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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06543836 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior VEGFR inhibitor, anti-PD-1 therapy, anti-PD-L1 therapy disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages