del programa
ReclutamientoFase
Fase 3Inmunoterapia previa permitida
NoEnsayo dirigido por el CRC
SíDrogas
mFOLFOXIRI Plus Bevacizumab, mFOLFOXIRI plus CetuximabEtiquetas
MSI-H/ MMRd, MSS/ MMRpUbicación | Situación |
---|---|
China | |
Zhongshan Hospital, Fudan University Shanghai, Shanghai 200032 |
Reclutamiento |
Contactos
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