NCT02487017

Brief Summary

Evaluation of DC-CIK cells combined TACE treatment for HCC

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started May 2015

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 24, 2016

Status Verified

December 1, 2015

Enrollment Period

3.6 years

First QC Date

June 29, 2015

Last Update Submit

May 23, 2016

Conditions

Hepatocellular CarcinomaNeoplasmsDigestive System Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 years

Secondary Outcomes (3)

  • Progress-free survival

    3 years

  • Quality of life (QOL)

    3 years

  • Phenotypic analysis of T cells

    1 years

Study Arms (2)

Transcatheter Arterial Chemoembolization

SHAM COMPARATOR

Transcatheter Arterial Chemoembolization treatment according to NCCN guidelines，patients will receive 5-FU Hepatic arterial infusion,3 cycles at least.

Procedure: Transcatheter Arterial Chemoembolization (TACE)

DC-CIK

EXPERIMENTAL

After accepting concurrent TACE according to NCCN guidelines,patients will receive 3 cycles of DC-CIK treatment at least.

Biological: DC-CIK

Interventions

Transcatheter Arterial Chemoembolization (TACE)PROCEDURE

Transcatheter Arterial Chemoembolization (TACE): 5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml,the perfusion time should not be less than 20 min

Transcatheter Arterial Chemoembolization
DC-CIKBIOLOGICAL

Transcatheter Arterial Chemoembolization (TACE): 5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml, the perfusion time should not be less than 20 min DC-CIK: 8×10\^9 DC-CIK cells for each infusion, IV (in the vein) for each infusion at least 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32

DC-CIK

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old;
  • Histologically confirmed with Hepatocellular Carcinoma at stage I-II;
  • Patients who can accept Transcatheter Arterial Chemoembolization ;
  • Patients who have a life expectancy of at least 3 months;
  • Patients who have a Child-Pugh:A/B; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

You may not qualify if:

  • White blood cell \<3 x 10\^9/L,Platelet count \<75 x 10\^9/L;BUN and Cr more than normal limits on 3.0 times ;
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial;
  • Pregnant or lactating patients;
  • Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
  • Patients who are suffering from serious autoimmune disease;
  • Patients who had used long time or are using immunosuppressant;
  • Patients who had active infection;
  • Prior use of any anti-cancer treatment in 30 days;
  • Now or recently will join another experimental clinical study ;
  • History of organ allograft;
  • Other situations that the researchers considered unsuitable for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yantai City Hospital for Infectious Diseases

Yantai, Shandong, 264000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularNeoplasmsDigestive System Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Xiangzhong Liu, Professor

    Yantai City Hospital for Infectious Diseases Immunotherapy center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangzhong Liu, Professor

CONTACT

0535-6606236xiangzhong8686@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 1, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 24, 2016

Record last verified: 2015-12

Locations

CN(1)