It is typically diagnosed at advanced stages for which curative surgery is not feasible and prognosis is poor.
In this phase 3 study, patients with previously untreated unresectable or metastatic biliary tract cancer or with recurrent disease, received Imfinzi or placebo in combination with Gemzar plus cisplatin for up to eight cycles.
The eight cycles were followed by Imfinzi or placebo monotherapy until disease progression or unacceptable toxicity.
At the time of the analysis, 198 patients in the Imfinzi group and 226 patients in the placebo group had died.
The risk of death during the treatment with Imfinzi decreased by 20%.
The risk for disease progression decreased by 25% during the treatment.
26.7% of patients with Imfinzi responded to the treatment vs 18.7% with placebo.
The incidences of harsh to severe side effects were 75.7% and 77.8% with Imfinzi and placebo, respectively.
With Imfinzi, more patients responded, and the risks of death and disease progression were decreased.
The safety profiles of the two treatment groups were similar.
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Cholangiocarcinoma is a gallbladder and biliary tract cancer and is the second most common liver tumor. The disease is created when cancer cells develop in the tissues that build the gallbladder and the biliary tract.
The life expectancy of the patient is bleak and lasts for about 3 years, with the support of the standard treatments.