Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment after Resection of Biliary Tract Cancer with Curative Intent
A Study On:
Liver
Study Description
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
Eligibility
Participant must be at least 18 years of age at the time of signing the informed consent form
Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic CCA or muscle invasive GBC) who have undergone macroscopically complete resection with curative intent (R0 or R1).
-Minimum body weight of ≥ 30 kg.
-Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
-Inability to swallow oral chemotherapy or other condition that would preclude adequate absorption, distribution, metabolism, or excretion of capecitabine or S-1.
-Major surgical procedure other than for resection of BTC or significant traumatic injury within 4 weeks of the first dose of rilvegostomig or an anticipated need for another major surgery during the study.
Interested in Participating in this Trial?
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Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
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