A Study of DC-CIK to Treat Hepatocellular Carcinoma

NCT ID: NCT01821482

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-05-31

Brief Summary

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

Detailed 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.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

After complete resection or TACE, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) (every 4 weeks)

Group Type: EXPERIMENTAL

Dendritic and Cytokine-induced Killer Cells

Intervention Type: BIOLOGICAL

B

After complete resection or TACE, Patient only regularly follow up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dendritic and Cytokine-induced Killer Cells

Intervention Type: BIOLOGICAL

Other Intervention Names

DC-CIK

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Weiliang Sun

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanfeng Liu

Role: STUDY_CHAIR

Guangxi Medical University

Locations

The first Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Countries

China

Central Contacts

Hanfeng Liu

Role: CONTACT

86-771-3277289

Facility Contacts

Hanfeng Liu

Role: primary

86-771-3277289

Other Identifiers

HCC-01

Identifier Type: -

Identifier Source: org_study_id