Epithelial ovarian cancer
Conditions
Interventions
Test group (ARM 2): QL 1706+bevacizumab.:Paclitaxel 175 mg/m^2 Q3W (Day 1) + Carboplatin (AUC=5) Q3W (Day 1) +/- Bevacizumab 15 mg/kg Q3W, planned for 6 cycles.
Control group (Arm 1): Paclitaxel+Carboplatin for 6 cycles.:QL1706 5 mg/kg Q3W (Day 1) + Bevacizumab 15 mg/kg Q3W (Day 1) (QL1706 monotherapy in Cycle 1, with bevacizumab added in combination starting
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation with a signed written informed consent form. 2. Female participants aged >=18 and = 1.5 × 10^9/L (1,500/mm^3); 2) Platelet count >= 100 × 10^9/L (100,000/mm^3); 3) Hemoglobin >= 90 g/L. (2) Renal: 1) Calculated creatinine clearance (CrCl) >= 50 mL/min, determined by the Cockcroft–Gault equation: CrCl (mL/min) = [(140 - age) × weight (kg) × F] / [SCr (mg/dL) × 72], where F = 0.85 for females and SCr is serum creatinine; 2) Urine protein 1 year; (2) Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy); (3) Serum FSH, LH, and plasma estradiol levels within the site laboratory’s postmenopausal range. 10. Willing and able to comply with the protocol-specified schedule of visits, treatment plan, laboratory assessments, and other study requirements. 11. Willing to complete quality-of-life questionnaires during treatment and follow-up, and to allow the questionnaire data to be used for clinical research purposes.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed ovarian malignancies other than ovarian clear cell carcinoma (OCCC), including other epithelial ovarian cancers and non-epithelial ovarian tumors, as well as ovarian tumors of low malignant potential (e.g., borderline tumors); 2. Any prior preoperative systemic antitumor therapy for the current OCCC, including but not limited to neoadjuvant chemotherapy (NACT) or other neoadjuvant approaches, or planned receipt of neoadjuvant therapy during screening followed by interval debulking surgery (IDS); 3. Prior treatment with immune checkpoint inhibitors (anti–PD-1/PD-L1), agents targeting other T-cell receptors (e.g., CTLA-4), immune checkpoint agonistic antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40), or any immune cell therapy; 4. Systemic use of corticosteroids or other immunosuppressive agents (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors) within 2 weeks before first dosing; Note: Inhaled or topical steroids, steroids used as premedication for hypersensitivity reactions (e.g., CT scan contrast premedication, cytotoxic chemotherapy premedication), or adrenal replacement steroids (3 years after curative surgery. 6. Contraindications to bevacizumab, including but not limited to a history of gastrointestinal perforation, major surgery within 28 days prior to treatment initiation or incompletely healed wounds, severe bleeding or recent hemoptysis, or any other condition deemed by the investigator to make bevacizumab inappropriate. 7. Receipt of a live attenuated vaccine within 30 days prior to first dose (and until 90 days after the last dose of study treatment). Note: Live vaccines include, but are not limited to, measles, mumps, rubella, varicella/zoster, yellow fever, rabies, bacillus Calmette–Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines not containing live virus and inactivated COVID-19 vaccines are permitted. 8. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to first dosing. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment. Note: Patients with cataracts, Graves' disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. 9. A systemic infection requiring systemic antibiotic therapy within 2 weeks prior to randomization, or other serious infection; or unexplained fever >38.0°C during screening or prior to enrollment; and inability to discontinue aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 5 days. 10. Severe disease or significant non-malignant comorbidities (e.g., neurologic disorders, psychiatric illness, infectious diseases, or laboratory abnormalities) that may increase the risk of study participation or study drug administration, and that, in the investigator’s judgment, make the patient unsuitable for the study. 11. Pregnancy or lac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Time from randomization to second disease progression or death;Time to First Subsequent Therapy ;Time to Second Subsequent Therapy;Quality of Life (QoL) assessment in patients with ovarian clear cell carcinoma after treatment; | — |
Countries
China
Contacts
Public ContactGao Qinglei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed