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This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab Combined With Chemotherapy | Drug | Patients with newly diagnosed ES-SCLC receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation is conducted. Those who experience remission are sequentially treated with tislelizumab combined with consolidation chest radiotherapy (TRT). After the consolidation therapy is completed, tislelizumab maintenance therapy is received until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The maximum duration of treatment is 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | Progression free survival (PFS): defined as the period from enrollment to the date of the first recorded tumor progression (assessed according to RECIST v1.1 criteria, regardless of whether treatment is continued or not) or the date of death from any cause, whichever occurs first, assessed up to 24 months. | From enrollment to the date of the first recorded tumor progression (assessed according to RECIST v1.1 criteria, regardless of whether treatment is continued or not) or the date of death from any cause, whichever occurs first, assessed up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Defined as the proportion of patients with BOR rated as CR or PR according to RECIST v1.1 criteria from the start of enrollment. If the therapeutic effect reaches CR or PR, the patient must confirm it no less than 4 weeks (28 days) after the initial evaluation, assessed up to 6 weeks (42 days) . The best overall efficacy refers to the best efficacy evaluated by the researcher, which is the best efficacy recorded during the period from the patient's enrollment to the date of objective recording of disease progression according to RECIST v1.1 standards or the date of starting subsequent anti-tumor treatment (whichever occurs first). For patients who have not recorded disease progression or started subsequent anti-tumor treatment, the optimal overall efficacy will be determined based on all efficacy evaluation results. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of treatment-emergent adverse events | Defined as the incidence of treatment-emergent adverse events [safety and tolerability]. | Adverse event occurrence from enrollment to completion of patient treatment, assessed up to 24 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhou, Professor | Contact | 86-13883465672 | 1052308491@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Affiliated Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39252865 | Result | Chen D, Zou B, Li B, Gao A, Huang W, Shao Q, Meng X, Zhang P, Tang X, Hu X, Zhang Y, Guo J, Zhao C, Yuan J, Li Q, Zhu C, Yu J, Wang L. Adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC): a phase II trial. EClinicalMedicine. 2024 Aug 21;75:102795. doi: 10.1016/j.eclinm.2024.102795. eCollection 2024 Sep. |
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| The proportion of patients with BOR rated as CR or PR according to RECIST v1.1 criteria from the start of enrollment to progressive disease, assessed up to 24 months. |
| Disease control rate | Defined as the proportion of patients who, from enrollment, have the best overall response (BOR) evaluated according to RECIST v1.1 criteria as complete response (CR), partial response (PR), and disease stability (SD). | The proportion of patients who, from enrollment to progressive disease, assessed up to 24 months |
| Duration of remission | Defined as the time from the first recorded objective remission to recurrence or death for any reason, as determined by the researcher based on RECIST v1.1, whichever occurs first. | From enrollment to the first recorded objective remission to recurrence or death for any reason, as determined by the researcher based on RECIST v1.1, whichever occurs first, assessed up to 24 months. |
| Overall survival | Defined as the time between enrollment and death from any cause. | The time between enrollment and death from any cause, assessed up to 24 months. |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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