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Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.
Sponsor: Ming Liu
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
Oxaliplatin
Oxaliplatin 130 mg/m² administered intravenously on Day 1 of each 21-day treatment cycle as part of the CAPOX regimen.
Capecitabine
Capecitabine 1000 mg/m² orally twice daily on Days 1-14 of each 21-day treatment cycle.
Tislelizumab
Tislelizumab 200 mg administered intravenously on Day 1 of each 21-day treatment cycle.
Mannatide
Mannatide 10 mg administered orally three times daily throughout study treatment.
Locations (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, China