NCT02447679

Brief Summary

This single-centered phase II clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(VEGF/bFGF) for thalidomide response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_2

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

August 1, 2010

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2017

Completed
Last Updated

February 7, 2017

Status Verified

December 1, 2016

Enrollment Period

6.5 years

First QC Date

December 16, 2014

Last Update Submit

February 5, 2017

Conditions

Adult Hepatocellular CarcinomaRecurrent Hepatocellular CarcinomaAdverse Reaction to DrugVascular Endothelial Growth Factor Overexpression

Outcome Measures

Primary Outcomes (1)

  • tumor recurrence

    Measure a-fetoprotein and perform liver echo to find out tumor recurrence every 3 month. Then, if a tumor/tumors are found in liver echo, tumor recurrence will be confirmed by CT scan. The imaging on CT shows typical HCC pattern. The pilot study is to obtain preliminary information on: * 3-year recurrence-free survival rate * Recurrence-free survival * Safety profile of the treatment * Biomarkers response(VEGF/bFGF)

    every 3 months, up to 5 years

Study Arms (1)

thalidomine

EXPERIMENTAL

1. Thalidomide 400mg/day for 1 year 2. tegafur-uracil 2 tables for 1 year.

Drug: thalidomineDrug: tegafur-uracil

Interventions

thalidomineDRUG

thalidomine (400mg/day) for 1 year to prevent HCC recurrence

Also known as: thado
thalidomine
tegafur-uracilDRUG

tegafur-uracil (2 tablelet twice a day) for 1 year to prevent HCC recurrence

Also known as: ufur
thalidomine

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stage I-III（TNM: T1-T3） hepatocellular carcinoma
  • previously received curative surgery
  • presence at least one and no more than three of the following risk factors ,
  • i.Tumor size ≧ 5 cm ii.presence of microscopic or macrovascular venous invasion iii.presence of satellite nodules/addition nodules iv.no capsular formation v.multiple tumors d.performance status of ECOG 0, 1 e.age between 20 and 75 years f.no residual or recurrent tumors detected by computed tomography (CT) or echo within 3-6 weeks after surgery g.written informed consent to participate in the trial

You may not qualify if:

  • other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study
  • previously received chemotherapy
  • less than 2 weeks since previous radiotherapy/surgery
  • white blood cell (WBC) less than 3,000/mm3 and absolute neutrophil count (ANC) less than 1,500/mm3, and platelets less than 100,000/mm3
  • serum bilirubin greater than 1.5 times the upper limit of normal range (ULN)
  • alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than 5 times the ULN
  • alkaline phosphatase greater than 5 times the ULN
  • presence of serious concomitant illness which might be aggravated by study medication:uncontrolled infection (active serious infections that are not controlled by antibiotics)
  • hypersensitivity to thalidomide or compounds pregnant or breast feeding women, or women of child-bearing potential unless using two reliable and appropriate contraceptive method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularDrug-Related Side Effects and Adverse Reactions

Interventions

Tegafur

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

FluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wei-Chen Lee

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

May 19, 2015

Study Start

August 1, 2010

Primary Completion

January 31, 2017

Study Completion

February 2, 2017

Last Updated

February 7, 2017

Record last verified: 2016-12

Locations

TW(1)