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Phase I/II Study of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma

Phase I/II Study of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma - Phase I/II Study of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005697
Enrollment
42
Registered
2011-06-01
Start date
2011-05-01
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

Hepatocellular Carcinoma

Interventions

Capecitabine, Peginterferon Alfa-2a

Sponsors

Chiba University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 20 years-old (Gender does not matter). 2) Acquisition of written informed consent. 3) Have been diagnosed with hepatocellular carcinoma. 4) Surgical resection or local therapy is unlikely to lead to complete necrosis. 5) Not suitable for treatment with sorafenib. 6) ECOG performance status of 0-2. 7) Child-Pugh A. 8) Expected survival more than 12 weeks 9) Among patients who fulfill the inclusion criteria.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of malignancy. 2) Corresponding to the sever heart disease. 3) Active clinically-serious infections. 4) History of HIV infection. 5) Hemodialysis. 6) Clinical or radiological evidence of CNS metastases. 7) Uncontrollable massive ascites, pleural effusion. 8) Clinically-significant gastrointestinal bleeding within 4 weeks prior to study entry. 9) Severe allergy for fluoropyrimidines. 10) HBV-DNA positive and not being treated with nucleotide analogues. 11) Anticoagulant therapy with warfarin potassium. 12) During treatment with Tegafur gimeracil oteracil potassium, or within 7 days after discontinuation. 13) Use Sho-saiko-to. 14) Use oral phenytoin. 15) Severe thyroid disease.

Design outcomes

Primary

MeasureTime frame
Time to Progression (TTP)

Secondary

MeasureTime frame
Overall Survival (OS) Progression Free Survival (PFS) Response Rate (RR) Safety

Countries

Japan

Contacts

Public ContactSadahisa Ogasawara

Chiba University Hospital Department of Gastroenterology

ogasawaras@graduate.chiba-u.jp

Outcome results

None listed

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