OncoMatch/Clinical Trials/NCT06543836
ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer
Is NCT06543836 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and Fruquintinib or Regorafenib for metastatic colorectal cancer.
Treatment: Sintilimab · Fruquintinib or Regorafenib · Fruquintinib — The efficacy of combining TKI with PD-1 inhibitor in the treatment of advanced MSS/pMMR colorectal cancer with low levels of maxVAF in peripheral blood ctDNA failed with standard treatment was assessed, compared to standard treatment as chosen by researchers.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
left-side RAS/BRAF wildtype
Required: NRAS wild-type
left-side RAS/BRAF wildtype
Required: BRAF wild-type
left-side RAS/BRAF wildtype
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine (5-fluorouracil, capecitabine)
previous treatment with fluoropyrimidine (5-fluorouracil or capecitabine)
Must have received: platinum-based chemotherapy (oxaliplatin)
previous treatment with...oxaliplatin
Must have received: topoisomerase inhibitor (irinotecan)
previous treatment with...irinotecan
Must have received: VEGF inhibitor (bevacizumab)
previous treatment with...bevacizumab
Must have received: EGFR-targeted therapy (cetuximab) — left-side RAS/BRAF wildtype
previous treatment with...cetuximab (left-side RAS/BRAF wildtype)
Cannot have received: VEGFR inhibitor (fruquintinib)
prior treatment with fruquintinib or similar small molecule oral targeted drugs primarily aimed at anti-angiogenesis
Cannot have received: anti-PD-1 therapy
prior treatment with other PD-1/PD-L1/CTLA-4 antibody therapies or other immunotherapies targeting PD-1/PD-L1/CTLA-4
Cannot have received: anti-PD-L1 therapy
prior treatment with other PD-1/PD-L1/CTLA-4 antibody therapies or other immunotherapies targeting PD-1/PD-L1/CTLA-4
Cannot have received: anti-CTLA-4 therapy
prior treatment with other PD-1/PD-L1/CTLA-4 antibody therapies or other immunotherapies targeting PD-1/PD-L1/CTLA-4
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin ≥9.0 g/dL
Kidney function
Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50ml/min, Urinalysis showing urine protein <2+, for patients with baseline urine protein ≥2+, 24-hour urine protein collection should show <1g
Liver function
Total bilirubin (TBIL) ≤1.5× ULN, ALT and AST ≤2.5× ULN, or ≤5× ULN in the presence of liver metastasis
Cardiac function
Normal electrocardiogram, LVEF ≥50%
Adequate organ and bone marrow function, with laboratory values within the following limits within 7 days before enrollment: ... Normal electrocardiogram, left ventricular ejection fraction (LVEF) ≥50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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