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A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.

Phase 3
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.

Inclusion Criteria

Inclusion Criteria

- Male or female patients > 18 years of age.

- Without any prior anti-cancer therapy.

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

- Patients already had radical resection of HCC.

- Definition of radical resection in this study:

- All tumors were moved out, with a clean resection margin.

- Number of tumors <= 3.

- Without tumor invasion of the main trunk and first branch of the portal vein, or
hepatic duct, or hepatic vein.

- No hepatic hilum lymphnode metastasis.

- No distance metastasis.

- Hepatocellular carcinoma with histological diagnose.

- No major post-operative complication.

- Patients who have an ECOG PS of 0, or 1.

- Cirrhotic status of Child-Pugh class A only.

- The following laboratory parameters:

- Platelet count >= 70 x 109/L

- Hemoglobin >= 8.5 g/dL

- Albumin >= 3.5 g/dL

- Total bilirubin <= 25umol/L

- Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal

- Serum creatinine <= 1.5 x the upper limit of normal

- Prothrombin time (PT) <= 3 seconds above control.

- Patients who give written informed consent.

Exclusion Criteria

- Previous or concurrent cancer that is distinct in primary site or histology from HCC.

- History of cardiac disease.

- Active clinically serious infections (> grade 2 National Cancer Institute
[NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)

- Known history of human immunodeficiency virus (HIV) infection

- Known Central Nervous System tumors including metastatic brain disease.

- Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry.

- History of organ allograft.

- Known or suspected allergy to the investigational agent or any agent given in
association with this trial.

- Pregnant or breast-feeding patients.

- Any condition that is unstable or which could jeopardize the safety of the patient
and his/her compliance in the study.

Excluded therapies and medications, previous and concomitant:

- Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy.

- Antiviral treatment is allowed.

Type of Study:


Study Design:

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

Outcome Measure:

Time to recurrence (TTR)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Jin-qing Li, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University


China: Ministry of Health

Study ID:

SunYat-senU 5010



Start Date:

June 2008

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • recurrent
  • cytokine-induced killer cell
  • Carcinoma
  • Carcinoma, Hepatocellular