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OpenTrials
Completed

NCT Number: NCT01932385

Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

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.

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Key information

Conditions

Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib

Drug

Other names: Nexavar

Best supportive care

Other

Primary outcomes

  1. progression free survival and overall survival

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause up to 12 months

Secondary outcomes

  1. response rate

    Time frame: every 4 weeks till progression, total up to 12 months

Sponsors and collaborators

Lead sponsor

Qingdao Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2013
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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