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This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1316 Group | Experimental |
| |
| SHR-1316 Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1316 Injection | Drug | SHR-1316 injection. |
| |
| Cisplatin Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Up to approximately 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. | Up to approximately 60 months. |
| 3-year overall survival (OS) rate | OS rate within 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoxu Zhang | Contact | +86-0518-82342973 | xiaoxu.zhang@hengrui.com | |
| Zhaoyu Zhong | Contact | +86-0518-82342973 | zhaoyu.zhong.zz8@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Drug |
Cisplatin injection. |
|
| Carboplatin Injection | Drug | Carboplatin injection. |
|
| Paclitaxel Injection | Drug | Paclitaxel injection. |
|
| SHR-1316 Placebo Injection | Drug | SHR-1316 placebo injection. |
|
| Up to approximately 60 months. |
| 2-year progression-free survival (PFS) | PFS within 2 years. | Up to approximately 24 months. |
| Objective Response Rate (ORR) | Up to approximately 36 months. |
| Duration of response (DoR) | Up to approximately 60 months. |
| Local recurrence rate | Up to approximately 36 months. |
| Distant metastasis rate | Up to approximately 60 months. |
| The second disease progression assessed by the investigator | Up to approximately 60 months. |
| Adverse events (AEs) including incidence and grade correlation with study drugs | Up to approximately 60 months. |
| Rate of suspension and discontinuation due to an adverse event correlation with study drugs | Up to approximately 60 months. |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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