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Efficacy of intra-hepatic arterial chemotherapy (IHAC) vs. sorafenib on advanced hepatocellular carcinoma; a prospective cohort study (ISHCC-cohort)

Efficacy of intra-hepatic arterial chemotherapy (IHAC) vs. sorafenib on advanced hepatocellular carcinoma; a prospective cohort study (ISHCC-cohort) - Intra-hepatic arterial chemotherapy (IHAC) vs. sorafenib for advanced hepatocellular carcinoma; a prospective cohort study (ISHCC-cohort)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002416
Enrollment
700
Registered
2009-09-01
Start date
2009-10-01
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

Sponsors

Kanazawa University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) hepatocellular carcinoma confirmed by dynamic CT or dynamic MRI, or histologically confirmed hepatocellular carcinoma 2) no indication for transplantation, surgical resection, local ablation or transcatheter arterial embolization. 3) Child-Pugh A 4) >=20 years old 5) ECOG Performance Status 0-2 6) oral intake is possible 7) no extrahepatic lesion, 8) more than one measurable disease 9) Adequate baseline organ function: neutrophil > 1,500/mm3, hemoglobin >=8.5g/dl, platelets > 75,000/mm3, serum bilirubin <2.0mg/dL, aspartate aminotransferase and alanine aminotransferase <=5 times of the institutional upper limit, serum creatinine <2.0mg/dL 10) written informed consent 11) life expectancy >=3 months

Exclusion criteria

Exclusion criteria: 1) histrogically confirmed combined type hepatocellular carcinoma or sarcomatous change 2) previous therapy for hepatocellular carcinoma within 30 days 3) inadequate for administration of sorafenib, 5-FU, cisplatin or interferon 4) active double cancer 5) severe complication 6) refractory ascites of pleural effusion 7) inappropriate for entry onto this study in the judgment of the investigator

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
Progression free survival Response rate Tumor control rate Adverse events

Countries

Japan

Contacts

Public ContactTatsuya Yamashita

Kanazawa University Hospital Department of Gastroenterology

ytatsuya@m-kanazawa.jp076-265-2861

Outcome results

None listed

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