Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients

NCT06544460 | Not Yet Recruiting Phase 2

• 1 other identifier: OCR-HIPEC-2024
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; hyperthermic intraperitoneal chemotherapy; secondary cytoreduction

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  Two years

Secondary Outcomes (1)

• OS

  Two years

Study Arms (1)

Recurrent Ovarian Cancer After PARPi Therapy

EXPERIMENTAL

After treated with PARP inhibitors, patients have recurrent ovarian cancer and need a surgery.

Procedure: Secondary cytoreduction; Drug: Hyperthermic intraperitoneal chemotherapy

Interventions

Secondary cytoreduction PROCEDURE

Repeated tumor cell reduction surgery for recurrent ovarian cancer patients

Recurrent Ovarian Cancer After PARPi Therapy

Hyperthermic intraperitoneal chemotherapy DRUG

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.

Recurrent Ovarian Cancer After PARPi Therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Central Study Contacts

Hao Wen

CONTACT

+86-021-64175590; wenhao@shca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecological Oncology

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 9, 2024
• Study Start: August 31, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)