Ovarian cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab combined with PARP inhibitor and bevacizumab
Control group:PARP inhibitor plus bevacizumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years and =6 months. 5.Progression-free interval (PFI) >=12 months. 6.At least one measurable, untreated lesion. 7.ECOG Performance Status (ECOG PS) 0-1. 8.American Society of Anesthesiologists (ASA) Physical Status Classification 1-2. 9.Adequate major organ function with laboratory values meeting the following requirements: (1) Hemoglobin (Hb) >=90 g/L; (2) Absolute neutrophil count (ANC) >=1.5×10^9/L; (3) Platelet count (PLT) >=100×10^9/L; (4) Total bilirubin (TBIL) =60 mL/min (per Cockcroft-Gault formula); (7) Coagulation function: International normalized ratio (INR) =12 months of spontaneous amenorrhea with no alternative cause), and has not undergone surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). 11.Ability to comply with the study protocol and attend follow-up visits as scheduled. 12.Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Non-epithelial ovarian cancer, borderline tumors, mucinous ovarian carcinoma, or low-grade tumors. 2.Preoperative imaging indicating multiple unresectable metastases in liver or lung parenchyma, extensive mediastinal lymph node metastases, extensive pleural metastases, brain metastases, or bone metastases. 3.Prior immunotherapy, including immune checkpoint inhibitor antibodies (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, etc.), immune checkpoint agonist antibodies (e.g., anti-ICOS, anti-CD40, anti-CD137, anti-GITR, anti-OX40 antibodies, etc.), and cellular immunotherapy. 4.General condition not permitting complete surgical resection; comorbidities rendering patient unsuitable for surgery or chemotherapy. 5.Known hypersensitivity to PARP inhibitors, PD-1 antibodies, CTLA-4 antibodies, or active/inactive ingredients with similar chemical structure. 6.Concurrent or other malignancies within 5 years that are not controlled, except for carcinoma in situ and breast cancer without active disease or recurrence. 7.Major surgery within 28 days before first dose (diagnostic laparoscopy excluded; local treatment of isolated lesions is acceptable). 8.History of allogeneic tissue/solid organ transplantation. 9.Within 2 weeks before first dose, conditions requiring systemic corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive drugs (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.). Topical, nasal, and inhaled corticosteroids are permitted. Systemic corticosteroids for contrast allergy prophylaxis are permitted. 10.Active or potentially recurrent autoimmune disease, except for: vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy; hypothyroidism from autoimmune thyroiditis requiring only stable-dose hormone replacement; Type I diabetes requiring only stable-dose insulin replacement. 11.History of interstitial lung disease and/or pneumonitis, or pulmonary hypertension. 12.Active infection requiring systemic therapy. 13.Symptomatic, untreated brain metastases or leptomeningeal metastases that have not achieved clinical stability. 14.Poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) and diabetes despite standard therapy; uncontrolled or symptomatic arrhythmia. 15.Thrombotic or embolic events within 6 months before study treatment initiation, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or pulmonary embolism. 16.Myocardial infarction within past 12 months, severe/unstable angina, or symptomatic congestive heart failure (NYHA Class III or IV). 17.Severe, unhealed, or dehisced wounds, active ulcers, or untreated fractures. 18.Known active HIV, HBV, or HCV infection. 19.Other conditions (religious, psychological, etc.) affecting ability to provide informed consent, comply with study protocol, or attend follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to First Subsequent Therapy;Time to Second Subsequent Therapy;Overall survival;Health-related quality of life, HRQoL;Safety; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center
Outcome results
None listed