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A Phase I study of TSU-68 in combination with S-1 in patients with advanced hepatocellular carcinoma who are not candidates for conventional therapy

A Phase I study of TSU-68 in combination with S-1 in patients with advanced hepatocellular carcinoma who are not candidates for conventional therapy

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221925
Enrollment
18
Registered
2012-09-25
Start date
2012-09-25
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, S-1 INN of investigational material : orantinib, tegafur, gimeracil, oteracil potassium Therapeutic category code : 42- Antineoplastic agents Dos

Sponsors

Taiho Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Age >=20 - ECOG performance status 0-1 - Patients who did not respond to surgery, RFA, TAE

Exclusion criteria

Exclusion criteria: - Large amount of pleural effusion or ascites - Esophageal varices - Simultaneously active double cancer

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
Time to progression, Response rate, Overall survival

Outcome results

None listed

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