NCT00819650

Brief Summary

The aim of this study is to analyze the therapeutic effect of adjuvant Licartin therapy after resection.Patients receiving curative resection (R0) were randomized to postoperative Licartin group and no Licartin group. The time to recurrence ,the overall survival as well as the incidence of complications after therapy was observed to confirm the role of adjuvant therapy of Licartin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

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, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 1, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

January 1, 2009

Last Update Submit

March 30, 2016

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomaadjuvant therapyLicartintime to recurrenceoverall survival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    2010

Secondary Outcomes (1)

  • Time to recurrence

    2010

Study Arms (2)

Licartin

EXPERIMENTAL

patients who receive Licartin therapy after liver resection

Drug: Licartin (generic name,[131I]metuximab injection)

placebo

NO INTERVENTION

control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group with patients who receive Licartin therapy after liver resection

Interventions

Licartin (generic name,[131I]metuximab injection)DRUG

Licartin, radioiodination of Metuximab with Na\[131I\],with radiochemical purity above 95% and specific activity between 173.25-288.75 MBq/ml.All patients in the treatment group received Licartin 3 times at an interval of 28 days beginning from the 4th week after liver resection

Also known as: no adjuvant therapy after liver resection
Licartin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with HCC who received curative liver resection (R0)and with positive expression of HAb18G/CD147 in the HCC tissues
  • Karnofsky Performance Score performance over 60
  • The functions of the kidney, heart and lung and the blood system are normal and fittable for Licardin therapy.
  • The liver function is of grade A or B in Child-Pugh classification.
  • Patients give consent to the test.

You may not qualify if:

  • Negative expression of HAb18G/CD147 in the HCC tissues
  • Allergic history to biologic products(Licartin)
  • Any of the situation list below: WBC less than 2000/ml, Hb less than 90g/L or PLT less than 50000/ml, bilirubin level more than 2.5 times the upper limit of normal value, serum albumin less than 32 g/l.
  • Severed disease of the heart, lung, kidney, brain and blood system.
  • Other severed disease might affect the trial .
  • Patients would not sign the consent to the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

Related Publications (1)

  • Li J, Xing J, Yang Y, Liu J, Wang W, Xia Y, Yan Z, Wang K, Wu D, Wu L, Wan X, Yang T, Gao C, Si A, Wang H, Wu M, Lau WY, Chen Z, Shen F. Adjuvant 131I-metuximab for hepatocellular carcinoma after liver resection: a randomised, controlled, multicentre, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):548-560. doi: 10.1016/S2468-1253(19)30422-4. Epub 2020 Mar 9.

    PMID: 32164877DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

metuximab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Feng Shen, MD

    Eastern hepatobilliary surgery hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

First Submitted

January 1, 2009

First Posted

January 9, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

April 1, 2016

Record last verified: 2016-03

Locations

CN(1)