Status:
NOT_YET_RECRUITING
Surgery for Relapsed Ovarian Cancer in Precision
Lead Sponsor:
Shanghai Gynecologic Oncology Group
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Tongji Hospital
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 bispecif...
Detailed Description
The immune phenotype of patients with relapsed ovarian cancer may correlate with their response to immunotherapy. This multicenter, biomarker-driven, patient-centric study aimed to evaluate the effica...
Eligibility Criteria
Inclusion
- 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.
- BRCA1/2 wild type (both germline and somatic)
- Homologous Recombination Deficiency (HRD) is available
- Patients must provide archived or fresh tumor tissue samples for biomarker detection.
- PD-L1 positive (if either at least 1% of assessed tumour cells expressed membranous PD-L1, at least 5% of immune cells within the tumour area expressed PD-L1, or both) and number of intraepithelial CD8+ tumor-infiltrating lymphocytes (TILs) per high-powered field ≥ 6.
- Assessed by the experienced surgeons, complete resection of all recurrent disease is possible (predicted by iMODEL score or by PET/CT).
- ECOG performance status of 0 to 2
- Adequate bone marrow, liver, and renal function to receive combined immunotherapy
- Written informed consent
- Arm 2 (compassionate use, CU), Similar to cohort 1, except for:
- If the patient had previous PARPi maintenance therapy, disease progression should occurring within 3 months after the prior PARPi withdrawal or during the PARPi maintenance therapy.
- PD-L1 positive or number of intraepithelial CD8+ TILs per high-powered field ≥ 6.
- Arm 3 (real word) Patients who meet the inclusion criteria but refuse to participate in the phase II CF and CU cohorts.
Exclusion
- 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
- Patients have been vaccinated with the live vaccine or received anti-tumor treatment within 4 weeks before the first administration.
- Synchronous or metachronous (within 5 years) malignancy, symptomatic or uncontrolled visceral metastases that require simultaneous treatment, other than carcinoma in situ or breast cancer (without any signs of relapse or activity).
- Patients with parenchymal metastases and life-threatening complications in short term.
- Any other concurrent medical conditions contraindicating surgery, chemotherapy, or immunotherapy that could compromise the adherence to the protocol.
- Patients are known to be allergic to the active ingredients or excipients of Sintilimab.
- HRD status is not available.
- Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents or bevacizumab.
- Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.
- Impossible to assess the resectability of recurrent disease or evaluate the score. Radiological signs suggesting complete resection is impossible.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06602063
Start Date
July 1 2025
End Date
June 1 2030
Last Update
June 27 2025
Active Locations (2)
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1
Zhongshan Hospital Fudan University
Shanghai, China
2
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China