Overview

Evaluating the Efficacy of Hyperthermic Intraperitoneal Treatment to Enhance the Sensitivity of Immune Checkpoint Inhibitor in Patients With Advanced Ovarian Cancer A Single-arm Study

Status:
NOT_YET_RECRUITING
Trial end date:
2030-01-01
Target enrollment:
Participant gender:
Summary
Background: Advanced ovarian cancer is a highly dangerous disease, and many patients lose their lives due to limited treatment effectiveness. Previous studies have shown that current immunotherapy (e.g., PD-1 inhibitors) has poor results in ovarian cancer. The research team discovered that adding "heated abdominal chemotherapy" (called HIPEC, which uses a heated drug solution to wash the abdomen) to standard chemotherapy helps patients better control tumors. Recent lab studies also found that HIPEC not only reduces "harmful cells" around tumors that block drug effectiveness but also makes immunotherapy drugs work better. Animal experiments further confirmed that combining HIPEC with immunotherapy improves outcomes. Therefore, the investigators aim to test a key question: Can HIPEC help immunotherapy drugs work more effectively in humans? Study Details: The study will conduct a small two-phase trial, planning to enroll 30 patients with advanced ovarian cancer (Stage IIIc-IVA). All participants will receive standard chemotherapy (paclitaxel + platinum drugs) combined with HIPEC and an immunotherapy drug (tislelizumab, a PD-1 inhibitor). The main goal is to check whether tumors are completely removed after surgery. Investigators will also track how long tumors stay under control, overall survival time, treatment safety, and use blood and tumor tissue tests to find biomarkers that predict treatment response. Why This Matters: The study hopes to identify a safe method to enhance immunotherapy effectiveness and offer improved outcomes for advanced ovarian cancer patients.
Phase:
PHASE2
Details
Lead Sponsor:
Jing Li