A Phase II study of TSU-68 in patient with hepatocellular carcinoma

A Phase II study of TSU-68 in patient with hepatocellular carcinoma who are treated by transcatheter arterial chemoembolization (TACE)

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221054

Enrollment

100

Registered

2010-04-01

Start date

2010-04-01

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

investigational material(s) Generic name etc : TSU-68 INN of investigational material : orantinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)20 years or older. 2)Histopathologically confirmed HCC or diagnosed as HCC by the CT imaging. 3)Not indicated to treatment with curative surgery or percutaneous ablation(such as RFA, PEIT or PMCT). 4)Adequate oral intake. 5)Life expectancy of at least 3 months. 6)P.S.:0-2

Exclusion criteria

Exclusion criteria: 1)Patient has ascites, pleural effusions or pericardial fluid requiring drainage . 2)Patient has clinical symptoms of hepatic encephalopathy. 3)Patient has active or uncontrolled clinically serious infection excluding chronic hepatitis . 4)Patient has active double cancer. 5)Have participated in other clinical trials within 4 weeks prior to registration.

Design outcomes

Primary

Measure	Time frame
PFS:Progression Free Survival Tumor response by RECIST	—

Secondary

Measure	Time frame
1)Frequency and type of Adverse events and Drug-related adverse events 2)Overall Survival Safety by CTCAE Ver.3.0	—

Outcome results

None listed

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