Clinical Trials List
2023-10-01 - 2030-12-31
Phase III
Recruiting8
ICD-10C24.9
Malignant neoplasm of biliary tract, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9156.9
Malignant neoplasm of biliary tract, part unspecified
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 (ARTEMIDE-Biliary01)
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2024/07/04
Investigators and Locations
Co-Principal Investigator
- Chi-Ching Chen 無
- 陳珈妤 無
- 王秀慈 無
- Chang-Fang Chiu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Pei-Chang Lee 無
- Yi-Ping Hung 無
- I-Cheng Lee 無
- San-Chi Chen 無
- 姜乃榕 無
- 陳宥任 無
- Chien-An Liu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
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
Exclusion Criteria
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.
The Estimated Number of Participants
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Taiwan
52 participants
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Global
750 participants
