Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Trial design Surgery + sorafenib vs. sorafenib 100 patients per arm Centralized randomization by CRO Need to call CRO for treatment allocation Primary end-point - OS Secondary end-point Progression free survival (PFS) Randomized 1:1 Stratification Vp1-2 vs. Vp3 AFP ≤400 vs AFP >400 Intention to treat Surgery aborted or R1-2 resection will remain in surgical arm No cross over CT scan chest/abdomen 4 weeks after surgery as post-operative baseline Will not alter treatment allocation Will allow for PFS measurement in surgical arm CT scan chest/abdomen pelvis Q 12 weeks after initiation sorafenib Patients progressing on sorafenib allowed 2nd line treatment Regorafenib or lenvatinib - if approved in China Dose reduction sorafenib as per protocol ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03971201
Study type Interventional
Source White Plains Hospital
Contact Wei-Hua Guan, MD
Phone +8613501673307
Email weiyu.wang@tigermed.net
Status Recruiting
Phase Phase 2
Start date September 6, 2019
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04484636 - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) N/A
Recruiting NCT05489250 - The PLATON Network
Completed NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer Phase 2
Terminated NCT00878215 - Clinical Application of Image-Guided Liver Surgery Phase 2
Completed NCT04212286 - Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC N/A
Recruiting NCT05992220 - Atezolizumab Plus Bevacizumab Alone or Combined With External Beam Radiotherapy for HCC With Macrovascular Invasion Phase 2
Completed NCT02073435 - A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation
Active, not recruiting NCT01522937 - A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer Phase 2
Terminated NCT05061537 - Study of PF-07263689 in Participants With Selected Advanced Solid Tumors Phase 1
Active, not recruiting NCT04166240 - Measuring and Improving the Safety of Test Result Follow-Up N/A
Withdrawn NCT02288507 - Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer Phase 1
Terminated NCT03026803 - A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer Phase 2
Active, not recruiting NCT04682847 - Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers
Active, not recruiting NCT05100082 - Survey of Cabozantinib Tablets Used To Treat People With Hepatocellular Carcinoma
Active, not recruiting NCT03195699 - Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers Phase 1
Completed NCT02616692 - HCC Patient Preferences in Japan N/A
Active, not recruiting NCT03132792 - AFPᶜ³³²T in Advanced HCC Phase 1
Recruiting NCT01849588 - Sorafenib for Hepatocellular Cancer With Chronic Hepatitis C Phase 4
Completed NCT00997022 - Trial of Sorafenib in Hepatocellular Cancer (HCC) Transplant Patients Phase 1
Suspended NCT00909558 - Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer Phase 1