Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients

Phase 2

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Procedure: Secondary cytoreduction; Drug: Hyperthermic intraperitoneal chemotherapy

• Registration Number: NCT06544460
• Lead Sponsor: Fudan University

Brief Summary

At present, the treatment of recurrent ovarian cancer after PARP inhibitor therapy is quite challenging, and there is no research on the application of hyperthermic intraperitoneal chemotherapy(HIPEC) for the above-mentioned patients. Therefore, this study aims to explore the safety and efficacy of secondary cytoreduction combined with hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer after maintenance therapy with PARP inhibitors through a single-center, prospective, single-arm, phase II clinical trial. The goal is to explore the treatment options for ovarian cancer patients in the era of PARP inhibitors, thereby improving the overall treatment level and prognosis of ovarian cancer.

Detailed Description

1. Overall design This is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for recurrent ovarian cancer after maintenance therapy with PARP inhibitors.

2. Sample size calculation This clinical trial aims to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for the maintenance treatment of recurrent ovarian cancer with PARP inhibitors. The median progression-free survival of patients who received maintenance therapy with PARP inhibitors in our center is 11 months. It is expected that HIPEC can reduce the risk of recurrence by 30%. After 1 year of enrollment and 2 years of follow-up, the alpha value is 0.05. Considering the participants who withdrew from the study midway or dropped out due to loss to follow-up, this study intends to include 94 participants.

3. Methods Using the BR-TQR-I intraperitoneal hyperthermic perfusion chemotherapy instrument, after the surgical operation is completed, four drainage tubes are placed in the left and right upper abdomen and lower abdomen respectively. Connect all pipelines and preheat the instrument before starting treatment. The treatment temperature is controlled at 43 ℃± 0.1 ℃, the treatment time is 90 minutes, and the circulation pump flow rate is 400-600ml/min. Within 48 hours after the surgery, cisplatin 75mg/㎡ was added to 3000ml of physiological saline for intraperitoneal hot infusion.

4. Data statistics Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.

Study Timeline

• Study First Submitted: 2024-07-29
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-08-31
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

1. Patients with previously diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
2. Maintain treatment with PARP inhibitors before recurrence;
3. The imaging assessment is suitable, and the patient agrees to undergo further cytoreductive surgery;
4. The outcome of recurrent surgery is R0 or R1 resection;
5. Sign the informed consent form;
6. Age≥18 years old;

Exclusion Criteria

1. Patients with ovarian cancer excluded by pathological or clinical diagnosis;
2. Inappropriate imaging evaluation or physical intolerance for surgical patients;
3. Isolated lymph node recurrence
4. Patients who undergo unsatisfactory tumor reduction surgery (R2 resection) due to recurrence;
5. Patients who are unwilling to participate in the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recurrent Ovarian Cancer After PARPi Therapy	Hyperthermic intraperitoneal chemotherapy	After treated with PARP inhibitors, patients have recurrent ovarian cancer and need a surgery.
Recurrent Ovarian Cancer After PARPi Therapy	Secondary cytoreduction	After treated with PARP inhibitors, patients have recurrent ovarian cancer and need a surgery.

Primary Outcome Measures

Name	Time	Method
PFS	Two years	Progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	Two years	Overall Survival

Trial Locations

Locations (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology; 🇨🇳 Shanghai, Shanghai, China