NCT06580574

Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers

Sintilimab With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-08-13
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2024-08-30
• Last updated: 2024-08-30

Locations

1 site across 1 country: China