Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients

August 7, 2024 updated by: Xiaohua Wu MD [zzhong], Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan university shanghai cancer center, Deparment of gynecologic oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recurrent Ovarian Cancer After PARPi Therapy
After treated with PARP inhibitors, patients have recurrent ovarian cancer and need a surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Two years
Progression free survival
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: Two years
Overall Survival
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCR-HIPEC-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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