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

NCT02568748 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-04-27

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER
  • Sherief Abd-Elsalam

    lead OTHER

Principal Investigators

  • Dina H Ziada, Prof · Hepatology dept.-Tanta

  • Hanan H Soliman, Prof · Hepatology dept.-Tanta

  • Enas Arafa, Prof · Clinical pathology dept.

  • Sherief Abd-Elsalam, lecturer · Hepatology dept.-Tanta

  • Abdelrahman Zekri, Professor · Pathology dept.- Cairo university

  • Amre Elbadry, Professor · Interventional radiology- Tanta university

  • Marwa Salama, Ass.lecturer · Hepatology dept.- Tantauniversity

  • Ahmed Elsharkawy, Ass.lecturer · Interventional radiology- Tanta university

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-06-30
Completion
2019-10-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02568748 on ClinicalTrials.gov