CIK Treatment for HCC Patient Underwent Radical Resection
This study is currently recruiting participants.
Verified December 2012 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
LI Sheng-ping, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01749865
First received: December 12, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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Purpose
This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Biological: Cytokine-Induced Killer Cells |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection |
Further study details as provided by Sun Yat-sen University:
Primary Outcome Measures:
- Time to recurrence [ Time Frame: 5-year ] [ Designated as safety issue: No ]To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.
Secondary Outcome Measures:
- Disease Free Survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]Disease Free Survival
Other Outcome Measures:
- Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]To evaluate safety of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A, CIK
Biological/Vaccine: Cytokine-Induced Killer Cells
|
Biological: Cytokine-Induced Killer Cells
Cytokine-Induced Killer Cells treatment for 4 cycles
Other Name: CIK
|
|
No Intervention: B, CONTROL
Regular follow up with no intervention
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749865
Locations
| China, Guangdong | |
| Immunotherapy | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: LI XU, M.D. 862087343582 daughsea@hotmail.com | |
| Sub-Investigator: LI XU, M.D. | |
Sponsors and Collaborators
Sun Yat-sen University
More Information
No publications provided
| Responsible Party: | LI Sheng-ping, Vice director, Sun Yat-sen University Cancer Center, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01749865 History of Changes |
| Other Study ID Numbers: | NCT00769106 |
| Study First Received: | December 12, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | Sun Yat-sen University: China |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 16, 2013