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NCT06914687

Efficacy of Tirellizumab Combined With Oral, Intravenous and Abdominal Chemotherapy in Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Not yet recruiting Phase 2 Last updated 6 April 2025
What this trial tests

Phase 2 trial testing Tislelizumab in Gastric Adenocarcinoma in 30 participants. Not yet recruiting.

Timeline
30 March 2025
Primary endpoint
1 April 2028
1 April 2028

Quick facts

Lead sponsorFudan University
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date30 March 2025
Primary completion1 April 2028
Estimated completion1 April 2028

Drugs / interventions tested

Conditions studied

Sponsor

Fudan University

Who can join

Adults 18 to 75, any sex, with Gastric Adenocarcinoma or Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma (cT3-4NanyM1), PD-1 antibody combined with chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) can downstage tumor stage, increase the conversion resection rate, and may improve the long-term survival. Tislelizumab, an anti-PD-1 antibody, has recently been proved in the first- and second-line standard treatment for advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma.In the subgroup analysis of RATIONALE-305 trial, tislelizumab also showed good efficacy in gastric/gastroesophageal junction adenocarcinoma patients with peritoneal metastasis. Combination of tirellizumab,SOX and HIPEC for peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative tirellizumab in combination with SOX and HIPEC in peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Tislelizumab

Trials testing the same drug.

Other recruiting trials for Gastric Adenocarcinoma

Currently open trials in the same condition.

Other Fudan University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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