Sorafenib Combined With Aspirin to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title: A Prospective Randomized Control Trial of the Effect of Sorafenib Combined With Aspirin in Preventing the Recurrence in High-risk Patients With Hepatocellular Carcinoma

Status Terminated

Clinical Trial Summary

The purpose of the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

Clinical Trial Description

The recurrence of hepatocellular carcinoma(HCC）is the main problem during the treatment. Although some methods such as interferon may be effective in preventing the recurrence, there is still no clear effective approach widely accepted for everyone.

Sorafenib, a kind of tyrosine kinase inhibitor, which inhibiting proliferation and inducing apoptosis of tumor cell by inhibiting the raf/MEK/ERK pathway, and anti-angiogenesis by targeting Vascular Endothelial Growth Factor Receptor(VEGFR), has now become the standard treatment of advanced HCC patients. Although the STORM studies have shown that adjuvant sorafenib for such patients did not significantly affect recurrence-free survival, time to recurrence, or overall survival. The patients recruiting in the study were mostly early stage, for middle and late stage patients, whether sorafenib can reduce tumor recurrence after surgical resection and prolong survival remains to be further study.

Aspirin is a kind of nonsteroidal anti-inflammatory drugs. It is the first hint of aspirin's potential role in tumor prevention and treatment when Gasic found that tumor metastasis is reduced in thrombocytopenia mice, and then the research confirmed that aspirin treatment can significantly reduce the tumor metastasis. In recent years, a lot of epidemiological evidence and clinical trials found that aspirin played an important role in cancer prevention, at the same time, more experimental study has found that it can also play a role in tumor treatment. Our previous animal experiments found that a combination of sorafenib and aspirin can reverse the negative effect of sorafenib which promoted tumor metastasis, and obviously prolong survival of a tumor-burdened nude mice.

So, the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with hepatocellular carcinoma. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

• NCT number: NCT02748304
• Study type: Interventional
• Source: Fudan University
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Completion date: February 11, 2019