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To explore the effectiveness and safety of adebrelimab combined with chemotherapy and concurrent SBRT for 3 cycles of neoadjuvant treatment followed by surgery in T1-3N0-1M0 limited-stage SCLC
This study plans to enroll 20 patients with resectable limited-stage small cell lung cancer in stage T1-3N0-1M0 who have not been treated before. They will receive 3 cycles of adebelimumab combined with chemotherapy and concurrent SBRT. Surgery will be performed within 4-6 weeks after treatment. After surgery, adjuvant therapy will be considered based on the results of MDT discussion. All patients with tumor recurrence and metastasis will enter survival follow-up. Pathological complete response rate (pCR) and safety indexes were used as the main observation indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant anti-PDL-1 Immunotherapy combined chemotherapy and SBRT | Experimental | Three cycles of neoadjuvant PDL-1 combined chemotherapy and SBRT followed by surgery for limited-stage small cell lung cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adebrelimab and chemotherapy | Drug | 3 cycles of adebrelimab combined with chemotherapy and concurrent SBRT, and undergo surgery within 4-6 weeks after treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR | Pathological Complete Response | Assessed average of 1 month after surgery |
| Safety and Tolerability | Adverse reactions (according to CTCAE v5 classification) | Assessed average of 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| MPR | Major Pathological response | Assessed average of 1 month after surgery |
| Event-Free Survival(EFS) | Refers to the time from randomization to the first occurrence of any of the following events: disease progression that is inoperable, local or distant recurrence, death due to any cause, etc. |
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Inclusion Criteria:
The functional level of each important organ must meet the following requirements:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jinshi liu | Contact | 057188122233 | liujs@zjcc.org.cn | |
| dijian shen | Contact | 13486199461 | shendj@zjcc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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This study plans to enroll 20 patients with previously untreated T1-3N0-1M0 resectable limited-stage small cell lung cancer. They will receive 3 cycles of adebrelimab combined with chemotherapy and concurrent SBRT, and undergo surgery within 4-6 weeks after treatment. After surgery, adjuvant therapy will be considered based on the results of MDT discussion.
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| From the time of enrollment, until the disease relapses or metastasizes,assessed up to 5 years follow-up. |
| Objective Response Rate(ORR) | The proportion of patients whose tumors shrink to a certain amount and remain shrinking for a certain period of time includes complete remission (CR) and partial remission (PR). | From the time of enrollment, assessed before surgery |
| Overall survival(OS) | The time from the start of treatment to the death of the subject due to various causes was calculated based on the intention-to-treat population (ITT). | From the time of enrollment, assessed up to 5 years follow-up. |
| Exploration of tumor efficacy markers | Correlation between MRD biomarkers in tumor tissue and peripheral blood and patients' clinical outcomes, progression, and efficacy. | From the time of enrollment, assessed up to 5 years follow-up. |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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