RecruitingPhase 2NCT06580574

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


Sponsor

Peking University

Enrollment

38 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether immunotherapy drugs (immune checkpoint inhibitors) can shrink tumors enough to avoid surgery in patients with stomach or colon cancer that has not spread to other organs but has a specific genetic marker called dMMR/MSI-H. These tumors respond particularly well to immunotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stomach cancer or colon cancer confirmed by tissue biopsy - Your tumor has the dMMR or MSI-H genetic marker (your doctor can test for this) - Your cancer has not spread to distant organs **You may NOT be eligible if...** - Your cancer has already spread widely (metastatic) - You have a serious autoimmune disease - You have had prior chemotherapy or immunotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPD1/PDL1 antibody monotherapy, up to 24 weeks

non-specific, according to Drug Instructions

COMBINATION_PRODUCTIntensive 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

PROCEDURERadical surgery

Radical surgery will be recommended per local treatment standards.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06580574


Related Trials