Biliary Tract Cancer Clinical Trial
Official title:
DKN-01/Atezolizumab as Second Line Treatment of biliarY Tract Cancer and in combiNAtion or Not With Paclitaxel as Second Line treatMent of esophagogastrIC Cancer: a Multi-center Phase II Trial
In this study, non-operable esophagogastric adenocarcinoma cancer patients or non-operable
biliary cancer patients who's cancer progressed/spread/got worse after first line treatment
will be treated with a novel combination of immunotherapy and/or chemotherapy. This study
will take place in several countries across Europe. One hundred twenty-three (123) patients
will be invited to participate in this study
Biliary tract cancer (BTC), is a form of cancer that start in your bile ducts, a series of
tubes that runs from the liver to the small intestines. It is not know yet the exact cause of
BTC. For patients who have advanced or metastatic BTC (where surgery is not possible),
chemotherapy is the first option for treatment. Chemotherapy with cisplatin and gemcitabine
(CisGem) is the current standard of care.
Esophageal cancer (EGC) is cancer that occurs in the esophagus, a long hollow tube that runs
from your throat to your stomach. The accumulating abnormal cells form a tumor in the
esophagus that can grow to invade nearby structures and spread to other parts of the body.
It's thought that chronic irritation of your esophagus may contribute to the changes that
cause esophageal cancer.
The purpose of this study is to look at the risks and benefits of combining DKN-01 (humanized
monoclonal antibody) and atezolizumab (immune therapy) with or without paclitaxel
(chemotherapy). Immune therapy boosts the body's natural defenses to fight cancer. It uses
specific products made either by participants' body or in a laboratory to improve, target or
restore immune system function and control or stop cancer. Atezolizumab is such
"immunotherapy" drug. DKN-01 is another new type of drug (humanized monoclonal antibody) in
development as anticancer agent. Paclitaxel is a commonly-used chemotherapy drug of the class
of taxanes used to treat a number of cancer types, it stimulates the cell to die or to stop
the cell from dividing into two new cells.The idea behind combining these drugs is linked to
targeting the immune system to attack the tumor. Combining immune and chemotherapy already
demonstrated clinical activity in relapsed (return of the disease)/refractory (not responding
to treatment) esophagogastric cancer patients.
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