Immunotherapy Clinical Trial
Official title:
Pilot Study on PD-1 Inhibitors Consolidation After Standard First-line Chemotherapy and Radiotherapy in Extensive-stage Small Cell Lung Cancer
The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received platinum-based chemotherapy and chest radiotherapy. 2-year survival rate of these patients is only about 10%. Therefore, this study aims to explore a comprehensive treatments with low toxicity to further improve the efficacy for these paitents with PD-1 inhibitor.
The study is a prospective pilot trial. The purpose of this study is to evaluate the safety
and efficacy of PD-1 inhibitor consolidation in extensive-stage small cell lung cancer
paitents who received standard first-line chemotherapy and chest radiotherapy ± SABR for
metastasis disease.
The primary endpoint is the safety and objective response rate of treatment. The secondary
objectives are progression free survival(PFS), overall survial. The exploratory end point
includes the correlation of PD-1 expression on the tumor tissue, and the TMB, Immune
Repertoire sequencing derived from the tumor tissue and the blood sample with the efficacy of
treatent. The plan for collection of tumor tissue and blood at baseline at different stages
during or after treatment was defined in the protocol.
The PICCARE-trial has been designed by National Cancer Center/Cancer Hospital, Chinese
Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is PD-1
inhibitor consolidation was safe and effective in the treatment of extensive-stage SCLC after
sandard first-line chemotherapy and radiotherapy.
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