A Study of DC-CIK to Treat Hepatocellular Carcinoma

Phase 2

• Conditions: Hepatocellular Carcinoma (HCC)
• Interventions: Biological: Dendritic and Cytokine-induced Killer Cells

• Registration Number: NCT01821482
• Lead Sponsor: Guangxi Medical University

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.

Study Timeline

• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-03-29
• Status Verified: 2013-04
• Study First Posted: 2013-04-01
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-12
• Study Start: 2013-05
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
progression-free survival(PFS)	1 month

Secondary Outcome Measures

Name	Time	Method
Overall survival(OS)	1 month
quality of life (QOL)	month

Trial Locations

Locations (1)

The first Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China