Non-surgical Management After NIT for dMMR/MSI-H GC | NCT07646574

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

NCT07646574

Sponsor

Yong Zhou

Status

Not yet recruiting

Last Update Posted

Jun 12, 2026Actual

Enrollment

12Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

May 4, 2026

First Submission Date that Met QC Criteria

Jun 9, 2026

First Posted Date

Jun 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample