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ACTIVE NOT RECRUITING
NCT05235516
PHASE3

A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer

Sponsor: Akeso

View on ClinicalTrials.gov

Summary

This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

636

Start Date

2022-06-21

Completion Date

2029-05

Last Updated

2024-08-13

Healthy Volunteers

No

Interventions

DRUG

AK104

q3w iv

RADIATION

EBRT

45-50.4Gy

RADIATION

BT

≥80Gy

DRUG

cisplatin

qw iv

DRUG

Placebo

q3w iv

Locations (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Guizhou Cancer Hospital

Guiyang, Guizhou, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Hunan cancer hospital

Changsha, Hunan, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China Second University Hospital

Chengdu, Sichuan, China

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China