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 (May 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.

Phase 2RecruitingPeking UniversityNCT06580574Data as of May 2026

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

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Extracted eligibility criteria

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.

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