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NOT YET RECRUITING
NCT07655661
PHASE2

Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.

Sponsor: Ming Liu

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, single-arm phase II study evaluating the efficacy and safety of mannatide in combination with CAPOX chemotherapy and tislelizumab as first-line treatment for patients with recurrent or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. Eligible patients will receive oxaliplatin, capecitabine, tislelizumab, and oral mannatide. Tumor response will be assessed according to RECIST version 1.1. Patients without disease progression after induction treatment may continue maintenance therapy with capecitabine, tislelizumab, and mannatide. The primary objective is to evaluate objective response rate (ORR). Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), and safety. Exploratory analyses will investigate immune microenvironment changes and potential predictive biomarkers using blood, tumor tissue, and stool samples.

Official title: A Multicenter, Single-Arm, Phase II Study of Mannatide Combined With CAPOX and Tislelizumab as First-Line Treatment for Recurrent or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-07-01

Completion Date

2029-07-01

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m² administered intravenously on Day 1 of each 21-day treatment cycle as part of the CAPOX regimen.

DRUG

Capecitabine

Capecitabine 1000 mg/m² orally twice daily on Days 1-14 of each 21-day treatment cycle.

DRUG

Tislelizumab

Tislelizumab 200 mg administered intravenously on Day 1 of each 21-day treatment cycle.

DRUG

Mannatide

Mannatide 10 mg administered orally three times daily throughout study treatment.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China