BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer
NCT06123884 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 526
Last updated 2025-02-10
Summary
Phase II study: a study to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab Phase III study: a confirmatory study to evaluate the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer
Conditions
Interventions
- DRUG
-
Recombinant humanized anti-PD-1 monoclonal antibody injection
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).
- DRUG
-
the usage and dosage should be determined by the investigator
- DRUG
-
Bevacizumab Injection
Strength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks (15 mg/kg, Q3W)
- DRUG
-
the usage and dosage should be determined by the investigator
- DRUG
-
Paclitaxel for Injection
the usage and dosage should be determined by the investigator
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Qinglei Gao, Ph.D · Tongji Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-13
- Primary Completion
- 2026-09-30
- Completion
- 2027-01-31
Countries
- China
Study Locations
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