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

No results posted yet for this study

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

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

Sponsors & Collaborators

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06123884 on ClinicalTrials.gov