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ADRIATIC study explored the benefits of immune maintenance therapy after LS-SCLC radiotherapy and chemotherapy. In the presence of immunotherapy, is it necessary to increase the dosage of radiotherapy and can it further improve the efficacy? This study aims to explore the efficacy and safety of simultaneous integrated boost hyperfractionation radiotherapy combined with probiotics and Adalberg monoclonal antibody consolidation therapy for small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance | Experimental | Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year. |
|
| Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance | Placebo Comparator | Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Drug | Subjects received probiotics before radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| one year progression free survival rate | one year | |
| Complete response rate at the end of radiotherapy for one month | at the end of radiotherapy for one month |
| Measure | Description | Time Frame |
|---|---|---|
| One year overall survival rate | one year | |
| one year Survival rate without distant metastasis | one year | |
| Adverse reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingwen Fan | Contact | +86 13651669687 | wenxingfan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | China |
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| concurrent Hyperfractionated Radiotherapy | Radiation | Increase radiation dose on the basis of conventional radiotherapy |
|
| Immunotherapy | Drug | Adebrelimab, 1200mg,q3w,2 year |
|
| one year |
| ID | Term |
|---|---|
| D019936 | Probiotics |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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