PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for RAS-mut MSS mCRC (NCT06206096) | Clinical Trial Compass
UnknownPhase 2
PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for RAS-mut MSS mCRC
China40 participantsStarted 2021-05-26
Plain-language summary
This study is designed to explore the efficacy and safety of anti-PD-1 antibody plus bevacizumab and chemotherapy as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed non resectable, locally advanced or metastatic colorectal cancer;
* No previous anti-tumor treatment for metastatic diseases;
* KRAS/NRAS mutation;
* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
* Life expectancy ≥ 3 months;
* Adequate organ and bone marrow functions:
Absolute neutrophil count≥1.5x10\^9/L; Platelet count≥100x10\^9/L; Hemoglobin≥9g/dL; Serum bilirubin\<1.5x the upper limit of normal(ULN); Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)\<1.5x ULN; Serum creatinine\<1.5x ULN; Endogenous creatinine clearance rate ≥ 50ml / min;
* Women of childbearing age need to take effective contraceptive measures.
Exclusion Criteria:
* Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors;
* With BRAF mutation or MSI-H status;
* Other untreated or concurrent tumors (except cervical carcinoma in situ, treated basal cell carcinoma or superficial bladder tumor, or if the tumor is cured and there is no evidence of disease for more than 3 years);
* Have received other systemic anti-tumor treatments, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy within 4 weeks before enrollment;
* There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment;
* Have received any surgery or invasive treatment or operation within 4 wee…