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

NCT06685887 | Recruiting Phase 2

• 1 other identifier: UHCT230584
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Peritoneal Metastasis; HIPEC; SOX; Tislelizumab

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  The proportion of patients who achieved R0 resection

  1 year

Secondary Outcomes (3)

• 1,2,3-year OS rate

  up to 12/24/36-months follow-up

• Progression-free Survival

  up to 36-months follow-up

• Incidence and severity of adverse reactions and serious adverse events

  up to 36-months follow-up

Study Arms (1)

HIPEC combined with SOX and Tislelizumab

EXPERIMENTAL

The participants volunteering to take HIPEC combined with SOX and immune checkpoint inhibitors will be assigned to this group.

Drug: HIPEC; Drug: SOX; Drug: Immune Checkpoint Inhibitors

Interventions

HIPEC DRUG

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

HIPEC combined with SOX and Tislelizumab

SOX 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

HIPEC combined with SOX and Tislelizumab

Immune Checkpoint Inhibitors DRUG

Tislelizumab, 200 mg, q3w

HIPEC combined with SOX and Tislelizumab

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patients have other malignant tumors within the past 5 years.
• 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.
• Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases.
• Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors.
• Patients with epilepsy or other mental disorders.
• Patients who are unable to undergo surgery due to severe heart, lung and vascular diseases.
• Pregnant or lactating women.
• Patients with other distant metastasis

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• BeiGene: collaborator

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Kaixiong Tao, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaixiong Tao, PhD

CONTACT

13507155452; taokaixiong@hust.edu.cn

Yuping Yin, PhD

CONTACT

15927412321; yinyuping2017@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: November 13, 2024
• Study Start: February 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)