NCT03592706

Brief Summary

The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in：

  1. 1.Reduction of tumor size
  2. 2.Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.

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 Dec 2009

Longer than P75 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

December 1, 2009

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

11.2 years

First QC Date

July 5, 2018

Last Update Submit

April 14, 2020

Conditions

HepatoCellular CarcinomaLiver Cancer

Keywords

HepatoCellular CarcinomaLiver CancerImmune Killer CellsIKCImmune TherapyImmunotherapyCell TherapyIVYIVY02

Outcome Measures

Primary Outcomes (2)

  • Change of tumor size

    Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes

    One year

  • Progression-Free Survival (PFS)

    The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse

    One year

Secondary Outcomes (1)

  • Improvement of immune responses

    One year

Study Arms (2)

IKC and TACE

EXPERIMENTAL

IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization)

Biological: IKC (Immune Killer Cells)Procedure: TACE (Transcatheter Arterial Chemoembolization)

TACE

ACTIVE COMPARATOR

TACE (Transcatheter Arterial Chemoembolization)

Procedure: TACE (Transcatheter Arterial Chemoembolization)

Interventions

IKC (Immune Killer Cells)BIOLOGICAL
Also known as: Autologous Immune Killer Cells
IKC and TACE
TACE (Transcatheter Arterial Chemoembolization)PROCEDURE
Also known as: TACE
IKC and TACETACE

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sign and give written informed consent.
  • Age≧20 years, but\<80 years.
  • Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations.
  • Barcelona staging system stage B and C.
  • Never receive TACE treatment and comply with the standard of TACE treatment.
  • Child-Pugh stage A and B.
  • ECOG performance status 0 to 2.

You may not qualify if:

  • Participant of other clinical trial within the past 4 weeks of screening period.
  • Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
  • Carriers of HIV or HTLV within the past 4 weeks of screening period.
  • With Active acute or chronic infection by (investigator's judgement).
  • Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients (by investigator's judgement) for example:
  • Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.
  • With previous history of encephalopathy within the past six months.
  • Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis).
  • Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri Service General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Chung-Bao Hsieh, MD

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Executive Assistant

CONTACT

(02)8981-3333thesteve@ivy-cd56.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

July 5, 2018

First Posted

July 19, 2018

Study Start

December 1, 2009

Primary Completion

February 1, 2021

Study Completion

August 1, 2021

Last Updated

April 16, 2020

Record last verified: 2020-04

Locations

TW(1)