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Neoadjuvant GOLP in Resectable High-Risk Intrahepatic Cholangiocarcinoma.

Guo-Ming Shi1,2,3, Xiao-Yong Huang1, Fei Liang4

  • 1Department of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai.

The New England Journal of Medicine
|March 4, 2026
PubMed
Summary

Neoadjuvant GOLP significantly improved event-free survival in patients with high-risk intrahepatic cholangiocarcinoma. This treatment regimen, including gemcitabine-oxaliplatin, lenvatinib, and an anti-PD-1 antibody, demonstrated a manageable safety profile.

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Area of Science:

  • Oncology
  • Gastroenterology
  • Clinical Trials

Background:

  • No standard neoadjuvant treatment exists for resectable intrahepatic cholangiocarcinoma (ICC) with high recurrence risk.
  • The GOLP regimen (gemcitabine-oxaliplatin, lenvatinib, anti-PD-1 antibody) shows promise in advanced ICC and biliary tract cancers.

Purpose of the Study:

  • To evaluate the efficacy and safety of neoadjuvant GOLP in patients with resectable, high-risk intrahepatic cholangiocarcinoma.
  • To compare event-free survival (EFS) and overall survival (OS) between the neoadjuvant GOLP group and a control group receiving only surgery and adjuvant therapy.

Main Methods:

  • A phase 2-3 trial randomized 178 patients with resectable high-risk ICC 1:1 to neoadjuvant GOLP (gemcitabine-oxaliplatin plus toripalimab and lenvatinib) followed by resection, or resection alone (control).
  • All patients received adjuvant capecitabine post-surgery.
  • Primary endpoint was event-free survival; secondary endpoints included overall survival and safety.

Main Results:

  • Neoadjuvant GOLP significantly increased median event-free survival to 18.0 months versus 8.7 months in the control group (P<0.001).
  • Two-year overall survival was 79% for the neoadjuvant group and 61% for the control group (HR 0.43; P=0.005).
  • Adverse events occurred in 97% of the neoadjuvant group, with 26% experiencing grade 3+ treatment-related adverse events; no treatment-related deaths occurred.

Conclusions:

  • Neoadjuvant GOLP offers a significant improvement in event-free survival for patients with resectable high-risk ICC.
  • The regimen demonstrated a manageable safety profile, with predominantly low-grade adverse events.