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)
Progression-Free Survival(PFS) by investigator(INV) — 54 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 and/or biopsy
Trial sites (9)
Facility
City
Region
Status
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
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.
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