NCT02447679

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

Completed Phase 2 Last updated 5 February 2017

What this trial tests

Phase 2 trial testing thalidomine in Adult Hepatocellular Carcinoma in 40 participants. Completed in 2 February 2017.

Timeline

1 August 2010

Primary endpoint
31 January 2017

2 February 2017

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	40
Start date	1 August 2010
Primary completion	31 January 2017
Estimated completion	2 February 2017
Sites	1 location across Taiwan

Drugs / interventions tested

• thalidomine — full drug profile →
• tegafur-uracil — full drug profile →

Conditions studied

• Adult Hepatocellular Carcinoma — all drugs for Adult Hepatocellular Carcinoma →
• Recurrent Hepatocellular Carcinoma — all drugs for Recurrent Hepatocellular Carcinoma →
• Adverse Reaction to Drug — all drugs for Adverse Reaction to Drug →
• Vascular Endothelial Growth Factor Overexpression — all drugs for Vascular Endothelial Growth Factor Overexpression →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 20 to 75, any sex, with Adult Hepatocellular Carcinoma or Recurrent Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 * Biomarker

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk factors and prevention of hepatocellular carcinoma in the era of precision medicine.
   Fujiwara N, Friedman SL, Goossens N, Hoshida Y. · · 2018 · cited 519× · PMID 28989095 · DOI 10.1016/j.jhep.2017.09.016
2. Generic chemoprevention of hepatocellular carcinoma.
   Athuluri-Divakar SK, Hoshida Y. · · 2019 · cited 18× · PMID 30221358 · DOI 10.1111/nyas.13971