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This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICI+EC/EP+TRT | Experimental | Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | From the date of enrollment to the date of disease progression | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR as assessed by the Investigator according to RECIST v1.1 | Up to 2 years |
| Disease Control Rate (DCR) | DCR as assessed by the Investigator according to RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Jin, Dr. | Contact | +86 351 3365422 | jingang2018@sina.com | |
| Chen Zhang | Contact | +86 351 3365422 | jingang2018@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Gang Jin, Dr. | Second Hospital of Shanxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jincheng General Hospital | Recruiting | Jincheng | Shanxi | 048000 | 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 |
|---|---|
| C000707970 | tislelizumab |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Etoposide | Drug | Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles). |
|
| Carboplatin or Cisplatin | Drug | Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles). |
|
| Thoracic radiotherapy | Radiation | IMRT 30-45Gy/10-15f |
|
| Up to 2 years |
| Overall Survival (OS) | From the date of enrollment until death by any cause or last follow-up | Up to 2 years |
| Adverse events | Treatment-related adverse events according to CTCAE 5.0. | Up to 2 years |
| Jinzhong third people's hospital | Recruiting | Jinzhong | Shanxi | 032000 | China |
|
| Second Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030000 | China |
|
| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
|
| Shanxi Hospital of Traditional Chinese Medicine | Recruiting | Taiyuan | Shanxi | 030000 | China |
|
| TISCO General Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |