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This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy
This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | chemo-immunotherapy followed by thoracic radiotherapy and PD-1/PD-L1 maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thoracic radiotherapy | Radiation | Four courses of carboplatin/etoposide/anti-PD-1/PD-L1 every 3 weeks All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, thoracic radiotherapy of 45 Gy/15 fractions. PD-1/PD-L1 maintenance therapy concurrently and after thoracic radiotherapy at least more than 6 months, or until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year progression-free survival | PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-1/PD-L1 inhibitor to disease progression. | 12 months after last patient entry |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year overall survival | 12 months after last patient entry | |
| toxicities | Number of participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai jiaotong univestigy school of medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | 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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|
| 12 months after last patient entry |
| 5-year overall survival | 5-year after last patient entry |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |