A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.

A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma. - A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014566

Enrollment

250

Registered

2014-07-16

Start date

2014-07-08

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

Dose re-escalation of sorafenib from reduce dose Continued sorafenib with reduce dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20 years or more 2) Presence of histologically confirmed or clinically diagnosed hepatocellular carcinoma 3) Absence of benefit from a treatment of established efficacy, such as resection, local ablation, and transarterial chemoembolization 4) Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 5) Presence of Child-Pugh score 7 or less

Exclusion criteria

Exclusion criteria: 1) History of a primary tumor diagnosed in the past 3 years 2) Presence of active bacterial infections, HIV/AIDS, or other diseases that would preclude study participation 3) Presence of uncontrolled or significant cardiovascular disease 4) Regular phenytoin or warfarin use 5) Presence of mental incapacity or psychiatric illness.

Design outcomes

Primary

Measure	Time frame
Time to progression after randomization	—

Secondary

Measure	Time frame
Overall Survival Overall survival after randomization; OS after randomization Time to progression Drug concentration of sorafenib Safety	—

Countries

Japan

Contacts

Public ContactSadahisa Ogasawara

Chiba university hospital Department of Gastroenterology

sadahisa@me.com043-222-7171

Outcome results

None listed

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