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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
Chongqing University Affiliated Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGprogression-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.
Time frame: 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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: The time between enrollment and death from any cause, assessed up to 24 months.
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