DC-CIK Combined With TACE in the Treatment of Hepatocellular Carcinoma

Shenzhen Hornetcorn Biotechnology

Status and phase: Unknown; Phase 2

Conditions: Neoplasms; Hepatocellular Carcinoma; Digestive System Neoplasms

Treatments: Biological: DC-CIK; Procedure: Transcatheter Arterial Chemoembolization (TACE)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02487017

HYK-Hepatocellular Carcinoma

Details and patient eligibility

About

Evaluation of DC-CIK cells combined TACE treatment for HCC

Full description

60 patients with Hepatocellular Carcinoma, who had received Transcatheter Arterial Chemoembolization (TACE) , will be randomly divided into group A (receive DC-CIK+ TACE treatment) or group B (just receive TACE), and the randomize ratio will be 1:1.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years old;
• Histologically confirmed with Hepatocellular Carcinoma at stage I-II;
• Patients who can accept Transcatheter Arterial Chemoembolization ;
• Patients who have a life expectancy of at least 3 months;
• Patients who have a Child-Pugh:A/B; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Exclusion criteria

• White blood cell <3 x 10^9/L,Platelet count <75 x 10^9/L;BUN and Cr more than normal limits on 3.0 times ;
• Known or suspected allergy to the investigational agent or any agent given in association with this trial;
• Pregnant or lactating patients;
• Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
• Patients who are suffering from serious autoimmune disease;
• Patients who had used long time or are using immunosuppressant;
• Patients who had active infection;
• Prior use of any anti-cancer treatment in 30 days;
• Now or recently will join another experimental clinical study ;
• History of organ allograft;
• Other situations that the researchers considered unsuitable for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Transcatheter Arterial Chemoembolization

Sham Comparator group

Description:

Transcatheter Arterial Chemoembolization treatment according to NCCN guidelines，patients will receive 5-FU Hepatic arterial infusion,3 cycles at least.

Treatment:

Procedure: Transcatheter Arterial Chemoembolization (TACE)

DC-CIK

Experimental group

Description:

After accepting concurrent TACE according to NCCN guidelines,patients will receive 3 cycles of DC-CIK treatment at least.

Treatment:

Biological: DC-CIK