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

July 26, 2026 updated by: Fenglin Liu, Fudan University

Tirellizumab Combined With SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: A Single-arm, Phase II Clinical Trial (Solids-03)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of gastric and gastroesophageal junction adenocarcinoma is increasing, and it is one of the most common malignant tumors in China. Surgery is the only possible way to cure gastric and gastroesophageal junction adenocarcinoma. Peritoneal metastasis is one of the most common modes of spread of gastric cancer. For gastric cancer with peritoneal metastasis, surgical treatment alone can not improve overall survival. Perioperative immunotherapy plus chemotherapy can downstage tumor T and N stage, increase the R0 resection rate, and may improve the long-term survival. Currently, surgical treatment combined with hyperthermic intraperitoneal chemotherapy (HIPEC) and systemic chemotherapy has demonstrated promising outcomes in both the treatment and prevention of peritoneal metastasis in gastric cancer. However, the therapeutic effects of immunotherapy combined with chemotherapy and HIPEC for gastric cancer with peritoneal metastasis remains unclear to date. Combination of perioperative tislelizumab and SOX plus HIPEC for peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase conversion resection rate and overall survival. This monocenter, single-arm phase 2 clinical trial aims to evaluate the effectiveness of tislelizumab plus SOX and HIPEC regimens in patients with peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma to determine the optimal therapeutic approach.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Fudan University Shanghai Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Signed informed consent Patients age 18-75 years Histologically CT/MRI confirmed cT3-4NanyM1 gastric or GEJ adenocarcinoma; Peritoneal metastasis was confirmed by laparoscopy (with or without Krukenberg tumor ) The degree of peritoneal metastasis ≤P1b or PCI≤13 points ECOG 0-1, no surgery contraindications; Expected survival ≥3 months;

Exclusion Criteria:

Prior chemotherapy, radiotherapy, surgery for gastric cancer; Signs of other distant metastases (e.g., liver, lung, bone, supraclavicular lymph, etc.) Significant cardiovascular disease Major surgical procedure within 4 weeks prior to initiation of study treatment Current treatment with anti-viral therapy or HBV Pregnancy or breastfeeding History of malignancy within 5 years prior to screening Present or history of any autoimmune disease or immune deficiency Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors Poorly controlled hypertension or diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tislelizumab plus SOX and HIPEC
Tislelizumab, chemotherapy (SOX), and HIPEC(Docetaxel or paclitaxel)
Drug: Oxaliplatin
130mg/m2，iv drip for 2h，d1, q3w
Drug: Tislelizumab
recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg ivdrip，d1, q3w
Drug: S-1
40~60mg Bid，d1~14, q3w
Drug: Docetaxel
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)
Drug: Paclitaxel
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Proportion of enrolled subjects who undergo microscopically margin-negative (R0) resection.
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Major Pathological Response Rate (MPR)
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
The proportion of patients with less than 10% residual viable tumor cells in the resected specimen.
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Objective Response Rate (ORR)
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of last cycle, an average of 12 weeks
The proportion of patients achieving tumor shrinkage meeting specified criteria and maintaining it for a defined duration, encompassing both CR and PR cases. Tumor response is evaluated according to RECIST V1.1 criteria.
From the initiation date of first cycle (each cycle is 21 days) to the date of last cycle, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOLIDS-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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