Clinical trial · Interventional
Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence
Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrent After Hepatectomy in High Risk Patients -A Phase II Study
NCT02447679CI-TRIAL-00025827completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Adverse Reaction to Drug | — | UNRESOLVED | — |
| Recurrent Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Vascular Endothelial Growth Factor Overexpression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tegafur-uracil | Drug | Tegafur | ALIAS |
| thalidomine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- thalidomine
- description
- 1. Thalidomide 400mg/day for 1 year 2. tegafur-uracil 2 tables for 1 year.
- interventionNames
- Drug: thalidomine
- Drug: tegafur-uracil
Primary outcomes (1)
- measure
- tumor recurrence
- timeFrame
- every 3 months, up to 5 years
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.