Gastric AdenocarcinomaPhase 2NCT07655661
Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.
A Phase 2 study testing Oxaliplatin, Capecitabine and Tislelizumab in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Ming Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Oxaliplatin, Capecitabine and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Ming Liu, +8618980606324, liuming629@wchscu.cn
About this study
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.
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.
Read the detailed description
Gastric cancer remains one of the leading causes of cancer-related mortality worldwide. Although immune checkpoint inhibitors combined with chemotherapy have improved outcomes in advanced gastric and gastroesophageal junction adenocarcinoma, many patients still fail to achieve durable responses.
Mannatide is an immunomodulatory agent that has been shown to enhance both innate and adaptive immune responses. Preclinical and clinical studies suggest that mannatide may improve antitumor immunity through activation of macrophages, enhancement of antigen presentation, stimulation of T-cell proliferation, and promotion of natural killer cell activity. These properties provide a rationale for combining mannatide with chemotherapy and immune checkpoint blockade.
This study is a multicenter, open-label, single-arm phase II trial enrolling approximately 52 patients with unresectable recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Participants will receive CAPOX chemotherapy (oxaliplatin plus capecitabine), tislelizumab, and oral mannatide as first-line treatment.
Treatment will be administered for six induction cycles. Tumor assessments will be performed every two cycles according to RECIST version 1.1. Patients without disease progression may continue maintenance therapy consisting of capecitabine, tislelizumab, and mannatide until disease progression, unacceptable toxicity, withdrawal of consent, initiation of another anticancer therapy, death, or completion of the maximum treatment duration.
The primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), and safety. Exploratory endpoints include single-cell RNA sequencing, single-cell T-cell receptor sequencing, multiplex immunofluorescence analysis, and gut microbiome profiling to identify biomarkers associated with treatment response.
- Being tested
- Oxaliplatin, Capecitabine, Tislelizumab, Mannatide
- Keywords
- Mannatide, Tislelizumab, CAPOX, Gastric Cancer, Gastroesophageal Junction Cancer, Metastatic Gastric Cancer, First-Line Treatment, Phase II Study
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Oxaliplatin 130 mg/m² administered intravenously on Day 1 of each 21-day treatment cycle as part of the CAPOX regimen.
CapecitabineDrug
Capecitabine 1000 mg/m² orally twice daily on Days 1-14 of each 21-day treatment cycle.
TislelizumabDrug
Tislelizumab 200 mg administered intravenously on Day 1 of each 21-day treatment cycle.
MannatideDrug
Mannatide 10 mg administered orally three times daily throughout study treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab; Drug: Mannatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Up to 24 months
Duration of Response (DoR)
Measured: Up to 24 months
Disease Control Rate (DCR)
Measured: Up to 24 months
Incidence of Adverse Events
Adverse events assessed according to NCI CTCAE version 5.0.
Measured: From first dose through 30 days after the last dose, up to 24 months.
Quality of Life (QoL)
Quality of life assessed using the EORTC QLQ-C30 questionnaire.
Measured: Baseline through completion of study treatment, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive CAPOX chemotherapy, tislelizumab, and oral mannatide as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655661
- Sponsor's protocol ID
- 2025 Review (2538)
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07655661
- Acronym / sponsor ID
- 2025 Review (2538)
- Keywords
- Mannatide, Tislelizumab, CAPOX, Gastric Cancer, Gastroesophageal Junction Cancer, Metastatic Gastric Cancer, First-Line Treatment, Phase II Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ming LiuUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gastric cancer remains one of the leading causes of cancer-related mortality worldwide. Although immune checkpoint inhibitors combined with chemotherapy have improved outcomes in advanced gastric and gastroesophageal junction adenocarcinoma, many patients still fail to achieve durable responses.
Mannatide is an immunomodulatory agent that has been shown to enhance both innate and adaptive immune responses. Preclinical and clinical studies suggest that mannatide may improve antitumor immunity through activation of macrophages, enhancement of antigen presentation, stimulation of T-cell proliferation, and promotion of natural killer cell activity. These properties provide a rationale for combining mannatide with chemotherapy and immune checkpoint blockade.
This study is a multicenter, open-label, single-arm phase II trial enrolling approximately 52 patients with unresectable recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Participants will receive CAPOX chemotherapy (oxaliplatin plus capecitabine), tislelizumab, and oral mannatide as first-line treatment.
Treatment will be administered for six induction cycles. Tumor assessments will be performed every two cycles according to RECIST version 1.1. Patients without disease progression may continue maintenance therapy consisting of capecitabine, tislelizumab, and mannatide until disease progression, unacceptable toxicity, withdrawal of consent, initiation of another anticancer therapy, death, or completion of the maximum treatment duration.
The primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), and safety. Exploratory endpoints include single-cell RNA sequencing, single-cell T-cell receptor sequencing, multiplex immunofluorescence analysis, and gut microbiome profiling to identify biomarkers associated with treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive CAPOX chemotherapy, tislelizumab, and oral mannatide as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
| Arm | Type | Receives |
|---|---|---|
| CAPOX + Tislelizumab + Mannatide | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Tislelizumab, Drug: MannatideParticipants will receive CAPOX chemotherapy (oxaliplatin and capecitabine), tislelizumab, and oral mannatide as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinOxaliplatin 130 mg/m² administered intravenously on Day 1 of each 21-day treatment cycle as part of the CAPOX regimen. | Drug | CAPOX + Tislelizumab + Mannatide |
| CapecitabineCapecitabine 1000 mg/m² orally twice daily on Days 1-14 of each 21-day treatment cycle. | Drug | CAPOX + Tislelizumab + Mannatide |
| TislelizumabTislelizumab 200 mg administered intravenously on Day 1 of each 21-day treatment cycle. | Drug | CAPOX + Tislelizumab + Mannatide |
| MannatideMannatide 10 mg administered orally three times daily throughout study treatment. | Drug | CAPOX + Tislelizumab + Mannatide |
Primary outcome
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.
Objective response rate defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1.
5 secondary outcomes
Overall Survival (OS)
Time frame: Up to 24 months
Duration of Response (DoR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Incidence of Adverse Events
Time frame: From first dose through 30 days after the last dose, up to 24 months.
Quality of Life (QoL)
Time frame: Baseline through completion of study treatment, up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Capecitabine and Tislelizumab in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Ming Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Liu, MD (+8618980606324, liuming629@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.