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Efficacy and safety of vitamin K + lenvatinib combination treatment against hepatocellular carcinoma:a randomised,open label,phase 2 trial

Efficacy and safety of vitamin K + lenvatinib combination treatment against hepatocellular carcinoma:a randomised,open label,phase 2 trial - Vitamin K + lenvatinib combination treatment against HCC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033027
Enrollment
60
Registered
2018-06-17
Start date
2018-06-17
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

lenvatinib(12mg or 8mg, daily) alone treatment, continued if neither severe adverse events nor disease progression is seen lenvatinib(12mg or 8mg, daily)+vitamin K(45mg, daily) combination treatment,

Sponsors

Departments of Laboratory Medicine and Gastroenterology & Hepatology, Osaka General Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ECOG performance status: 0 or 1 Child-Pugh score: 8 or less suffering with osteoporosis Written consent is obtained.

Exclusion criteria

Exclusion criteria: dosed with warfarin

Design outcomes

Primary

MeasureTime frame
progression free survival(evaluated by modified RECIST)

Secondary

MeasureTime frame
overall survival safety (comparison in adverse event incidence)

Countries

Japan

Contacts

Public ContactYoshimichi Haruna

Osaka General Medical Center Departments of Laboratory Medicine and Gastroenterology & Hepatology

apple-123-grape@ab.auone-net.jp06-6692-1201

Outcome results

None listed

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