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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2025-04-11
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
Interventions
- 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
Sponsors & Collaborators
-
BeiGene
collaborator INDUSTRY -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Kaixiong Tao, PhD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-15
- Primary Completion
- 2027-07-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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