NCT05171439

Surufatinib in Advanced Hepatocellular Carcinoma Based on Single-cell Sequencing of Tumor Samples

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib	Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-09-01
• Completion: 2023-03-01
• First posted: 2021-12-29
• Last updated: 2022-04-14

Locations

1 site across 1 country: China