CompletedPhase 2

Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

Taiwan40 participantsStarted 2010-08

Plain-language 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.

Who can participate

Age range20 Years – 75 Years

SexALL

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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 ,

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)

What they're measuring

tumor recurrence

Timeframe: every 3 months, up to 5 years

Trial details

NCT IDNCT02447679

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-31

View on ClinicalTrials.gov More Adult Hepatocellular Carcinoma trials