Evaluation of Cytokine-induced Killer (CIK) Cells as Therapy or Adjuvant Treatment for Advanced HCC
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 4, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedApril 27, 2017
April 1, 2017
3.7 years
October 4, 2015
April 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with ablated hcc
patients with ablated hcc
1 year
Study Arms (4)
CIK with TACE for HCC stage B
EXPERIMENTALHCC patients stage B treated with TACE and CIK as adjuvant therapy.
TACE only for HCC stage B
EXPERIMENTALHCC patients stage B treated with TACE without receiving CIK cells infusion
CIK in HCC stage C or D
EXPERIMENTALHCC stage C or D will receive supportive treatment in addition to CIK cells infusion
Supportive treatment in HCC stage C or D
NO INTERVENTIONHCC stage C or D will receive supportive treatment only .
Interventions
Cytokine -induced killer cells in Egyptian patients with advanced hepatocellular carcinoma as treatment or adjuvant treatment in comparison with traditional treatment.
Eligibility Criteria
You may qualify if:
- Patients with advanced HCC and not fit for resection or local ablative therapies stage B (according Barcelona Clinic Liver Cancer (BCLC) Staging system ).
- Patient with HCC and portal vein thrombosis stage C.
- Patients with HCC and lymphatic or distant metastases stage D.
You may not qualify if:
- Patients with HCC and fit for radical or local ablation (stage 0 and A) therapies.
- Platelet count below 50,000 / dl
- Prothrombin activity below 50%
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sherief Abd-Elsalamlead
- Tanta Universitycollaborator
Study Sites (1)
Sherief Abd-Elsalam
Cairo, Tanta, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- No Masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Study director
Study Record Dates
First Submitted
October 4, 2015
First Posted
October 6, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2019
Study Completion
October 1, 2019
Last Updated
April 27, 2017
Record last verified: 2017-04