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This single-arm, Phase II study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 [PD-1] antibody) combination with Apatinib in participants with ES-SCLC who was response or stable disease after firstline standard chemotherapy. Participants will be receive camrelizumab +apatinib on 21-day cycles until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab Plus Apatinib | Experimental | camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab Plus Apatinib | Drug | -Drug: camrelizumab Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle,until PD. Other Name: SHR-1210 -Drug: Apatinib Mesylate Apatinib capsules 250 mg given orally , once daily in 21-day cycle ,until PD. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) | From the date of maintenance randomization to the date of first document of progression or symptomatic deterioration, or death due to any cause | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | From the date of maintenance randomization until death from any cause, with participants last known to be alive censored at the date of last contact | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0 | up to 24 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiming Wang, Doctor | Contact | 0086-13783590691 | qimingwang1006@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiming Wang, Doctor | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |