Actively Recruiting
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
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-04-11
34
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Male, or female who is not pregnant or breastfeeding
- Pathological diagnosis of gastric malignant tumor
- Diagnosis of peritoneal metastasis with peritoneal cancer index (PCI) 12 or less confirmed by laparoscopic exploration
- Normal major organ function including hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.5×10^9/L, platelets ≥ 125×10^9/L
- Total bilirubin less than 1.5 times upper limit of normal (ULN)
- ALT and AST less than 2.5 times ULN
- Creatinine less than or equal to 1.25 times ULN
- Albumin ≥ 30 g/L
- No prior radiation, chemotherapy, targeted therapy, or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Voluntary participation with signed informed consent and agreement to cooperate with data collection
You will not qualify if you...
- History of other malignant tumors within the past 5 years
- Use of immunosuppressants within 30 days before starting tislelizumab, excluding nasal sprays and physiological doses of inhaled or systemic corticosteroids
- Ongoing or prior autoimmune diseases
- Allergies to oxaliplatin, S-1, related chemotherapy drugs, or immune checkpoint inhibitors
- Epilepsy or other mental disorders
- Severe heart, lung, or vascular diseases preventing surgery
- Pregnant or breastfeeding women
- Presence of other distant metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
K
Kaixiong Tao, PhD
CONTACT
Y
Yuping Yin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here