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Brief Title: Surufatinib in Advanced Hepatocellular Carcinoma Based on Single-cell Sequencing of Tumor Samples
Official Title: Single-cell Analysis Reveals Surufatinib Mono-therapeutic Efficacy for Second-line Patients With Advanced Hepatocellular Carcinoma: a Single Arm, Open-label, Single Center, Prospective Study
Study ID: NCT05171439
Brief Summary: This is a single-arm, single-center, open-label phase II study designed to assess the efficacy of surufatinib in participants with advanced hepatocellular carcinoma based on single-cell sequencing of tumor samples.
Detailed Description: This is a single-arm, single-center, open-label phase II study designed to assess the efficacy of surufatinib in participants with advanced hepatocellular carcinoma based on single-cell sequencing of tumor samples. The primary outcome measure of the study is the regulation of immune microenvironment in hepatocellular carcinoma, included the proportion of tumor cells, vascular endothelial cells, and various immune cell clusters (including monocytes, macrophages, mast cells, T cells, B cells, dendritic cells, and neutrophils) in tumor samples before and after treatment with surufatinib, and the expression of related genes. Secondary Efficacy Endpoints include Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Nanjing Drum tower hospital, Nanjing, Jiangsu, China