CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 247 enrolled
Drug / intervention
Sorafenib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02774187
NCT02774187Phase 3Completed
CompareCT.gov

Sorafenib Alone Versus Sorafenib Combined With Hepatic Arterial Chemoinfusion for Advanced HCC With Portal Vein Tumor Thrombosis: a Multicentre Randomised Controlled Trial

Sun Yat-sen University·interventional·Posted May 17, 2016·Updated Dec 5, 2019

In Brief

A Phase 3 clinical trial evaluating Sorafenib, Hepatic arterial infusion chemotherapy, and 1 other intervention for Hepatocellular Carcinoma. Completed, enrolled 247 participants across 5 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesChina
CollaboratorsFirst Affiliated Hospital, Sun Yat-Sen University, Kaiping Central Hospital, Guangzhou No.12 People's Hospital, The First Affiliated Hospital of University of South China

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 17, 2016
Enrollment StartMay 1, 2016
Primary CompletionJul 1, 2017
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.1 years ago

Interventions

Sorafenibdrug

administration of Sorafenib

Hepatic arterial infusion chemotherapyprocedure

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Folfox Protocoldrug

Oxaliplatin , fluorouracil, and leucovorin