EichorEICHOR
Study identifier: NCT07691515 Synced from ClinicalTrials.gov · August 03, 2026
● Not Yet Recruiting

Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

Condition: Intrahepatic Cholangiocarcinoma (Icc)  ·  Sponsor: Zhejiang Cancer Hospital

PhasePhase 3
Planned participants140
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

Talk to the study team

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.

Locations (18)

The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, Guangdong, China
Jinshazhou Hospital of Guangzhou University of Chinese MedicineGuangzhou, Guangdong, China
Guangdong Second People's HospitalGuangzhou, Guangdong, China
The Affiliated Panyu Central Hospital of Guangzhou Medical UniversityGuangzhou, Guangdong, China
The Second Affiliated Hospital of Guangdong Medical UniversityGuangzhou, Guangdong, China
Jiangmen Central HospitalJiangmen, Guangdong, China
Wuhan Union Hospital of ChinaWuhan, Hubei, China
The Second Xiangya Hospital of Central South UniversityChangsha, Hunan, China
The Third Xiangya Hospital of Central South UniversityChangsha, Hunan, China
Ganzhou Hospital-Nanfang Hospital, Southern Medical UniversityGanzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang UniversityNanchang, Jiangxi, China
The Affiliated Hospital of QingDao UniversityQingdao, Shandong, China

+ 6 more locations — full list on the registry record.

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