Last updated 4 days ago

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

750 patients around the world
Available in Spain, Brazil, United States
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.
AstraZeneca
750Patients around the world

This study is for people with

Bile Duct Cancer

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) after macroscopically complete resection (R0 or R1)
Provision of a tumor sample collected at surgical resection.
Randomization within 12 weeks after resection with adequate healing and removal of drains.
Confirmed to be disease-free by imaging within 28 days prior to randomization.
Eastern Cooperative Oncology Group performance status of 0 or 1
Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
Any anti-cancer therapy for BTC prior to surgery
Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
Current or prior use of immunosuppressive medication within 14 days before the first dose
Thromboembolic event within 3 months
Active HBV or HCV infection unless treated.
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