NCT06544460

Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients

Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer Patients With PARP Inhibitors Resistance: a Phase II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
PROCEDURE	Secondary cytoreduction	Repeated tumor cell reduction surgery for recurrent ovarian cancer patients
DRUG	Hyperthermic intraperitoneal chemotherapy	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. Through the comprehensive effects of circulation flushing, hyperthermia, chemotherapy, and thermochemotherapy sensitization, it kills and removes residual cancer cells or small lesions in the abdominal cavity.

Timeline

• Start date: 2024-08-31
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: China