NCT07514494 Intensification Treatment of Ovarian Cancer by PIPAC
| NCT ID | NCT07514494 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Moscow Regional Oncological Dispensary |
| Condition | Advanced Epithelial Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-04-02 |
| Primary Completion | 2026-10-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2025-04-02 with a primary completion date of 2026-10-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn whether repeated cisplatin-based PIPAC added to standard TC chemotherapy can improve outcomes in women aged 18-75 years with newly diagnosed FIGO IIIB-IIIC epithelial ovarian cancer and visually detectable peritoneal carcinomatosis. The main questions are whether repeated PIPAC increases the rate of complete surgical cytoreduction (CRS R0) and whether it improves disease control, survival outcomes, and safety compared with standard combined treatment including a single PIPAC procedure. Participants will undergo screening, intraoperative randomization, systemic chemotherapy, PIPAC procedures according to study arm, interval cytoreductive surgery, protocol-specified postoperative treatment if needed, and regular follow-up assessments.
Eligibility Criteria
Inclusion Criteria: * Female, age 18-75 years. * Histologically verified ovarian cancer with peritoneal carcinomatosis. * FIGO stage IIIB or IIIC. * visually detectable peritoneal carcinomatosis. * Peritoneal metastatic involvement documented preoperatively by ultrasound, CT, MRI, PET-CT, or equivalent imaging. * Ability to comply with protocol procedures and provide written informed consent. Exclusion Criteria: * Age \> 75 years; ECOG 3-4; cachexia with BMI \<= 16. * Severe concomitant disease in exacerbation or decompensation. * Extra-abdominal metastases, including metastatic pleuritis. * Mucinous ovarian carcinoma or another active malignant neoplasm, except malignancies in clinical remission for more than 2 years. * Pronounced adhesive disease of the abdominal cavity. * Pregnancy or breastfeeding. * Positive BRCA1 or BRCA2 status. * Any condition precluding safe PIPAC or protocol execution, including hollow-organ perforation, gastrointestinal resection with anastomosis, or repair of a hollow-viscus defect. * Refusal of treatment at any study stage.
Contact & Investigator
Alexey S. Dzasokhov, MD, PhD
PRINCIPAL INVESTIGATOR
Moscow Regional Oncological Dispensary
Frequently Asked Questions
Who can join the NCT07514494 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Advanced Epithelial Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07514494 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07514494 currently recruiting?
Yes, NCT07514494 is actively recruiting participants. Contact the research team at dzasokhov-pipac@mail.ru for enrollment information.
Where is the NCT07514494 trial being conducted?
This trial is being conducted at Balashikha, Russia.
Who is sponsoring the NCT07514494 clinical trial?
NCT07514494 is sponsored by Moscow Regional Oncological Dispensary. The principal investigator is Alexey S. Dzasokhov, MD, PhD at Moscow Regional Oncological Dispensary. The trial plans to enroll 160 participants.
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