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This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of tislelizumab combined with nintedanib as consolidation therapy for patients with limited-stage small cell lung cancer after concurrent chemoradiotherapy, and to explore the prognostic markers related to the therapeutic effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Patients with limited-stage small cell lung cancer who did not progress after induction chemoradiotherapy were treated with tislelizumab (200mg Q3W, D1) combined with nintedanib (150mg,bid) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab and nintedanib | Drug | Tislelizumab (200mgQ3W, D1) combined with nintedanib (150mg bid) until disease progression, death, or the occurrence of intolerable toxic reactions |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival(PFS) | The time from the randomization to the first occurrence of imaging disease progression or death | Half a year after all patients were enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | The time from the first administration of the drug to death due to any cause | Two years after the end of group enrollment |
| One-year progression-free survival rate | one year after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jing wang | Contact | 0532-82913035 | wangstella5@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Qingdao University | Qingdao | Shandong | China |
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| The incidence rate of radiation pneumonitis | one year after the end of group enrollment |
| Disease Control Rate | The proportion of patients whose tumors achieved remission (PR + CR) and stable lesions (SD). | Half a year after the study was enrolled |
| Objective response rate | Half a year after the study was enrolled |
| Qingdao Central Hospital Affiliated to Rehabilitation University | Qingdao | Shandong | China |
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| Qingdao Municipal Hospital | Qingdao | Shandong | China |
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| Weihai Municipal Hospital | Weihai | Shandong | China |
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| Yantai Yuhuangding Hospital | Yantai | Shandong | China |
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| Zibo Fourth People's Hospital | Zibo | Shandong | 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 |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| C530716 | nintedanib |
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