NCT07655661Not yet recruitingPhase 2
Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.
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.
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 13 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Ming Liu
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07655661
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 52
- From 1 Jul 2026 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Significant cardiovascular disease within 6 months before enrollment.
- Participation in another interventional clinical trial within 4 weeks before enrollment.
Other illness
- Active autoimmune disease requiring systemic treatment.
- Active hepatitis B, hepatitis C, or HIV infection.
- Interstitial lung disease or uncontrolled systemic disease.
- Known hypersensitivity to study drugs or their components.
- History of substance abuse or severe psychiatric disorder.
- History of rheumatic heart disease or known hypersensitivity to mannatide.
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.