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

Condition(s) studied

Investigational drug(s) / intervention(s)

ICI-HIPET: Patients received the following interventions: On Day 0, intravenous administration of tislelizumab (an anti-PD-1 immune checkpoint inhibitor) was initiated within 3 hours post-HIPEC. Tumor tissue samples were collected before HIPEC, at 30 minutes, 60 minutes, and 90 minutes (end of HIPEC). Serum samples were collected pre- and post-HIPEC. On Day 1, additional serum samples were collected 24 hours after HIPEC-ICI completion. From Days 2-3, patients underwent paclitaxel + carboplatin chemotherapy, with serum sampling repeated at 48 hours post-HIPEC-ICI. On Days 21 and 42, the second and third cycles of neoadjuvant chemotherapy (tislelizumab + paclitaxel + carboplatin) were administered intravenously.

Study 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.

Eligibility

Primary outcome measure(s)

• R0 Resection Rate — At interval debulking surgery (approximately 9-12 weeks after treatment initiation)
  R0 resection rate refers to the proportion of patients achieving complete macroscopic tumor removal (no visible residual disease) during interval debulking surgery after three cycles of neoadjuvant chemotherapy. This is determined by the surgeon's intraoperative assessment of the pelvic and abdominal cavities for any gross residual lesions.

Trial sites (1)

Other trials for the same condition