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

ConditionsGastric AdenocarcinomaGastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal CarcinomaPeritoneal Metastasis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg ivdrip，d1, q3w

  • S-1

    Drug

    40\~60mg Bid，d1\~14, q3w

  • Oxaliplatin

    Drug

    130mg/m2，iv drip for 2h，d1, q3w

  • Docetaxel

    Drug

    Docetaxel at a dose of 20 mg/m2 or paclitaxel at a dose of 40 mg/m2 dissolved in 3-5 L of normal saline heated to 43 ± 0.5 °C for HIPEC.(d01-d03,qd,before first cycle of Tislelizumab and SOX)

  • Paclitaxel

    Drug

    Paclitaxel at a dose of 40 mg/m2 or docetaxel at a dose of 20 mg/m2 dissolved in 3-5 L of normal saline heated to 43 ± 0.5 °C for HIPEC.(d01-d03,qd,before first cycle of Tislelizumab and SOX)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Tislelizumab plus SOX and HIPECExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

One year overall survival

Time frame
From the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

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