NCT06544460Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 9 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 31 Aug 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Fudan University
- Diseases
- Ovarian cancer
- NCT number
- NCT06544460
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 94
- From 31 Aug 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inappropriate imaging evaluation or physical intolerance for surgical patients;
- Patients who undergo unsatisfactory tumor reduction surgery (R2 resection) due to recurrence;
Other illness
- Patients with ovarian cancer excluded by pathological or clinical diagnosis;
Other
- Isolated lymph node recurrence
- Patients who are unwilling to participate in the clinical trial.
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan university shanghai cancer center, Deparment of gynecologic oncology Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.