Cholangiocarcinoma – Imfinzi plus Gemzar and Cisplatin


Biliary tract cancer is a group of malignancies that includes intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of Vater cancer.

It is typically diagnosed at advanced stages for which curative surgery is not feasible and prognosis is poor.

Patients with advanced biliary tract cancer have a poor prognosis, and first-line standard of care (Gemzar plus Cisplatin) has remained unchanged for more than 10 years.

The TOPAZ-1 trial evaluated Imfinzi plus chemotherapy for patients with advanced biliary tract cancer.


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.


685 patients were randomly assigned to Imfinzi or placebo with chemotherapy.

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 24-month survival rate (still alive) was 24.9% for Imfinzi and 10.4% for placebo.

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.


Imfinzi plus chemotherapy significantly improved survival versus placebo plus chemotherapy.

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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 Read more about Cholangiocarcinoma >>

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 cancer develops in a small liver tube that carries the bile and reaches the gallbladder. Bile duct cancer accounts for 10-20 percent of all liver cancers.

This is an aggressive cancer, as most patients are diagnosed with advanced disease, where the disease is usually incurable.

The life expectancy of the patient is bleak and lasts for about 3 years, with the support of the standard treatments.

Cholangiocarcinoma - Imfinzi plus Gemzar and Cisplatin
Cholangiocarcinoma – Imfinzi plus Gemzar and Cisplatin

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