Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.

NCT07655661 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025 Review (2538)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Keywords

Mannatide; Tislelizumab; CAPOX; Gastric Cancer; Gastroesophageal Junction Cancer; Metastatic Gastric Cancer; First-Line Treatment; Phase II Study

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1.

  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.

Secondary Outcomes (5)

• Overall Survival (OS)

  Up to 24 months

• Duration of Response (DoR)

  Up to 24 months

• Disease Control Rate (DCR)

  Up to 24 months

• Incidence of Adverse Events

  From first dose through 30 days after the last dose, up to 24 months.

• Quality of Life (QoL)

  Baseline through completion of study treatment, up to 24 months.

Study Arms (1)

CAPOX + Tislelizumab + Mannatide

EXPERIMENTAL

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.

Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab; Drug: Mannatide

Interventions

Oxaliplatin DRUG

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

CAPOX + Tislelizumab + Mannatide

Capecitabine DRUG

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

CAPOX + Tislelizumab + Mannatide

Tislelizumab DRUG

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

CAPOX + Tislelizumab + Mannatide

Mannatide DRUG

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

CAPOX + Tislelizumab + Mannatide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma.
• Unresectable recurrent or metastatic disease confirmed by imaging and surgical evaluation.
• Age 18 to 75 years.
• Expected survival greater than 3 months.
• No prior systemic therapy for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Previous neoadjuvant or adjuvant therapy is allowed if completed at least 6 months before enrollment without evidence of recurrence or progression.
• ECOG performance status 0-1.
• At least one measurable lesion according to RECIST version 1.1.
• Availability of tumor tissue for PD-L1 testing.
• Adequate hematologic, hepatic, renal, and coagulation function.
• Recovery of prior treatment-related toxicities to Grade 0-1 or baseline level.
• Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.
• Ability to understand and willingness to sign informed consent.

You may not qualify if:

• HER2-positive gastric or gastroesophageal junction adenocarcinoma.
• Squamous cell carcinoma, undifferentiated carcinoma, or mixed histology.
• Active or uncontrolled central nervous system metastases.
• Uncontrolled pleural effusion, ascites, or clinically significant pericardial effusion.
• Weight loss greater than 20% within 2 months before enrollment.
• Major surgery within 28 days before enrollment.
• Prior anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitor therapy.
• Active autoimmune disease requiring systemic treatment.
• Active hepatitis B, hepatitis C, or HIV infection.
• Interstitial lung disease or uncontrolled systemic disease.
• Significant cardiovascular disease within 6 months before enrollment.
• Known hypersensitivity to study drugs or their components.
• Participation in another interventional clinical trial within 4 weeks before enrollment.
• History of substance abuse or severe psychiatric disorder.
• History of rheumatic heart disease or known hypersensitivity to mannatide.

Sponsors & Collaborators

• Ming Liu: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Capecitabine; tislelizumab; polyactin A

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Ming Liu, MD

CONTACT

+8618980606324; liuming629@wchscu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: All participants will receive CAPOX chemotherapy, tislelizumab, and oral mannatide as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)