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A phase 2, multicenter, randomized, open-label study of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus the best salvage therapy (BST) in patients with highly advanced hepatocellular carcinoma

A phase 2, multicenter, randomized, open-label study of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus the best salvage therapy (BST) in patients with highly advanced hepatocellular carcinoma

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220441
Enrollment
Unknown
Registered
2007-09-18
Start date
2007-09-18
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

Advanced hepatocellular carcinoma

Interventions

investigational material(s) Generic name etc : Interferon alpha-nl INN of investigational material : Therapeutic category code : 639 Other biological preparations Dosage and Administration for Invest

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion, patients with no remote metastasis (extrahepatic metastasis), patients who have not received intra-arterial hepatic chemoembolization or systemic chemotherapy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy/safety—

Outcome results

None listed

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