Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

• Status: Completed
• Trial end date: 2017-02-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Tegafur; Thalidomide

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