Condition: Intrahepatic Cholangiocarcinoma (Icc) · Sponsor: Zhejiang Cancer Hospital
This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients with unresectable intrahepatic cholangiocarcinoma. Approximately 140 eligible patients with histologically confirmed unresectable intrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled and randomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib or GEMCIS plus tislelizumab. In the TACE-based treatment arm, hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to the protocol. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, time to progression, objective response rate, disease control rate, safety, and quality of life.
This description comes directly from the study's public registry record.
Gaojun Teng, MD · +86 13805171500 · gjteng@seu.edu.cn
Binyan Zhong, MD · +86 15850522044 · byzhongir@sina.com
Always discuss trial participation with your own doctor first.
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China | — |
| Jinshazhou Hospital of Guangzhou University of Chinese Medicine | Guangzhou, Guangdong, China | — |
| Guangdong Second People's Hospital | Guangzhou, Guangdong, China | — |
| The Affiliated Panyu Central Hospital of Guangzhou Medical University | Guangzhou, Guangdong, China | — |
| The Second Affiliated Hospital of Guangdong Medical University | Guangzhou, Guangdong, China | — |
| Jiangmen Central Hospital | Jiangmen, Guangdong, China | — |
| Wuhan Union Hospital of China | Wuhan, Hubei, China | — |
| The Second Xiangya Hospital of Central South University | Changsha, Hunan, China | — |
| The Third Xiangya Hospital of Central South University | Changsha, Hunan, China | — |
| Ganzhou Hospital-Nanfang Hospital, Southern Medical University | Ganzhou, Jiangxi, China | — |
| The First Affiliated Hospital of Nanchang University | Nanchang, Jiangxi, China | — |
| The Affiliated Hospital of QingDao University | Qingdao, Shandong, China | — |
+ 6 more locations — full list on the registry record.
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