INVIGORATE: A Study of QL1706 and Bevacizumab in Advanced First-Line Ovarian Clear Cell Carcinoma
Status:
NOT_YET_RECRUITING
Trial end date:
2029-06-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn if QL1706 combined with bevacizumab can effectively treat adult female patients (18 to \<75 years old) with newly diagnosed FIGO stage IC-IV advanced ovarian clear cell carcinoma. The main questions it aims to answer are:
1. Does QL1706 combined with bevacizumab, compared to platinum-based chemotherapy, prolong patients' progression-free survival (PFS)?
2. What is the safety profile of QL1706 combined with bevacizumab, such as what medical problems (adverse events) do participants experience?
Researchers will compare QL1706 combined with bevacizumab (experimental arm) to a standard chemotherapy regimen of paclitaxel plus carboplatin (control arm) to see if QL1706 combined with bevacizumab is more effective in the first-line treatment of advanced ovarian clear cell carcinoma.
Participants will:
1. Be randomly assigned to receive either QL1706 combined with bevacizumab (QL1706 administered every 3 weeks, bevacizumab administered every 3 weeks) or paclitaxel plus carboplatin chemotherapy (administered every 3 weeks).
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.
Phase:
PHASE3
Details
Lead Sponsor:
Tongji Hospital
Collaborators:
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center Chinese Academy of Medical Sciences First Affiliated Hospital of Zhejiang University First Affiliated Hospital, Sun Yat-Sen University Fudan University Henan Cancer Hospital Henan Provincial People's Hospital Hubei Cancer Hospital Jiangsu Cancer Institute & Hospital Peking Union Medical College Hospital Peking University Cancer Hospital & Institute Peking University People's Hospital Renmin Hospital of Wuhan University Second Affiliated Hospital, School of Medicine, Zhejiang University Shanghai First Maternity and Infant Hospital Sir Run Run Shaw Hospital Sun Yat-sen University Cancer Center (SUSUCC) The First Affiliated Hospital of Zhengzhou University The International Peace Maternity & Child Health Hospital of China welfare institute The Second Affiliated Hospital, Sun Yat-sen University Third Affiliated Hospital of Zhengzhou University Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Women's Hospital School Of Medicine Zhejiang University Wuhan Central Hospital Zhejiang Cancer Hospital Zhejiang Provincial People's Hospital