OncoMatch/Clinical Trials/NCT05970302
XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC
Is NCT05970302 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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.
Frequently asked questions
Is NCT05970302 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KRAS?
Yes, KRAS mutation is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS mutation is a required biomarker for enrollment.
Does this trial require MLH1?
Yes, MLH1 proficient mismatch repair is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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