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NOT YET RECRUITING
NCT07304258
PHASE2

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

Sponsor: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-12-12

Completion Date

2027-12-31

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

DEVICE

HIPEC

HIPEC protocol: Paclitaxel Injection, 75mg/m², D1, D3, D5, for three cycles, followed by a two-week rest before initiating NIPS combined with systemic therapy.

DEVICE

NIPS

Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg/m² on D1 and D8; Q3W.

DRUG

Paclitaxel Injection, S-1, tislelizumab

Paclitaxel Injection: 50mg/m², iv, D1, D8; Q3W; Tegafur Gimeracil Oteracil Potassium Capsules (S-1):For body surface area (BSA) \<1.25, 40mg per dose; BSA ≥1.25 to \<1.5, 50mg per dose; BSA ≥1.5, 60mg per dose; po, bid, D1-D14; Q3W; Tislelizumab: 200mg per administration, intravenous drip over 30 minutes (not less than 20 minutes and not exceeding 60 minutes), D1, Q3W.

Locations (1)

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China