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The Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota

NCT07400354 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-02-10

No results posted yet for this study

Summary

This study is designed as a single-center, open-label, phase II exploratory trial. Patients with advanced or locally advanced gastric cancer who have not received chemotherapy or immunotherapy before are eligible for inclusion. They will receive a first-line two-drug combination chemotherapy regimen (FOLFOX, XELOX, or SOX, determined by the attending physician) in combination with a PD-1 monoclonal antibody (nivolumab, sintilimab, tislelizumab, or pembrolizumab, determined by the attending physician). Fruquintinib can be added on this basis (only for patients enrolled in the HMPL-013-SH-GC103 study). The aim is to evaluate whether the gut microbiota has a predictive role in the efficacy of immunotherapy combined with chemotherapy for metastatic gastric cancer. A total of 100 patients will be enrolled in the study.

Gut microbiota will be measured at the following three time points:

1. Within 3 days before the first chemotherapy (designated as time 0)
2. Within 3 days before the third chemotherapy (designated as time 1)
3. After the sixth chemotherapy cycle, or within 1 week after disease progression if it occurs within the sixth cycle (designated as time 2)

Conditions

Interventions

OTHER

Observational study, no intervention

Observational study, no intervention

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2027-03-14
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400354 on ClinicalTrials.gov