OncoMatch/Clinical Trials/NCT06580574
Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers
Is NCT06580574 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including PD1/PDL1 antibody monotherapy, up to 24 weeks and Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks for gastric cancer.
Treatment: PD1/PDL1 antibody monotherapy, up to 24 weeks · Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks — This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Gastric Cancer
Colorectal Cancer
Biomarker criteria
Required: MSH2 deficient mismatch repair
dMMR confirmed by immunohistochemistry
Required: MSH6 deficient mismatch repair
dMMR confirmed by immunohistochemistry
Required: MLH1 deficient mismatch repair
dMMR confirmed by immunohistochemistry
Required: PMS2 deficient mismatch repair
dMMR confirmed by immunohistochemistry
Required: MSI high microsatellite instability
MSI-H confirmed by PCR and NGS
Disease stage
Excluded: Stage DISTANT METASTASIS
without distant metastasis based on CR or MR
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: ctla4 blockade
Lab requirements
Blood counts
HGB ≥ 80g/L, NEU ≥ 1.0×10^9/L, PLT ≥ 75×10^9/L
Kidney function
Cr≤1.5×ULN or CrCl≥50mL/min (Cockcroft-Gault method)
Liver function
TBiL ≤ 1.5×ULN, ALT and AST ≤3 ×ULN
For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib. subjects should have good organ function within the first 7 days of initial dosing: HGB ≥ 80g/L, NEU ≥ 1.0*10^9/L, PLT ≥ 75*10^9/L, Cr≤1.5×ULN or CrCl≥50mL/min（Cockcroft-Gault method), TBiL ≤ 1.5×ULN, ALT and AST ≤3 ×ULN; urine protein <2+; if urine protein ≥ 2+, 24 hour urinary protein quantity <2g; INR, APTT, PT ≤ 1.5 ×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06580574 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ctla4 blockade disqualifies patients from enrollment.
Does this trial require MSH2?
Yes, MSH2 deficient mismatch repair is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 deficient mismatch repair is a required biomarker for enrollment.
Does this trial require MLH1?
Yes, MLH1 deficient mismatch repair is a required biomarker for enrollment.
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 qualify