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Spots Global Cancer Trial Database for Surufatinib in Advanced Hepatocellular Carcinoma Based on Single-cell Sequencing of Tumor Samples

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Trial Identification

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

Interventions

Surufatinib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Nanjing Drum tower hospital, Nanjing, Jiangsu, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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