A Study of DC-CIK to Treat Hepatocellular Carcinoma

Guangxi Medical University

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Biological: Dendritic and Cytokine-induced Killer Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01821482

HCC-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Biological: Dendritic and Cytokine-induced Killer Cells

B

No Intervention group

Description:

After complete resection or TACE, Patient only regularly follow up