Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers
NCT06580574 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2026-05-15
Summary
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
Conditions
- Gastric Cancer
- Colon Cancer
- MSI-H
- DMMR Cancer
Interventions
- DRUG
-
PD1/PDL1 antibody monotherapy, up to 24 weeks
non-specific, according to Drug Instructions
- COMBINATION_PRODUCT
-
Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks
Sintilimab 200mg, ivgtt, q21d; IBI310 1mg/kg, ivgtt, q42d; Lenvatinib 8mg (starting from 4mg), po, qd
- PROCEDURE
-
Radical surgery
Radical surgery will be recommended per local treatment standards.
Sponsors & Collaborators
-
Peking University
lead OTHER
Principal Investigators
-
Lin Shen · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-13
- Primary Completion
- 2029-06-01
- Completion
- 2029-06-01
Countries
- China
Study Locations
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