This study is an open, single-arm, single-center phase II clinical study, which aims to evaluate the efficacy and safety of adebelizumab combined with irinotecan liposome in the second-line treatment of advanced small cell lung cancer, explore biomarkers to predict the efficacy, and further select the dominant population in immunotherapy. In this study, 46 patients with extensive SCLC who had previously received immunotherapy combined with chemotherapy were enrolled. Subjects who met the enrollment conditions will be given adebelizumab combined with irinotecan liposome at the same time. After 4-6 cycles of treatment, if their condition has not progressed, they will be treated with adebelizumab until the disease progresses, toxicity can not be tolerated or other reasons specified in the scheme can be terminated. Subjects who finish the treatment will enter the follow-up period for safety follow-up and survival follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Adebellizumab: intravenous drip, 1200mg, the infusion time is controlled between 30-60 minutes, and the infusion is completed within 2 hours at most. It is administered on the first day of each cycle and repeated once every 3 weeks.Irinotecan liposome: intravenous drip, 80mg/m2, infusion time of 30 minutes, the first dose of each cycle, repeated once every 3 weeks.After 4-6 cycles of adebelizumab combined with irinotecan liposome treatment, the subjects who did not develop the disease continued to use adebelizumab (1200mg, D1, Q3W) for maintenance treatment until the disease progressed, the toxicity was intolerable, the subjects voluntarily asked to withdraw and the researchers judged that the subjects needed to withdraw from the study.
Peking university cancer hospital
Beijing, Haidian, China
Progression Free Survival (PFS)
It refers to the time from the date when the subjects enter the group to the time when the disease progresses or dies, whichever comes first.
Time frame: 0-12months
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
the proportion of subjects who achieve CR or PR as the best tumor remission during treatment.
Time frame: through study completion, an average of 1 year
Overall Survival (OS)
The time from the date of admission to the death caused by any cause.
Time frame: 0-5years
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 2 year
Biomarker
ScRNA-seq was used to detect the puncture tissue samples before treatment, so as to analyze the influence of single cell level immune signal pathway and immune microenvironment on the efficacy of immunotherapy and explore biomarkers to predict the efficacy. At the same time, the peripheral blood samples were tested by metabonomics before treatment, after 2 cycles of evaluation and when the disease progressed, so as to explore metabolic markers that can predict and dynamically reflect the efficacy of immunotherapy through non-invasive liquid biopsy.
Time frame: "Baseline" and "after 2 cycles of treatment"
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