NCT02709070

Brief Summary

There is little evidence showed that adjuvant therapy had been shown to extend the survival of patients with hepatocellular carcinoma (HCC) receiving surgical resection. We investigated whether injections of highly-purified Cytotoxic T lymphocytes prolongs recurrence-free survival of patients after resection for HCC.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P25-P50 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Mar 2016

Typical duration for phase_3 hepatocellular-carcinoma

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

March 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

March 10, 2016

Last Update Submit

March 14, 2016

Conditions

Hepatocellular Carcinoma

Keywords

highly-purified CTL

Outcome Measures

Primary Outcomes (1)

  • recurrence free survival

    from the date of randomization to the first recurrence or to death from any cause

    2-year

Secondary Outcomes (1)

  • overall survival

    5-year

Study Arms (2)

resection

ACTIVE COMPARATOR

Resection was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant and the possibility of a negative resection margin. The investigators performed anatomical resection aiming at a resection margin of at least 1 cm. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 minutes and 5 minutes, respectively. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.

Procedure: resection

highly-purified CTL

EXPERIMENTAL

Peripheral blood (20-30mL) for manufacturing the individualized highly-purified CTL agent was collected from the respective participants who were randomized to the immunotherapy group before starting treatment. The highly-purified CTL agent was prepared at a central manufacturing facility. Participants in the immunotherapy group received a number up to 5×10E9 of the highly-purified CTL agent intravenously over 60 minutes without any premedication and then were observed for at least 30 minutes. Participants were scheduled to receive highly-purified CTL: 4-6 treatments at a frequency of once two-week during 6 months after receiving resection, followed by 6-9 treatments during 6 months to 2 years after receiving resection.

Procedure: resectionProcedure: highly-purified CTL

Interventions

resectionPROCEDURE

hepatectomy for HCC

highly-purified CTLresection
highly-purified CTLPROCEDURE

hepatectomy first, followed by highly-purified CTL treatment

highly-purified CTL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age 18-75 years; 2. First diagnosed HCC, no other treatment received; 3.Child-pugh A-B 4. No severe coagulation disorders (prothrombin activity\<40% or a platelet count\<40,000/mm3); 5. Eastern Co-operative Oncology Group performance(ECOG) status 0-1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Lee JH, Lee JH, Lim YS, Yeon JE, Song TJ, Yu SJ, Gwak GY, Kim KM, Kim YJ, Lee JW, Yoon JH. Adjuvant immunotherapy with autologous cytokine-induced killer cells for hepatocellular carcinoma. Gastroenterology. 2015 Jun;148(7):1383-91.e6. doi: 10.1053/j.gastro.2015.02.055. Epub 2015 Mar 4.

    PMID: 25747273BACKGROUND

  • Peng ZW, Zhang YJ, Chen MS, Xu L, Liang HH, Lin XJ, Guo RP, Zhang YQ, Lau WY. Radiofrequency ablation with or without transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma: a prospective randomized trial. J Clin Oncol. 2013 Feb 1;31(4):426-32. doi: 10.1200/JCO.2012.42.9936. Epub 2012 Dec 26.

    PMID: 23269991BACKGROUND

  • Takayama T, Sekine T, Makuuchi M, Yamasaki S, Kosuge T, Yamamoto J, Shimada K, Sakamoto M, Hirohashi S, Ohashi Y, Kakizoe T. Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial. Lancet. 2000 Sep 2;356(9232):802-7. doi: 10.1016/S0140-6736(00)02654-4.

    PMID: 11022927BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.PhD.

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2022

Last Updated

March 16, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share