Clinical Trial

Disease: Advanced Hepatocellular Carcinoma, HCC, (NCT04417764)

Disease info:

Liver cancer begins in the cells of the liver. The most common form of liver cancer begins in cells called hepatocytes and is called hepatocellular carcinoma (HCC).

The risk of hepatocellular carcinoma, is higher in people with long-term liver diseases. It's also higher if the liver is scarred by infection with hepatitis B or hepatitis C. Hepatocellular carcinoma is more common in people who drink large amounts of alcohol and who have an accumulation of fat in the liver.

 

Frequency:
HCC accounts for 65% of all cases of liver cancers. The American Cancer Society estimates approximately 41,210 new cases of primary liver cancer and intrahepatic bile duct cancer will be diagnosed in the United States in 2023.
Official title:
Safety and Effect Assessment of TACE in Combination With Autologous PD-1 Knockout Engineered T Cells by Percutaneous Infusion in the Paitents With Advanced Hepatocellular Carcinoma.
Who:

Contact

Name: Wei Wang, MD

Phone: 86-0731-88618411

Email: cjr.wangwei@vip.163.com

 

Name: Xiaoqian Ma, MD   

Phone: 86-0731-88618413    

Email: 85316745@qq.com   

Partners:
Locations:

China, Hunan

The 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China, 410013

Study start:
Jun. 20, 2019
Enrollment:
10 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
Programmed cell death protein 1 (PDCD1)
Delivery method:
Electroporation - Ex-vivo
Note:
knockout-T cells from autologous origin
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a clinical study to investigate the safety and effect of transcatheter arterial chemoembolization (TACE) in combination with PD-1 knockout engineered T cells in the Patients with advanced hepatocellular carcinoma. TACE would block the blood supply of the tumor to achieve ischemic, hypoxic and necrotic effects. The PD-1 knockout engineered T cells were also prepared from autologous origin using CRISPR Cas9 technology. The patients performed one TACE treatment followed by 3 cycles of PD-1 edited T cells by percutaneous infusion in the peripheral of tumor under the guide of CT every four weeks. The safety and clinical efficacy will be evaluated. Biomarkers and immunological markers will be monitored.

Last updated: Dec. 28, 2023
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