Actively Recruiting
A Randomized Phase 3 Trial Comparing QL1706 Plus Bevacizumab Versus Standard Platinum-Based Chemotherapy With or Without Bevacizumab as First-Line Treatment for Advanced Ovarian Clear Cell Carcinoma
Led by Tongji Hospital · Updated on 2026-05-18
226
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
C
Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of QL1706 combined with bevacizumab to treat adult female patients aged 18 to under 75 years with newly diagnosed advanced ovarian clear cell carcinoma, specifically FIGO stage IC-IV. This phase 3 trial aims to determine if this combination can improve progression-free survival compared to standard platinum-based chemotherapy with or without bevacizumab. The study also assesses the safety and side effects experienced by participants during treatment. Participants are randomly assigned to one of two groups: the experimental arm receiving QL1706 alone during the first cycle followed by QL1706 plus bevacizumab from the second cycle, or the control arm receiving standard chemotherapy with paclitaxel and carboplatin, with or without bevacizumab based on risk factors. QL1706 is given intravenously every three weeks at 5 mg/kg for up to two years, while bevacizumab is administered every three weeks at 15 mg/kg for up to 22 cycles or until disease progression or intolerable side effects. Chemotherapy is given every three weeks for six cycles, with bevacizumab possibly continued as per criteria. Throughout the study, participants visit the research center regularly to receive infusions, undergo medical exams including vital signs, lab tests, and tumor imaging scans, and complete quality of life questionnaires. Researchers monitor outcomes such as progression-free survival over up to four years, overall survival, time to subsequent therapies, and treatment-related adverse events. The study includes ongoing safety evaluations and quality of life assessments during treatment and follow-up periods.
CONDITIONS
Brief Title
INVIGORATE: A Study of QL1706 and Bevacizumab in Advanced First-Line Ovarian Clear Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Female aged 18 to under 75 years
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma confirmed by pathology
- Planned primary debulking surgery with complete surgical records and residual disease assessment
- No prior first-line postoperative systemic antitumor therapy for current ovarian clear cell carcinoma
- Adequate organ function as defined by blood counts, kidney, liver, and coagulation parameters
- Negative pregnancy test and effective contraception use for women of childbearing potential
- Willing and able to comply with study visits, treatment, tests, and quality of life questionnaires
You will not qualify if you...
- Ovarian cancers other than clear cell carcinoma or low malignant potential tumors
- Prior systemic preoperative antitumor therapy or planned neoadjuvant therapy followed by interval debulking surgery
- Previous treatment with immune checkpoint inhibitors or immune cell therapies
- Recent systemic corticosteroids or immunosuppressive drug use within 2 weeks before study
- Malignancies within 5 years except certain cured local tumors
- Contraindications to bevacizumab such as recent surgery, severe bleeding, or gastrointestinal perforation
- Receipt of live vaccines within 30 days before first dose until 90 days after last dose
- Active autoimmune disease requiring systemic treatment within 2 years
- Recent severe infections or fever within 2 weeks before enrollment
- Significant non-tumor illnesses increasing study risk
- Pregnant or breastfeeding women
- Clinically significant cardiovascular diseases including recent heart attack, stroke, uncontrolled hypertension, or heart failure
- Expected need for other anti-tumor therapies during study
- Recent use of traditional Chinese medicines with antitumor effects or immunomodulatory drugs
- HIV positive status
- Active or recent tuberculosis or hepatitis B or C infection
- Pre-existing peripheral neuropathy grade 2 or higher
- Recent use of full-dose anticoagulants or thrombolytics within 10 days before first dose
- History of bleeding disorders, thrombosis, or tumor invasion of major blood vessels
- Severe allergies to study drugs or related components
- Participation in other interventional clinical trials or investigational treatments within 4 weeks
- Investigator judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or 22 cycles depending on treatment arm
Participants receive one of two treatment regimens: either QL1706 plus Bevacizumab intravenously every 3 weeks for up to 2 years or 22 cycles, or Paclitaxel plus Carboplatin intravenously every 3 weeks for up to 6 cycles with or without Bevacizumab according to risk, administered every 3 weeks for up to 22 cycles.
Intravenous treatments every 3 weeks during the treatment period
Duration - Up to 4 years
Participants are monitored for safety, disease progression, and survival outcomes after treatment ends, for up to 4 years.
Periodic visits during the follow-up period
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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