A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
NCT ID: NCT05235516
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
636 participants
INTERVENTIONAL
2022-06-21
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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treatment arm
AK104
q3w iv
EBRT
45-50.4Gy
BT
≥80Gy
cisplatin
qw iv
placebo arm
EBRT
45-50.4Gy
BT
≥80Gy
cisplatin
qw iv
Placebo
q3w iv
Interventions
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AK104
q3w iv
EBRT
45-50.4Gy
BT
≥80Gy
cisplatin
qw iv
Placebo
q3w iv
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Principal Investigators
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Jihong Liu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Yang Xiang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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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
Countries
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Other Identifiers
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AK104- 305
Identifier Type: -
Identifier Source: org_study_id
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