Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients

NCT06544460 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Phase 2

Started

2024-08-31

Last updated

2024-08-09

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Secondary cytoreductionHyperthermic intraperitoneal chemotherapy

Secondary cytoreduction: Repeated tumor cell reduction surgery for recurrent ovarian cancer patients

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.

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

PFS — Two years
Progression free survival

Trial sites (1)

Facility	City	Region	Status
Fudan university shanghai cancer center, Deparment of gynecologic oncology	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06544460 on ClinicalTrials.gov ↗ ← All trials in China