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

NCT03971201 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-04-14

No results posted yet for this study

Summary

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.

Conditions

  • Hepatocellular Cancer

Interventions

PROCEDURE

hepatic resection

removal of portion of liver containing cancer

DRUG

Sorafenib

sorafenib either as adjuvant therapy after resection or as only treatment

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Cancer Hospital of Guangxi Medical University

    collaborator OTHER

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Wenzhou People's Hospital

    collaborator OTHER

  • White Plains Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2022-12-31
Completion
2023-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03971201 on ClinicalTrials.gov