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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
N/A
Open (Enrolling)
Both
Carcinoma, Hepatocellular

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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:



- Male or female patients over 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 less than 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 performance status of 0, or 1.

- Cirrhotic status of Child-Pugh class A only.

- The following laboratory parameters:

- 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 ( over grade 2 National Cancer Institute-Common
Terminology Criteria for Adverse Events 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:

Interventional

Study Design:

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

Outcome Measure:

Time to recurrence

Outcome Description:

To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.

Outcome Time Frame:

5-year

Safety Issue:

No

Authority:

Sun Yat-sen University: China

Study ID:

NCT00769106

NCT ID:

NCT01749865

Start Date:

October 2008

Completion Date:

October 2015

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular

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