Surgery for Relapsed Ovarian Cancer in Precision

Sponsor
Shanghai Gynecologic Oncology Group
Study ID
NCT06602063
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • surgery/chemotherapy — PROCEDURE
    secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy
  • Iparomlimab/Tuvonralimab — DRUG
    Iparomlimab/tuvonralimab will be administered at a dose of 5 mg per kilogram IV every 21 days. Treatment will continue until disease progression confirmed by RECIST criteria v1.1, intolerable toxicity or withdrawal of consent.

Study Details

This multicenter, biomarker-driven, patient-centric study aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with anti-PD1/CTLA-4 bispecifics therapy in patients with platinum-sensitive relapsed ovarian cancer (PSROC).

Key Dates

First listed
Sep 19, 2024
Start date
Jul 31, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
33 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: criteria-fulfilled arm
    Patients who meet the inclusion and exclusion criteria will receive secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy with Iparomlimab/tuvonralimab maintenance therapy.
  • Experimental: compassionate use arm
    Patients who are enrolled under expanded eligibility criteria will receive secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy with Iparomlimab/tuvonralimab maintenance therapy.
  • No Intervention: real world arm
    Patients who meet the inclusion and exclusion criteria but refuse to participate in the CF and CU arms will receive the physician's therapy of choice.

Primary Outcome Measure

Progression-free survival in CF arm [ Time Frame: Up to 3 years ]

Central Contacts

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