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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Biliary Tract Cancer

In brief

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.

Key facts

Study ID

NCT06109779

Run by

AstraZeneca

People needed

760

Starts

2023-12-04

Expected to finish

2030-05-03

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Nanchang, China
• Research Site — Nanjing, China
• Research Site — Nanjing, China
• Research Site — Nanning, China
• Research Site — Shandong, China
• Research Site — Shanghai, China
• Research Site — Shenyang, China
• Research Site — Tianjin, China
• Research Site — Wuhan, China
• Research Site — Wuhan, China
• Research Site — Xi'an, China
• Research Site — Zhengzhou, China
• Research Site — Herlev, Denmark
• Research Site — Marseille, France
• Research Site — Montpellier, France
• Research Site — Pessac, France
• Research Site — Rennes, France
• Research Site — Strasbourg, France
• Research Site — Toulouse, France
• Research Site — Villejuif, France
• Research Site — Berlin, Germany
• Research Site — Bonn, Germany
• Research Site — Dortmund, Germany
• Research Site — Dresden, Germany
• Research Site — Lishui, China

Full record on ClinicalTrials.gov

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