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| Name | Class |
|---|---|
| Affiliated Hospital of North Sichuan Medical College | OTHER |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
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This study will evaluate the efficacy and safety of concurrent chemoradiotherapy(CCRT)followed by cadonilimab(AK104) in high risk local advanced cervical cancer.
Participants received CCRT,efficacy evaluation of CCRT was no disease progression who maintained with AK104(10.0 mg/kg,Q3W)until drug exposure over 1 years or disease progression or intolerable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | AK104(10.0 mg/kg,intravenous (IV) infusion,Q3W) after CCRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | AK104(10.0 mg/kg,intravenous (IV) infusion,Q3W)maintained with no more than 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first. | Baseline up to approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate assessed by Investigator | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1. | Baseline up to approximately 12 months. |
| Disease control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rutie Yin, Clinical Professor | Contact | yrtt2013@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
| Baseline up to approximately 12 months. |
| Overall survival | OS is the time from randomization to death due to any cause | Baseline up to approximately 48 months. |
| Safety and adverse reactions of Cadonilimab | According to CTCAE v5.0, any adverse events that occur to all subjects during the study period will be recorded. We recorded the clinical manifestation characteristics, severity, onset time, duration, treatment method and prognosis, and determined the correlation with Cadonilimab. | Baseline up to approximately 48 months. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |