Progression Free Survival(PFS) Clinical Trial
Official title:
Safety and Efficacy Analysis of Oral Etoposide Combined With Antirotinib and Envollizumab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer
This study aims to explore the safety and efficacy of etoposide capsules combined with anrotinib and Envollizumab in elderly patients with extensive small cell lung cancer.This is a single-center, single-arm exploratory clinical study. 30 patients with extensive small-cell lung cancer are scheduled to be enrolled. Treatment regimen is etoposide capsule 100mg PO qd*7d, antirotinib 12mg PO qd*14d, Emvolizumab 300mg/ IH Q3W, every 21 days, until disease progression or intolerable adverse reactions or death.
The primary objective of this study was to explore the safety and median PFS of etoposide capsules combined with anrotinib and Envollizumab as first-line treatment in elderly patients with extensive small-cell lung cancer (as assessed by the investigators according to RECIST 1.1 criteria).The secondary objective of this study was to evaluate the OS, ORR, and QOL of etoposide capsules combined with Emvolizumab and anrotinib as first-line treatment in elderly patients with extensive small-cell lung cancer.Exploratory aims are to explore predictive or prognostic biomarkers (tissue and/or plasma) associated with therapeutic response or resistance to disease; Analysis of potential biomarkers in biopsy tissue samples and blood samples after disease progression to explore possible mechanisms of therapeutic resistance. To provide a better treatment plan for elderly patients with extensive small cell lung cancer. ;