Non-surgical Management After NIT for dMMR/MSI-H GC

NCT07646574 | Not Yet Recruiting

• 1 other identifier: ChiCTR2600120174
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gastric cancer is one of the most common cancers worldwide and has a poor prognosis Immunotherapy significantly improves the prognosis of gastric cancer. In resectable gastric/gastroesophageal junction adenocarcinoma (GAC/GEJA) C, mismatch repair deficiency (dMMR)/microsatellite instability (MSI-H) can improve survival, and immunotherapy can avoid chemotherapy or surgery. The dMMR/MSI-H status is the strongest predictive biomarker for the benefit of immunotherapy with anti-programmed death receptor 1 and its ligands (PD-1/PD-L1) in advanced solid tumors, especially metastatic gastric/gastroesophageal junction adenocarcinoma. The INFINITY study provides Durvalumab combined with Tremelimumab as a treatment option with significant benefits for preoperative treatment of dMMR/MSI GAC/GEJAC, as well as the feasibility of non-surgical treatment strategies for such gastric cancer patients At present, there are no studies related to Asian gastric cancer patients, which are worthy of further verification and exploration in Asian gastric cancer cohorts.

Conditions

Non-surgical Management;dMMR/MSI-H Gastric Cancer;Neoadjuvant Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Recurrence-free survival (RFS)

  The recurrence-free survival time of gastric cancer patients

  One year, three years, or five years after the end of immunotherapy

• Overall survival (OS)

  The period from the start of randomization grouping in a clinical trial to the death of a patient for any cause

  One year, three years, or five years after the end of immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old with advanced dMMR/MSI-H gastric cancer

You may qualify if:

• Patients over 18 years old with advanced dMMR/MSI-H gastric cancer; Neoadjuvant therapy is needed (immunotherapy, chemotherapy + immunotherapy); The patient voluntarily and agreed to join the clinical research.

You may not qualify if:

• Gastric cancer combined with invasion and metastasis; Gastric cancer combined with other malignant tumors; Gastric cancer combined with dysfunction of other organs; Unwilling to participate in clinical research.

Sponsors & Collaborators

• Yong Zhou: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-05