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NCT Number: NCT07646574

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Recurrence-free survival (RFS)

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

    The recurrence-free survival time of gastric cancer patients

  2. Overall survival (OS)

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

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

Sponsors and collaborators

Lead sponsor

Yong Zhou

Other

Registry information

Official study title

Non-surgical Management After Neoadjuvant Immunotherapy for Locally Advanced dMMR/MSI-H Gastric Cancer: WWWGC Phase II Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.