Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma (HCC)

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

progression-free survival(PFS)

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Hanfeng Liu

Investigator Role:

Study Chair

Investigator Affiliation:

Guangxi Medical University

Authority:

China: Ministry of Health

Study ID:

HCC-01

NCT ID:

NCT01821482

Start Date:

May 2013

Completion Date:

May 2018

Related Keywords:

  • Hepatocellular Carcinoma (HCC)
  • Hepatocellular carcinoma, DC-CIK
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location