Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

Qingdao Central Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Liver Cancer

Treatments: Other: Best Supportive Care; Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT01932385

QCH20130823

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

86 participants in 2 patient groups

sorafenib

Experimental group

Description:

sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.

Treatment:

Drug: Sorafenib

Other: Best Supportive Care

Best Supportive Care

Active Comparator group

Description:

treatment mainly on nutrition and symptoms control

Treatment:

Other: Best Supportive Care