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RECRUITING
NCT06123884
PHASE2/PHASE3

BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer

Sponsor: Bio-Thera Solutions

View on ClinicalTrials.gov

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

Official title: A Phase II/III 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

526

Start Date

2023-12-13

Completion Date

2027-01

Last Updated

2025-02-10

Healthy Volunteers

No

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

Cisplatin

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

carboplatin

the usage and dosage should be determined by the investigator

DRUG

Paclitaxel for Injection

the usage and dosage should be determined by the investigator

Locations (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China