drugset
drugset / Trial / NCT02529774

Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer

NCT02529774 ↗

Phase 2/3 Unknown 432 enrolled Ye Xu
RandomizedParallel-groupOpen-labelTreatment

Summary

This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.

Timeline

Start
2015-09
Primary completion
2020-09
Completion
2021-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 850 mg/m2 Oral
Subject Floxuridine Unknown 500 mg Other
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous
Background Dexamethasone Small molecule 1 mg Other
Background Heparin Other / unclassified 1000 iu Other

Indications

metastasis from malignant tumor of colon