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) Conditions
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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
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 王秀慈 無
- Chang-Fang Chiu 無
- 陳珈妤 無
- Chi-Ching Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YI-JU CHEN Division of General Surgery
- 張碧倚 Division of Radiology
- Sheng-Shun Yang 無
- 吳峯旭 Division of General Surgery
- 陳家昌 Digestive System Department
- YU-HSUAN SHIH Division of Hematology & Oncology
- HSIN-CHEN LIN Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-An Liu 無
- Pei-Chang Lee 無
- Yi-Ping Hung 無
- 姜乃榕 無
- 陳宥任 無
- I-Cheng Lee 無
- San-Chi Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chi Chou 無
- 吳教恩 無
- Chun-Nan Yeh 無
- Wei-Chen Lee 無
- Hung-Chih Hsu 無
- Chan-Keng Yang 無
- 蔡駿逸 無
- Yung-Chia Kao 無
- Wen-Chi Shen 無
- Po-Jung Su 無
- Tai-Sen Yeh 無
- 吳庭榕 無
- Tsai-Sheng Yang 無
- Ming-Mo Hou 無
- 黃文冠 無
- 曾振輝 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳志宏 無
- 吳健暉 無
- Chiun Hsu 無
- 陳柏達 無
- - - 無
- YU-YUN SHAO 無
- 何承懋 無
- TSUNG-HAO LIU 無
- 楊卿堯 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-Jui Huang 無
- 周宗慶 無
- 顏志傑 無
- 趙盈瑞 無
- 呂維勛 無
- 廖亭凱 無
- Yu-Li Su 無
- Yih-Jyh Lin 無
- Chia-Jui Yen 無
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
