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Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.

ConditionsGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMing Liu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: CAPOX + Tislelizumab + MannatideExperimental treatment 4 interventions

Trial outcomes

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.

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.

Secondary outcomes

1

Overall Survival (OS)

Time frame
Up to 24 months
2

Duration of Response (DoR)

Time frame
Up to 24 months
3

Disease Control Rate (DCR)

Time frame
Up to 24 months
4

Incidence of Adverse Events

Adverse events assessed according to NCI CTCAE version 5.0.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ming Liu

Lead sponsor

West China Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: