A randomized controlled trial by a parallel group design in a single institution to evaluate the effectiveness of oral adjuvant chemotherapy using uracil-tegafur to prevent recurrence after curative resection of hepatocellular carcinoma

A randomized controlled trial by a parallel group design in a single institution to evaluate the effectiveness of oral adjuvant chemotherapy using uracil-tegafur to prevent recurrence after curative resection of hepatocellular carcinoma - A randomized controlled trial for adjuvant UFT therapy after resection of hepatocelluar carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000445

Enrollment

160

Registered

2006-07-05

Start date

1997-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cases with hepatocellular carcinoma, which is removed curatively and surgically

Interventions

Oral administration of uracil-tegafur (300mg/day) for 1 year after curative resection of hepatocellular carcinoma Only follow-up without any anti-cancer and anti-virus therapy after curative resection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing first curative resection for hepatocellular carcinoma, who met the following entry criteria: cirrhosis of Child-Pugh class A or B; adequate bone marrow and renal functions (white blood cell count >4,000/mm3, platelet count >50,000m3m, and serum creatinine level <1.5 mg/dL)

Exclusion criteria

Exclusion criteria: The presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein, other previous or synchronous malignant disorders, and postoperative dysfunction of any organ

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Japan

Contacts

Public ContactMasatoshi Makuuchi

Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division

makuuchi-tky@umin.ac.jp03-5800-8841

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026