NCT07068178Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Jun 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 May 2029
- Lead sponsor
- Jing Li
- Diseases
- Ovarian cancer
- NCT number
- NCT07068178
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 Aug 2025 to the primary completion date, 31 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior immunotherapy (including cellular therapy) or use of immunomodulators.
- Prior pelvic/abdominal radiotherapy.
- Prior hyperthermic intraperitoneal chemotherapy (HIPEC) or thermotherapy.
Other illness
- Intestinal fistula of any grade.
- History of organ transplantation.
- Inflammatory bowel disease.
- Active or history of autoimmune diseases (e.g., systemic lupus erythematosus).
- Grade ≥3 venous thromboembolism.
- Active infections (e.g., tuberculosis).
- 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.
Other
- Partial or complete bowel obstruction.
- Hydronephrosis unrelieved by ureteral stenting.
- Brain metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.