Skip to content
Triangle logo TriangleGet started
← Primary Liver Cancer

HEALTH PROFESSIONAL · SOURCE READING

Sorafenib

Source: Primary Liver Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: April 17, 2025 · Captured 2026-09-09.

Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary.

Context: Treatment of Locally Advanced or Metastatic Primary Liver Cancer / Treatment Options for Locally Advanced or Metastatic Primary Liver Cancer / First-line systemic therapy / Targeted therapy (multikinase inhibitors)

Evidence (sorafenib):

The SHARP trial (NCT00105443) randomly assigned 602 patients with advanced HCC to receive either sorafenib 400 mg twice daily or a placebo. All but 20 of the patients had a Child-Pugh class A liver disease score; 13% were women.[15]

Source links and citations

The SHARP trial (NCT00105443) randomly assigned 602 patients with advanced HCC to receive either sorafenib 400 mg twice daily or a placebo. All but 20 of the patients had a Child-Pugh class A liver disease score; 13% were women.[15]

The study was stopped at the second planned interim analysis, after 321 deaths. The median survival was significantly longer in the sorafenib group than the placebo group (10.7 months vs. 7.9 months; HR favoring sorafenib, 0.69; 95% CI, 0.55–0.87; P < .001).

A subsequent, similar trial was conducted in 23 centers in China, South Korea, and Taiwan. The study included 226 patients (97% with Child-Pugh class A liver function), and twice as many patients were randomly assigned to sorafenib than to placebo.[16]

Source links and citations

A subsequent, similar trial was conducted in 23 centers in China, South Korea, and Taiwan. The study included 226 patients (97% with Child-Pugh class A liver function), and twice as many patients were randomly assigned to sorafenib than to placebo.[16]

The median OS was 6.5 months for the sorafenib group versus 4.2 months for the placebo group (HR, 0.68; 95% CI, 0.50–0.93; P = .014).

Adverse events attributed to sorafenib in both of these trials included hand-foot skin reaction and diarrhea.[15,16]

Source links and citations

Studies are also ongoing to evaluate the role of sorafenib after TACE, with chemotherapy, or in the presence of more-advanced liver disease.

Studies cited in this source section

Source citation is not a determination that a study applies to you.

Publication references

Read the original reference and check its publication notices.

Preserved source evidence · Not medical advice