drugset / Trial / NCT04523402

Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma With High Predict Risk of Lymph Node Metastasis

NCT04523402 ↗

Phase 2 Unknown 100 enrolled Eastern Hepatobiliary Surgery Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

A randomized controlled, open label, phase II clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma (ICC) with high risk of lymph node metastasis as evaluated by our previously established radiomics model, which has low postoperative recurrence-free survival. In this study, we aim to compare the prognosis of ICC patients who undergo liver resection (LR) following preoperative oxaliplatin and gemcitabine (GEMOX) neoadjuvant therapy (experimental arm) versus LR alone (control arm).

Timeline

Start
2020-12-31
Primary completion
2022-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —