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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental |
| |
| placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | q3w iv |
| |
| EBRT |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival(PFS) by investigator(INV) | 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 | 54 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS rate at month 36 | PFS rate at month 36 | 36 months |
| Overall Survival(OS) | OS is defined as the time from randomization to death due to any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jihong Liu, Ph.D | Sun Yat-sen University | Principal Investigator |
| Yang Xiang, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100005 | China | ||
| Guizhou Cancer Hospital |
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| Radiation |
45-50.4Gy |
|
| BT | Radiation | ≥80Gy |
|
| cisplatin | Drug | qw iv |
|
| Placebo | Drug | q3w iv |
|
| 5 years |
| Guiyang |
| Guizhou |
| 550000 |
| China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410013 | China |
| Hunan cancer hospital | Changsha | Hunan | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| West China Second University Hospital | Chengdu | Sichuan | 610041 | China |
| Women's Hospital School Of Medicine Zhejiang University | Hangzhou | Zhejiang | 310005 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310005 | China |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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