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Clinical Trials in China / NCT05235516
Active, not recruiting Phase 3

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

NCT05235516 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 3
Started
2022-06-21
Last updated
2024-08-13

Condition(s) studied

Locally Advanced Cervical Carcinoma

Investigational drug(s) / intervention(s)

AK104EBRTBTcisplatinPlacebo

AK104: q3w iv

EBRT: 45-50.4Gy

BT: ≥80Gy

cisplatin: qw iv

Placebo: q3w iv

Study 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

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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 11. Active or potentially recurrent autoimmune disease 12. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies 13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 14. Known history of interstitial lung disease or non-infectious pneumonitis 15. Pregnant or lactating women. 16. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality
Guizhou Cancer Hospital Guiyang Guizhou
Hubei Cancer Hospital Wuhan Hubei
Xiangya Hospital Central South University Changsha Hunan
Hunan cancer hospital Changsha Hunan
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
West China Second University Hospital Chengdu Sichuan
Women's Hospital School Of Medicine Zhejiang University Hangzhou Zhejiang
Zhejiang Cancer Hospital Hangzhou Zhejiang

More Akeso trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05235516 on ClinicalTrials.gov ↗ ← All trials in China