OncoMatch/Clinical Trials/NCT05970302
XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC
Is NCT05970302 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine for tislelizumab.
Treatment: Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine — The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS/pMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a "hot tumor" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS mutation
RAS-mutant
Required: NRAS mutation
RAS-mutant
Required: MLH1 proficient mismatch repair
MSS/pMMR-type
Required: MSH2 proficient mismatch repair
MSS/pMMR-type
Required: MSH6 proficient mismatch repair
MSS/pMMR-type
Required: PMS2 proficient mismatch repair
MSS/pMMR-type
Disease stage
Required: Stage IV
Metastatic disease required
Histologically confirmed initially unresectable MSS/pMMR-type RAS-mutant metastatic colorectal adenocarcinoma; Have at least one measurable lesion (according to RECIST v1.1 standard)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy containing fluorouracil (fluorouracil) — neoadjuvant or adjuvant
Neoadjuvant or adjuvant chemotherapy containing fluorouracil drugs is allowed before or after radical resection of colorectal cancer, but the treatment needs to be completed for ≥ 6 months
Must have received: chemotherapy containing oxaliplatin (oxaliplatin) — neoadjuvant or adjuvant
if oxaliplatin is used in neoadjuvant or adjuvant chemotherapy, it includes The oxaliplatin regimen needs to be completed for ≥12 months
Cannot have received: bevacizumab (bevacizumab)
Previously received bevacizumab
Cannot have received: anti-CTLA-4 therapy
anti-CTLA4 therapeutic antibodies
Cannot have received: anti-PD-1 therapy
anti-PD-1 therapeutic antibodies
Cannot have received: anti-PD-L1 therapy
anti-PD-L1 therapeutic antibodies
Cannot have received: pathway-targeted drugs
pathway-targeted drugs
Lab requirements
Blood counts
white blood cells ≥ 3.5*10^9/L and neutrophils ≥ 1.5*10^9/L, hemoglobin ≥ 90g/L, platelets ≥ 100*10^9/L
Kidney function
serum creatinine ≤ 1.5 times of normal value, creatinine clearance rate ≥ 60ml/min
Liver function
serum bilirubin ≤ 1.5 times the normal value, ALT ≤ 2.5 times the normal value, AST ≤ 2.5 times the normal value
Cardiac function
LVEF ≥ lower limit of normal value (50%)
Adequate organ function: ...white blood cells ≥ 3.5*10^9/L and neutrophils ≥ 1.5*10^9/L, hemoglobin ≥ 90g/L, platelets ≥ 100*10^9/L; serum bilirubin ≤ 1.5 times the normal value, alanine aminotransferase (ALT) ≤ 2.5 times the normal value, aspartate aminotransferase (AST) ≤ 2.5 times the normal value; ...serum creatinine ≤ 1.5 times of normal value, creatinine clearance rate ≥ 60ml/min; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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