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

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.

Sex

Female

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

* Diagnosed with FIGO stage IIIC-IVA high-grade serous ovarian adenocarcinoma (histologically confirmed).
* Aged 18-70 years.
* Life expectancy ≥12 months.
* CT Suidan score ≥7 and Fagotti score ≥8 (assessed by two independent gynecologic oncologists via laparoscopic evaluation).
* Adequate organ function:AST/ALT ≤2× upper limit of normal (ULN);Total bilirubin ≤1.5× ULN;Serum creatinine ≤1.5× ULN.
* No myelosuppression:Hemoglobin (Hb) ≥80 g/L,White blood cell count (WBC) ≥2.0×10⁹/L,Neutrophil count ≥1.0×10⁹/L,Platelet count ≥100×10⁹/L.
* Performance Status (PS) score 0-1.

Exclusion Criteria:(Excluded if any criterion is met)

* Partial or complete bowel obstruction.
* Intestinal fistula of any grade.
* Hydronephrosis unrelieved by ureteral stenting.
* History of organ transplantation.
* Inflammatory bowel disease.
* Active or history of autoimmune diseases (e.g., systemic lupus erythematosus).
* Prior immunotherapy (including cellular therapy) or use of immunomodulators.
* Brain metastases.
* Grade ≥3 venous thromboembolism.
* Active infections (e.g., tuberculosis).
* Prior pelvic/abdominal radiotherapy.
* Prior hyperthermic intraperitoneal chemotherapy (HIPEC) or thermotherapy.
* Grade ≥2 dysfunction of major organs (e.g., heart, liver, kidneys).
* Other malignancies within 5 years (except skin or thyroid cancer).
* Psychiatric disorders affecting compliance.