A Study of DC-CIK to Treat Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01821482
• Other study ID #: HCC-01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 27, 2013
• Last updated: April 11, 2013
• Start date: May 2013
• Est. completion date: May 2018

Study information

• Verified date: April 2013
• Source: Guangxi Medical University
• Contact: Hanfeng Liu
• Phone: 86-771-3277289
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).

Description:

About 60 patients with HCC, who had received complete resection or TACE and got Complete remission (CR) or partial response (PR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients > 18 years of age;

2. Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies;

3. Patients who have a life expectancy of at least 12 weeks;

4. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;

5. The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);

6. The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients who had distant metastases;

2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening;

3. Patients who were pregnant or lactating;

4. ECOG perform status = 2;

5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)

Intervention

Biological:
• Dendritic and Cytokine-induced Killer Cells

Locations

Country	Name	City	State
China	The first Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Laboratory findings		1 month	No
Primary	progression-free survival(PFS)		1 month	No
Secondary	Overall survival(OS)		1 month	No
Secondary	quality of life (QOL)		month	No