Surgery for Relapsed Ovarian Cancer in Precision
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorShanghai Gynecologic Oncology Group
About this trial
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).
Eligibility criteria
Qualifiers
Arm 1 (criteria-fulfilled, CF)
Age at recurrence ≥ 18 years, <80 years.
Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more.
If the patient had previous PARPi maintenance therapy, disease progression should occurring at lease 3 months after the prior PARPi withdrawal.
Disqualifiers
Patients with borderline, low-grade tumors, clear cell carcinoma, as well as non-epithelial tumors.
Patients with platinum-resistant or refractory diseases.
Lack of tumor samples (archived and/or recently obtained) for biomarker detection.
Previous administration of immunotherapy
Trial design
Treatments tested in this trial
- surgery/chemotherapy
- Iparomlimab/Tuvonralimab
Treatment groups
33 Participants
are divided into 3 treatment groupsSponsors and collaborators
Shanghai Gynecologic Oncology Group
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Tongji Hospital
Collaborator
Source ClinicalTrials.gov