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The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.
The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1316 plus concurrent chemoradiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1316 | Biological | SHR-1316(Adebrelimab Injection) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Type, incidence and grade of drug-related adverse events of grade 3 and above | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs | Up to approximately 30 months | |
| Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200433 | China |
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| Cisplatin Injection/Carboplatin Injection |
| Drug |
Cisplatin Injection/Carboplatin Injection |
|
| External Beam Radiotherapy (EBRT)/Brachytherapy | Radiation | External Beam Radiotherapy (EBRT)/Brachytherapy |
|
| Paclitaxel Injection | Drug | Paclitaxel Injection. |
|
| Up to approximately 30 months |
| Objective Response Rate(ORR) | judged based on RECIST 1.1 criteria according to Investigator's assessment | Up to approximately 60 months |
| Duration of response (DoR) | judged based on RECIST 1.1 criteria according to Investigator's assessment | Up to approximately 60 months |
| Progression free survival (PFS) | judged based on RECIST 1.1 criteria according to Investigator's assessment | Up to approximately 60 months |
| Overall Survival (OS) | judged based on RECIST 1.1 criteria according to Investigator's assessment | Up to approximately 60 months |
| 2-year Progression free survival | judged based on RECIST 1.1 criteria according to Investigator's assessment | Up to approximately 24 months |
| 3-year Overall Survival | judged based on RECIST 1.1 criteria according to Investigator's assessment | Up to approximately 36 months |
| 12-week Complete Response | judged based on RECIST 1.1 criteria according to Investigator's assessment | Up to approximately 4 months |
| PK traits of SHR-1316: Cmax | Up to approximately 24 months |
| PK traits of SHR-1316: Tmax | Up to approximately 24 months |
| PK traits of SHR-1316: AUC0-t | Up to approximately 24 months |
| PK traits of SHR-1316: AUC0-∞ | Up to approximately 24 months |
| PK traits of SHR-1316: t1/2 | Up to approximately 24 months |
| PK traits of SHR-1316: CL | Up to approximately 24 months |
| PK traits of SHR-1316: Vss | Up to approximately 24 months |
| Serum concentration of SHR-1316 at each planned blood collection time point | Up to approximately 24 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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