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drugset / Trial / NCT06208462

Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

NCT06208462 ↗

Phase 2 Recruiting 33 enrolled The First Affiliated Hospital with Nanjing Medical University Jiangsu Hengrui Pharmaceutical Co., Ltd. · collab

NaSingle-groupOpen-labelTreatment

Summary

Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.

Timeline

Start: 2024-01-19
Primary completion: 2026-01
Completion: 2027-01

Publications

Cheng Y, Xia J, Chi Y, Rao J, Cheng F; CLEAP China Liver Cancer Study Group Young Investigators (CLEAP). Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial. BMJ Open. 2026 Feb 23;16(2):e101101. doi: 10.1136/bmjopen-2025-101101.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adebrelimab	Monoclonal antibody	1200 mg	Intravenous
Subject	Gemcitabine	Small molecule	800 mg/m2	Other
Subject	Lenvatinib	Small molecule	8 mg	—
Subject	Oxaliplatin	Small molecule	85 mg/m2	Other

Indications