Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

NCT ID: NCT02447679

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2017-02-02

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.

Conditions

Adult Hepatocellular Carcinoma; Recurrent Hepatocellular Carcinoma; Adverse Reaction to Drug; Vascular Endothelial Growth Factor Overexpression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

thalidomine

1. Thalidomide 400mg/day for 1 year

2. tegafur-uracil 2 tables for 1 year.

Group Type: EXPERIMENTAL

thalidomine

Intervention Type: DRUG

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

tegafur-uracil

Intervention Type: DRUG

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

Interventions

thalidomine

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

Intervention Type: DRUG

tegafur-uracil

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

Intervention Type: DRUG

Other Intervention Names

thado; ufur

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Chen Lee

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

CGMF-IRB-97-1291A

Identifier Type: -

Identifier Source: org_study_id