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A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer | Clinical Trials | Clareo Health

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

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

NCT05235516•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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. signs the written informed consent form
•2. ECOG 0-1
•3. Life expectancy ≥ 3 months.
•4. The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
•5. Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
•6. At least one measurable tumor lesion per RECIST v1.1
•7. Adequate organ function as assessed in the laboratory tests

Exclusion Criteria

•1. Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
•2. FIGO 2018 IVB
•3. Subjects who had previously undergone total hysterectomy
•4. Subjects who cannot receive brachytherapy
•5. Subjects with other active malignancies within 2 years prior to randomization
•6. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
•7. Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PDL1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40,CD137, GITR, OX40 targets, etc).
•8. Subjects who require systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization;
•9. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
•10. Use of live vaccines within 4 weeks prior to randomization
+6 more criteria

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

Key Dates

Start Date

June 21, 2022

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2029

Last Updated

August 13, 2024

Enrollment

636

ESTIMATED participants

Conditions

Locally Advanced Cervical Carcinoma

Interventions

AK104

DRUG

EBRT

RADIATION

cisplatin

DRUG

Placebo

DRUG

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

NCT05975593

Locally Advanced Cervical CarcinomaLocally Advanced Cervical Cancer+8 more

View study

RECRUITINGNA

PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

NCT05406856

Uterine Cervical NeoplasmsLocally Advanced Cervical Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

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