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This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210+Paclitaxel-albumin+Carboplatin | Experimental | SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first day of each cycle, with intravenous drip. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| 6-month PFS rate | PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Determined using RECIST v1.1 criteria | Up to approximately 24 months |
| Progression-Free Survival(PFS) | PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caicun Zhou, PhD | Contact | caicunzhoudr@126.com | ||
| Shengxiang Ren, PhD | Contact | harry_ren@126.com |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C000711728 | spartalizumab |
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| Up to approximately 24 months |
| Overall Survival(OS) | Defined as the time from randomization to death from any cause | Up to approximately 24 months |
| Number of Subjects with treatment-related adverse events (AEs) | Incidence, nature, and severity of adverse events graded according to the NCI-CTC AE 5.0 | Up to approximately 24 months |