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A Prospective, Phase II Clinical Study of HIPEC Combined With NIPS and Tislelizumab Conversion Therapy for Gastric Cancer With Peritoneal Metastasis With Positive Cytology Alone or PCI Score ≤10 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Prospective, Phase II Clinical Study of HIPEC Combined With NIPS and Tislelizumab Conversion Therapy for Gastric Cancer With Peritoneal Metastasis With Positive Cytology Alone or PCI Score ≤10

NCT07304258•Hebei Medical University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of HIPEC combined with NIPS and tislelizumab conversion therapy for gastric/gastroesophageal junction cancer with positive cytology alone (CY1P0) or a Peritoneal Carcinomatosis Index (PCI) ≤10

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Treatment-naïve patients who have not received chemotherapy, radiotherapy, or any other antitumor therapy prior to the start of the clinical trial;
•2. Age between 18 and 75 years;
•3. Male or non-pregnant, non-lactating female;
•4. Gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathological diagnosis;
•5. HER-2 negative by immunohistochemistry (IHC), and PD-L1 CPS ≥1;
•6. Laparoscopic exploration confirming either positive cytology alone (P0CY1) or peritoneal metastasis (PCI score ≤10);
•7. No other distant metastases;
•8. Hematological criteria: white blood cell count ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L;
•9. Biochemical criteria: ALT ≤2.5×ULN, AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;
•10. Left ventricular ejection fraction ≥50%;
+2 more criteria

Exclusion Criteria

•1. Inability to comply with the study protocol or procedures;
•2. Known HER2-positive status;
•3. Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types;
•4. Current conditions or diseases affecting drug absorption;
•5. Patients preoperatively confirmed as unsuitable for conversion therapy;
•6. Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension;
•7. Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth);
•8. Known allergy to the investigational drug(s);
•9. Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways;
•10. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (HBV DNA ≥1×10⁴ copies/mL or \>2000 IU/mL despite prior antiviral therapy); Known primary immunodeficiency or active tuberculosis; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known history of human immunodeficiency virus (HIV) infection (HIV antibody positive);
+8 more criteria

Locations (1)

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Key Dates

Start Date

December 12, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

December 26, 2025

Enrollment

ESTIMATED participants

Conditions

Gastric Cancer Peritoneal Metastases

Interventions

HIPEC

DEVICE

NIPS

DEVICE

Paclitaxel Injection, S-1, tislelizumab

DRUG