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Evaluation of Cytokine-induced Killer (CIK) Cells as Therapy or Adjuvant Treatment for Advanced HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568748
Recruitment Status : Unknown
Verified April 2017 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was:  Recruiting
First Posted : October 6, 2015
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Brief Summary:

Hepatocellular carcinoma (HCC) is the fifth most common malignancy in the world and the third most common cause of cancer-related deaths complicating liver cirrhosis in most cases. In Egypt, there has been a remarkable increase of the proportion of HCC among CLD patients from 4.0% to 7.2% over a decade. This rising proportion may be explained by the increasing risk factors such as the emergence of HCV over the same period of time, the contribution of HBV infection, improvement of the screening programs and diagnostic tools of HCC as well as the increased survival rate among patients with cirrhosis to allow time for some of them to develop HCC. The only curative treatment modalities for HCC are surgery, local ablation, and liver transplantation which have high recurrence rate either due to viral hepatitis infection or cirrhosis leading to low success rate and high economic burden.

Unfortunately, the majority of patients have unresectable disease at diagnosis. So, patients search for palliative very expensive therapies including chemotherapy and radiotherapy which often fail to eradicate tumor lesions completely and tend to result in many adverse events.Thus, novel approaches for treatment options are needed for patients with advanced HCC .

In recent years, immunotherapy has emerged as an efficacious treatment modality with encouraging efficacy and slight adverse events in cancer therapy [Stroncek 2010]. Cytokine-induced killer CIK cells therapy has been evaluated as an adoptive cell immunotherapy for cancer patients in a number of clinical trials and the promising efficacy of CIK cells on malignancies has been proved.


Condition or disease Intervention/treatment Phase
Liver Cancer Biological: CIK Procedure: TACE Phase 3

Detailed Description:

Hepatocellular carcinoma (HCC) is the fifth most common malignancy in the world and the third most common cause of cancer-related deaths complicating liver cirrhosis in most cases. In Egypt, there has been a remarkable increase of the proportion of HCC among CLD patients from 4.0% to 7.2% over a decade. This rising proportion may be explained by the increasing risk factors such as the emergence of HCV over the same period of time, the contribution of HBV infection, improvement of the screening programs and diagnostic tools of HCC as well as the increased survival rate among patients with cirrhosis to allow time for some of them to develop HCC. The only curative treatment modalities for HCC are surgery, local ablation, and liver transplantation which have high recurrence rate either due to viral hepatitis infection or cirrhosis leading to low success rate and high economic burden..

Unfortunately, the majority of patients have unresectable disease at diagnosis. So, patients search for palliative very expensive therapies including chemotherapy and radiotherapy which often fail to eradicate tumor lesions completely and tend to result in many adverse events.Thus, novel approaches for treatment options are needed for patients with advanced HCC .

In recent years, immunotherapy has emerged as an efficacious treatment modality with encouraging efficacy and slight adverse events in cancer therapy. Cytokine-induced killer CIK cells therapy has been evaluated as an adoptive cell immunotherapy for cancer patients in a number of clinical trials and the promising efficacy of CIK cells on malignancies has been proved. . Clinical studies have demonstrated that it is an excellent method to prevent tumor recurrence and has preliminarily shown its efficacy in inhibiting recurrence and metastasis of primary HCC -Peripheral blood mononuclear cells (PBMC)from patients with primary HCC were incubated in vitro and induced into CIK cells in the presence of various cytokines such as interferon-gamma (IFN-ã ), interleukin-1 (IL-1), IL-2, and monoclonal antibody (mAb) against CD3. CIK cells infusion will be performed Once every week, with a total of at least4infusions. Infusion will be given intrahepatic or via peripheral veins .

The serial biological events following CIK cells administration to a cancer patient includes (a) immune activation and effective lymphocytes (mostly C D3+CD 5 6+Tlymphocytes) proliferation starting early after the first administration , ( b) clinically measurable antitumor effect mediated by activated immune cells over weeks to months ,and (c) potential delayed effect on patient survival several months or even longer after the first administration.

Our team have many grants in field of HCC biomarkers discovery and managements from NIH as multicenter studies which got many international publication. As well as grant for the use of laboratory techniques in the cultivation of stem cells for specialized cells used in the treatment of different diseases which got publication in this era. we aim in this project to cultivate patients cells in vitro to get CIK cells and study the safety and efficacy of immunization with specific antihepatocellular carcinoma Cytokine -induced killer cells in Egyptian patients with advanced hepatocellular carcinoma as treatment or adjuvant treatment in comparison with traditional treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No Masking
Primary Purpose: Treatment
Official Title: Evaluation of Cytokine-induced Killer (CIK) Cells as Therapy or Adjuvant Treatment for Patients With Advanced Hepatocelluler Carcinoma
Study Start Date : October 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CIK with TACE for HCC stage B
HCC patients stage B treated with TACE and CIK as adjuvant therapy.
Biological: CIK
Cytokine -induced killer cells in Egyptian patients with advanced hepatocellular carcinoma as treatment or adjuvant treatment in comparison with traditional treatment.

Procedure: TACE
Trans-arterial chemoembolization

Experimental: TACE only for HCC stage B
HCC patients stage B treated with TACE without receiving CIK cells infusion
Procedure: TACE
Trans-arterial chemoembolization

Experimental: CIK in HCC stage C or D
HCC stage C or D will receive supportive treatment in addition to CIK cells infusion
Biological: CIK
Cytokine -induced killer cells in Egyptian patients with advanced hepatocellular carcinoma as treatment or adjuvant treatment in comparison with traditional treatment.

No Intervention: Supportive treatment in HCC stage C or D
HCC stage C or D will receive supportive treatment only .



Primary Outcome Measures :
  1. Number of patients with ablated hcc [ Time Frame: 1 year ]
    patients with ablated hcc



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with advanced HCC and not fit for resection or local ablative therapies stage B (according Barcelona Clinic Liver Cancer (BCLC) Staging system ).
  2. Patient with HCC and portal vein thrombosis stage C.
  3. Patients with HCC and lymphatic or distant metastases stage D.

Exclusion Criteria:

  1. Patients with HCC and fit for radical or local ablation (stage 0 and A) therapies.
  2. Platelet count below 50,000 / dl
  3. Prothrombin activity below 50%
  4. All patients will sign a written informed consent after explaining the details and possible hazards of the procedure to them. Those who will refuse to share in the study will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568748


Contacts
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Contact: Sherief Abd-Elsalam, lecturer 00201095159522 Sherif_tropical@yahoo.com
Contact: Sherief Abd-Elsalam, lecturer 00201095159522 Sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Cairo, Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sub-Investigator: Ahmed Elsharkawy, Ass. lect.         
Sponsors and Collaborators
Sherief Abd-Elsalam
Tanta University
Investigators
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Principal Investigator: Dina H Ziada, Prof Hepatology dept.-Tanta
Study Director: Hanan H Soliman, Prof Hepatology dept.-Tanta
Study Director: Enas Arafa, Prof Clinical pathology dept.
Study Director: Sherief Abd-Elsalam, lecturer Hepatology dept.-Tanta
Study Chair: Abdelrahman Zekri, Professor Pathology dept.- Cairo university
Study Chair: Amre Elbadry, Professor Interventional radiology- Tanta university
Study Chair: Marwa Salama, Ass.lecturer Hepatology dept.- Tantauniversity
Study Chair: Ahmed Elsharkawy, Ass.lecturer Interventional radiology- Tanta university
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Responsible Party: Sherief Abd-Elsalam, Study director, Tanta University
ClinicalTrials.gov Identifier: NCT02568748    
Other Study ID Numbers: CIK Tanta university
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases