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NCT03971201

A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion

Status unknown Phase 2 Last updated 14 April 2021
What this trial tests

Phase 2 trial testing hepatic resection in Hepatocellular Cancer in 200 participants. Status unknown.

Timeline
6 September 2019
Primary endpoint
31 December 2022
30 June 2023

Quick facts

Lead sponsorWhite Plains Hospital
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment200
Start date6 September 2019
Primary completion31 December 2022
Estimated completion30 June 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

White Plains Hospital

Who can join

18 and older, any sex, with Hepatocellular Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with HCC with portal vein involvement not involving the bifurcation (vP1-vP3) and no evidence of extra-hepatic spread will be enrolled. Patients will be required to have Child's A liver function and no significant portal hypertension. Patients will be randomly assigned with a 1:1 ratio to either surgery followed by adjuvant sorafenib or sorafenib alone. Patients will be followed by serial imaging. The primary end-point is overall survival.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy of Local Treatments for Hepatocellular Carcinoma Involving the Inferior Vena Cava and/or Right Atrium.
    Lee HA, Rim CH. · · 2020 · cited 6× · PMID 33376712 · DOI 10.2147/jhc.s285357
  2. Advancing Adjuvant Immunotherapy in Hepatocellular Carcinoma: A Comprehensive Review.
    Akabane M, Chatzipanagiotou OP, Imaoka Y, Schenk A, et al · · 2025 · cited 1× · PMID 40589998 · DOI 10.2147/itt.s528709

Verify or expand the search:

Other trials of hepatic resection

Trials testing the same drug.

Other recruiting trials for Hepatocellular Cancer

Currently open trials in the same condition.

Other White Plains Hospital trials

Trials by the same sponsor.

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Data sources for this page

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