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A phase I/II study in combination of YHI-1001 and Sorafenib in patients with advanced hepatocellular carcinoma previously untreated with systemic chemotherapy

A phase I/II study in combination of YHI-1001 and Sorafenib in patients with advanced hepatocellular carcinoma previously untreated with systemic chemotherapy

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222078
Enrollment
164
Registered
2013-05-14
Start date
2013-05-14
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

patients with advanced hepatocellular carcinoma previously untreated with systemic chemotherapy

Interventions

investigational material(s) Generic name etc : YHI-1001+Sorafenib INN of investigational material : Resminostat+Sorafenib Therapeutic category code : 429 Other antitumor agents Dosage and Administrati

Sponsors

Yakult Honsha Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients with advanced or metastatic hepatocellular carcinoma (2)Patients with ECOG PS of 0-1 (3)Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications

Exclusion criteria

Exclusion criteria: (1)Patients with a history of treatment with HDAC inhibitors (2)Pregnant women and lactating mothers (3)Patients with brain metastases or suspected brain metastases based on the clinical symptoms

Design outcomes

Primary

MeasureTime frame
PI:Safety PII:Efficacy

Secondary

MeasureTime frame
PI:PK PII:Safety

Outcome results

None listed

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