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Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

Primary Purpose

Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Adverse Reaction to Drug

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
thalidomine
tegafur-uracil
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adult Hepatocellular Carcinoma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. stage I-III（TNM: T1-T3） hepatocellular carcinoma
  2. previously received curative surgery
  3. 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

Exclusion Criteria:

  1. other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study
  2. previously received chemotherapy
  3. less than 2 weeks since previous radiotherapy/surgery
  4. 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
  5. serum bilirubin greater than 1.5 times the upper limit of normal range (ULN)
  6. alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than 5 times the ULN
  7. alkaline phosphatase greater than 5 times the ULN
  8. presence of serious concomitant illness which might be aggravated by study medication:uncontrolled infection (active serious infections that are not controlled by antibiotics)
  9. hypersensitivity to thalidomide or compounds pregnant or breast feeding women, or women of child-bearing potential unless using two reliable and appropriate contraceptive method

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thalidomine

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
December 16, 2014
Last Updated
February 5, 2017
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02447679
Brief Title
Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence
Official Title
Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrent After Hepatectomy in High Risk Patients -A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
February 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
After liver resection to remove the hepatocellular carcinioma completely, the patients with high risk of tumor recurrence will be enrolled into this study. The high risk of tumor recurrence depends on tumor characteristics. The risk factors of tumor characteristics included tumor size >5 cm in diameter, abscence of encapsulation, vascular invasion and presence of daughter nodules. The patients with high risk of tumor recurrence will have 1 to 3 risk factors. When the patients are enrolled into the study, oral thalidomide in combination with tegafur-uracil will be applied to prevent tumor recurrence. The patients will be fillowed uo erevy 3 mnoths.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Adverse Reaction to Drug, Vascular Endothelial Growth Factor Overexpression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thalidomine
Arm Type
Experimental
Arm Description
Thalidomide 400mg/day for 1 year tegafur-uracil 2 tables for 1 year.
Intervention Type
Drug
Intervention Name(s)
thalidomine
Other Intervention Name(s)
thado
Intervention Description
thalidomine (400mg/day) for 1 year to prevent HCC recurrence
Intervention Type
Drug
Intervention Name(s)
tegafur-uracil
Other Intervention Name(s)
ufur
Intervention Description
tegafur-uracil (2 tablelet twice a day) for 1 year to prevent HCC recurrence
Primary Outcome Measure Information:
Title
tumor recurrence
Description
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)
Time Frame
every 3 months, up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Chen Lee
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

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