The goal of this phase 3 clinical trial is to evaluate whether QL1706 plus bevacizumab can effectively treat adult female patients (18 to \<75 years old) with newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma. The main questions it aims to answer are:
1. Does QL1706 plus bevacizumab, compared with standard platinum-based chemotherapy with or without bevacizumab, prolong patients' progression-free survival (PFS)? 2. What is the safety profile of QL1706 followed by QL1706 plus bevacizumab, such as what medical problems (adverse events) do participants experience?
Researchers will compare QL1706 followed by QL1706 plus bevacizumab (experimental arm) with standard platinum-based chemotherapy consisting of paclitaxel plus carboplatin with or without bevacizumab (control arm) to see whether QL1706-based immunotherapy is more effective in the first-line treatment of advanced ovarian clear cell carcinoma.
Participants will:
1. Be randomly assigned to receive either QL1706 alone during Cycle 1 followed by QL1706 plus bevacizumab from Cycle 2, or paclitaxel plus carboplatin with or without bevacizumab according to prespecified high-risk criteria. 2. Visit the research center regularly for drug infusions, medical examinations (such as vital signs, physical exams, laboratory tests), and tumor imaging assessments. 3. Complete quality of life questionnaires as required.
Voluntary participation in the study and signed informed consent form.
Age ≥ 18 years and < 75 years, female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Expected survival ≥ 3 months.
Histologically confirmed ovarian cancer of other epithelial origin or non-epithelial origin, other than ovarian clear cell carcinoma; ovarian tumors of low malignant potential, such as borderline tumors.
Prior systemic preoperative antitumor therapy for the current ovarian clear cell carcinoma, including but not limited to neoadjuvant chemotherapy (NACT) or other types of neoadjuvant therapy, or planned neoadjuvant therapy followed by interval debulking surgery (IDS) during screening.
Prior treatment with immune checkpoint inhibitors, such as PD-1/PD-L1 antibodies, or drugs targeting other T-cell receptors, such as CTLA-4, as well as immune checkpoint agonist antibodies, such as anti-ICOS, CD40, CD137, GITR, or OX40 antibodies, and immune cell therapy.
Systemic use of corticosteroids or other immunosuppressive drugs, such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or TNFα inhibitors, within 2 weeks before the first dose. Note: Inhaled or topical steroids, steroids as premedication for hypersensitivity reactions, such as CT scan contrast agent premedication or cytotoxic chemotherapy premedication, or adrenal replacement steroids, daily ≤10 mg prednisone or equivalent, are permitted in the absence of active autoimmune disease.
Tongji Hospital
Lead sponsor
Chinese Academy of Medical Sciences
Collaborator
Peking Union Medical College Hospital
Collaborator
Fudan University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Peking University People's Hospital
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
The Second Affiliated Hospital, Sun Yat-sen University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
Hubei Cancer Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Wuhan Central Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Third Affiliated Hospital of Zhengzhou University
Collaborator
Henan Provincial People's Hospital
Collaborator
Henan Cancer Hospital
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
The International Peace Maternity & Child Health Hospital of China welfare institute
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator