Status:

NOT_YET_RECRUITING

Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients

Lead Sponsor:

Fudan University

Conditions:

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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)...

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 perfusio...

Eligibility Criteria

Inclusion

  • 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;

Exclusion

  • 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.

Key Trial Info

Start Date :

August 31 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT06544460

Start Date

August 31 2024

End Date

December 31 2026

Last Update

August 9 2024

Active Locations (1)

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Fudan university shanghai cancer center, Deparment of gynecologic oncology

Shanghai, Shanghai Municipality, China, 200032