A Clinical Study Evaluating the Efficacy of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis

Phase Ⅱ Study of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis

This study is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Furthermore, it seeks to analyze the effects of this treatment strategy on overall survival (OS), progression-free survival (PFS), PCI and adverse reaction rates.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: HIPEC; Drug: SOX; Drug: Immune Checkpoint Inhibitors

Detailed Description

Gastric cancer with peritoneal metastasis represents an advanced stage of the disease, with a very poor prognosis for patients. It is crucial to develop more effective treatment options to improve their prognosis. CRS with HIPEC has shown promise in extending survival for these patients. Currently, a PCI value ≥12 is widely recognized as significantly impacting the prognosis of gastric cancer peritoneal metastasis.

Recent clinical trials have resulted in the global endorsement of immune checkpoint inhibitors as a third-line therapy for gastric cancer. In March 2020, the National Medical Products Administration (NMPA) granted approval for nivolumab to be used in advanced or recurrent patients with gastric or esophagogastric junction adenocarcinoma who have received two or more systemic treatments.

However, there remains a lack of widely accepted effective treatment regimens for patients with peritoneal metastasis of gastric cancer. The CSCO recommends that such patients be referred for standard advanced gastric cancer treatments or consider participation in clinical trials. Consequently, our center has developed a comprehensive treatment protocol involving systemic chemotherapy (SOX), immune checkpoint inhibitors (Tislelizumab) and HIPEC, aiming to investigate the safety of this regimen and further enhance the prognosis of patients with peritoneal metastasis from gastric cancer.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kaixiong Tao, PhD; Phone Number: 13507155452; Email: taokaixiong@hust.edu.cn
• Study Contact Backup: Name: Yuping Yin, PhD; Phone Number: 15927412321; Email: yinyuping2017@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Wuhan Union Hospital
      • Contact: Kaixiong Tao, PhD; Phone Number: 13507155452; Email: taokaixiong@hust.edu.cn
      • Contact: Yuping Yin, PhD; Phone Number: 15927412321; Email: yinyuping2017@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-75 years
2. Men, or non-pregnant and non-lactating women
3. Pathological diagnosis as gastric malignant tumor
4. diagnosis of peritoneal metastasis [peritoneal cancer index (PCI) ≤ 12 points] by laparoscopic exploration
5. Normal major organ function:

1) HB ≥ 90 g/L； ANC ≥ 1.5×109/L; plt ≥125×109/L; 2) TBIL<1.5ULN; ALT, AST <2.5ULN; Cr≤1.25ULN; ALB ≥ 30 g/L 6. Not receive radiation therapy, chemotherapy, targeted therapy, or immunotherapy.

7. Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1 8. Patients are volunteers, have signed informed consent, and agree to cooperate with investigators in data collection.

Exclusion Criteria:

1. Patients have other malignant tumors within the past 5 years.
2. Patients use immunosuppressant within 30 days prior to the initial use of tirelizumab, excluding nasal sprays and physiological doses of inhaled corticosteroids or systemic steroids from consideration.
3. Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases.
4. Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors.
5. Patients with epilepsy or other mental disorders.
6. Patients who are unable to undergo surgery due to severe heart, lung and vascular diseases.
7. Pregnant or lactating women.
8. Patients with other distant metastasis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIPEC combined with SOX and Tislelizumab; The participants volunteering to take HIPEC combined with SOX and immune checkpoint inhibitors will be assigned to this group.	Drug: HIPEC; HIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery.; Drug: SOX; Oxaliplatin, 130 mg, i.v. + S-1 (40 mg per dose for BSA <1.25; 60 mg per dose for BSA 1.25 to 1.5; 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle d1-14, q3w; Drug: Immune Checkpoint Inhibitors; Tislelizumab, 200 mg, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection rate	The proportion of patients who achieved R0 resection	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1,2,3-year OS rate	The proportion of patients who will be alive within 1/2/3 years after receiving surgery	up to 12/24/36-months follow-up
Progression-free Survival	Percentage of all patients who did not experience disease progression or death.	up to 36-months follow-up
Incidence and severity of adverse reactions and serious adverse events	The incidence of adverse events and serious adverse events (referring to CTCAE 5.0) will be analyzed.	up to 36-months follow-up

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Collaborators: BeiGene
• Investigators: Principal Investigator: Kaixiong Tao, PhD, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: HIPEC; Tislelizumab; SOX; Peritoneal Metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Stomach Neoplasms; Neoplasm Metastasis; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Immune Checkpoint Inhibitors
• Other Study ID Numbers: UHCT230584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No