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February 25, 2026BMJ OpenOpen Access

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

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Authors

YCYuan ChengJXJinguo XiaYCYongquan Chi

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Overview

Phase II trial tests neoadjuvant therapy for recurrent intrahepatic cholangiocarcinoma, suggesting manageable safety and effectiveness.

Key Points

  • This trial aims to evaluate the feasibility of a combination treatment for high-risk recurrent intrahepatic cholangiocarcinoma.
  • Prospective, multicenter, phase II trial design
  • Thirty patients with resectable ICC will be enrolled in China
  • Neoadjuvant treatment includes HAIC-GEMOX, lenvatinib, and Adebrelimab for 2-4 cycles
  • Post-treatment assessments will determine surgery eligibility
  • Secondary endpoints focus on safety, resection rates, and survival outcomes
  • Primary endpoint is the completion rate of study treatment
  • Secondary endpoints will measure safety, R0 resection rate, and overall survival
  • Exploratory endpoints include analysis of the immune microenvironment

Cite This Study

Cheng et al. (2026) studied this question.

synapsesocial.com/papers/699e90eff5123be5ed04e323https://doi.org/10.1136/bmjopen-2025-101101
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