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NCT01932385 Clinical Trial

Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

Liver Cancer Clinical Trial

Official title:
Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01932385
Other study ID # QCH20130823
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 22, 2013
Last updated February 13, 2018
Start date August 1, 2013
Est. completion date July 30, 2016

Study information
Verified date October 2015
Source Qingdao Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date July 30, 2016
Est. primary completion date January 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- pathological or cytological confirmed advanced hepatocellular carcinoma

- 18 years to 80 years

- liver function Child-Pugh class B

- BCLC stage B or C

- estimated life time 2 months or longer

Exclusion Criteria:

- previous target therapy

- allergy to Sorafenib

- Uncontrolled Bleeding or diarrhea

- eligible for locoregional treatment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sorafenib

Other:
• Best Supportive Care

Locations
Country Name City State
China Qingdao Central Hospital, Qingdao Cancer Hospital Qingdao Shandong

Sponsors (1)
Lead Sponsor Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression free survival and overall survival From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
Secondary response rate every 4 weeks till progression, total up to 12 months
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