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

NCT07068178 | Not Yet Recruiting Phase 2

• 1 other identifier: ICI-HIPET
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIPEC; Ovarian Serous Adenocarcinoma

Keywords

ICI-HIPET

Outcome Measures

Primary Outcomes (1)

• R0 Resection Rate

  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.

  At interval debulking surgery (approximately 9-12 weeks after treatment initiation)

Secondary Outcomes (4)

• Rate of progression-free survival

  From day 1 of treatment until progression/death, through study completion (up to 24months)

• Rate of overall survival

  From completion of first neoadjuvant therapy until death from any cause, assessed up to 24 months

• Pathological response rate

  During pathological examination of omental tissue (within 2 weeks post-surgery)

• Radiological Response Rate

  After 3 cycles of neoadjuvant therapy (approximately 9 weeks)

Other Outcomes (1)

• Adverse Event (AE) Incidence

  up to 24 months

Study Arms (1)

ICI-HIPET

EXPERIMENTAL

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.

Drug: ICI-HIPET

Interventions

ICI-HIPET DRUG

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.

ICI-HIPET

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing Li: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Central Study Contacts

Jing Li, Doctor

CONTACT

+86 17701927439; lijing228@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 16, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)