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NCT Number: NCT02447679

Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

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.

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Key information

Conditions

Adult Hepatocellular Carcinoma Adenocarcinoma Adverse Reaction to Drug Carcinoma Carcinoma, Hepatocellular Chemically-Induced Disorders Digestive System Diseases Digestive System Neoplasms Drug-Related Side Effects and Adverse Reactions Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Recurrent Hepatocellular Carcinoma Vascular Endothelial Growth Factor Overexpression

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thalidomine

Drug

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

Other names: thado

tegafur-uracil

Drug

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

Other names: ufur

Primary outcomes

  1. tumor recurrence

    Time frame: every 3 months, up to 5 years

    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)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrent After Hepatectomy in High Risk Patients -A Phase II Study

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
May 19, 2015
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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