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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
surgery/chemotherapy
Procedure/Surgerysecondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy
Iparomlimab/Tuvonralimab
DrugIparomlimab/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.
Treatment groups
33 Participants
are divided into 3 treatment groupsGroup A: criteria-fulfilled armExperimental treatment 2 interventions
Group B: compassionate use armExperimental treatment 2 interventions
Group C: real world armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival in CF arm
The time from entry into the study to the diagnosis of the first progression or recurrence or death in CF arm, whichever occurs first
Time frame
Up to 3 years2
3-years Overall Survival Rate in CF arm
The proportion of patients without death at 3 years after entry into the study in CF arm
Time frame
Up to 3 yearsSecondary outcomes
1
Overall survival in CF arm
The time from entry into the study to the date of death from any cause or last follow-up in CF arm
Time frame
Up to 3 years2
TFST in CF arm
Time from entry into the study until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first, in CF arm
Time frame
Up to 3 years3
TSST in CF arm
Time from entry into the study until the starting date of the second subsequent anticancer therapy or death, whichever occurred first, in CF arm
Time frame
Up to 3 years4
Post-operative complications in CF and CU arms
The surgical complications will be evaluated at 30-day after secondary cytoreductive surgery in CF and CU arms
Time frame
Up to 1 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Gynecologic Oncology Group
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Tongji Hospital
Collaborator
Source ClinicalTrials.gov
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