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

NCT ID: NCT06685887

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2027-12-31

Brief Summary

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.

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HIPEC

Intervention Type: DRUG

HIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery.

SOX

Intervention Type: DRUG

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

Immune Checkpoint Inhibitors

Intervention Type: DRUG

Tislelizumab, 200 mg, q3w

Interventions

HIPEC

HIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery.

Intervention Type: 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

Intervention Type: DRUG

Immune Checkpoint Inhibitors

Tislelizumab, 200 mg, q3w

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaixiong Tao, PhD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kaixiong Tao, PhD

Role: CONTACT

taokaixiong@hust.edu.cn

13507155452

Yuping Yin, PhD

Role: CONTACT

yinyuping2017@hust.edu.cn

15927412321

Facility Contacts

Kaixiong Tao, PhD

Role: primary

taokaixiong@hust.edu.cn

13507155452

Yuping Yin, PhD

Role: backup

yinyuping2017@hust.edu.cn

15927412321

Other Identifiers

UHCT230584

Identifier Type: -

Identifier Source: org_study_id