Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.

Sponsor
Ming Liu
Study ID
NCT07655661
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    Oxaliplatin 130 mg/m² administered intravenously on Day 1 of each 21-day treatment cycle as part of the CAPOX regimen.
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m² orally twice daily on Days 1-14 of each 21-day treatment cycle.
  • Tislelizumab — DRUG
    Tislelizumab 200 mg administered intravenously on Day 1 of each 21-day treatment cycle.
  • Mannatide — DRUG
    Mannatide 10 mg administered orally three times daily throughout study treatment.

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CAPOX + Tislelizumab + Mannatide
    Participants will receive CAPOX chemotherapy (oxaliplatin and capecitabine), tislelizumab, and oral mannatide as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From treatment initiation until disease progression, assessed every 6 weeks during induction treatment and every 6 to 8 weeks during maintenance treatment, up to 24 months. ]

Central Contacts

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