US FDA approves nivolumab for liver cancer treatment


Previously, hepatocellular carcinoma (HCC) have been confined to surgery, chemoembolization and limited targeted therapies, such as sorafenib and regorafenib, and therefore additional treatment options are necessary. Nowadays, immunotherapeutic agents have been approved for different cancer types, opening a new chapter for new era of cancer treatment and may shed light for liver cancer treatment. Based on the results of phase I/II checkmate-040 trial, US FDA have approved nivolumab, a PD-1 (programmed death-1) checkpoint inhibitor, for the treatment of hepatocellular carcinoma patients, who have been previously treated with sorafenib. The phase I/II checkmate-040 trial recruited 154 HCC patients who were administered sorafenib. The overall response rate is 14.3% (95% CI: 9.2-20.8, 22/154). Among responders, 19 partial responses (12.3 %) and three complete responses (1.9 %) were observed. Moreover, most responders (91%) exhibited response of six months or longer. In conclusion, nivolumab will become a promising new treatment option for patients with hepatocellular carcinoma treatment.

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