Clinical Trials List
2025-11-07 - 2029-09-25
Phase III
Recruiting8
ICD-10C26.9
Malignant neoplasm of ill-defined sites within the digestive system
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9159.9
Malignant neoplasm of ill-defined sites within the digestive organs and peritoneum
Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)
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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
2026/04/08
Investigators and Locations
Co-Principal Investigator
- Yi-Ping Hung 無
- Hung-Yuan Yu 無
- 齊振達 無
- 唐振育 無
- 姜乃榕 無
- San-Chi Chen 無
- 邱乃祈 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鄭富銘 無
- Chi-Ching Chen 無
- 王秀慈 無
- 陳珈妤 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Po-Jung Su 無
- Chan-Keng Yang 無
- Hung-Chih Hsu 無
- Ming-Mo Hou 無
- 黃文冠 無
- 余紹銘 無
- Yung-Chia Kao 無
- Wen-Chi Shen 無
- Wen-Chi Chou 無
- 黃振洋 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kuan-Der Lee 無
- HSIN-CHEN LIN 無
- 楊陽生 無
- YU-HSUAN SHIH 無
- ZHENG-WEI ZHOU 無
- Cheng-Lun Lai 無
- 曾貫宇 無
- 吳承翰 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 郭弘揚 無
- 陳柏邑 無
- YU-YUN SHAO 無
- Chiun Hsu 無
- 林宗哲 無
- TSUNG-HAO LIU 無
- 呂理駿 無
- Ying-Chun Shen 無
- 莊建淮 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Meng-Jer Hsieh 無
- 柯建佑 無
- 蔡郁棻 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Durvalumab
Dosage Form
270
Dosage
500mg/vial
Endpoints
Inclution Criteria
Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.
Adequate bone marrow and organ function.
Exclusion Criteria
Ampullary carcinoma
Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
The Estimated Number of Participants
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Taiwan
97 participants
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Global
1100 participants
