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

NCT06914687 | Active Not Recruiting Phase 2

• 1 other identifier: SOLIDS-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Adenocarcinoma; Peritoneal Metastasis; Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma

Keywords

gastric cancer; Peritoneal Metastasis; Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• One year overall survival

  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 (3)

• R0 resection rate

  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)

  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)

  From the initiation date of first cycle (each cycle is 21 days) to the date of last cycle, an average of 12 weeks

Study Arms (1)

Tislelizumab plus SOX and HIPEC

EXPERIMENTAL

Tislelizumab, chemotherapy (SOX), and HIPEC(Docetaxel or paclitaxel)

Drug: Tislelizumab; Drug: S-1; Drug: Oxaliplatin; Drug: Docetaxel; Drug: Paclitaxel

Interventions

Tislelizumab DRUG

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

Tislelizumab plus SOX and HIPEC

S-1 DRUG

40\~60mg Bid，d1\~14, q3w

Tislelizumab plus SOX and HIPEC

Oxaliplatin DRUG

130mg/m2，iv drip for 2h，d1, q3w

Tislelizumab plus SOX and HIPEC

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)

Tislelizumab plus SOX and HIPEC

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)

Tislelizumab plus SOX and HIPEC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

tislelizumab; S 1 (combination); Oxaliplatin; Docetaxel; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

CN (1)