Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC With Major Portal Vein Tumor Thrombosis

Sponsor
Peking University (Other)
Overall Status
Completed
CT.gov ID
NCT03009461
Collaborator
(none)
64
1
2
42.9
1.5

Study Details

Study Description

Brief Summary

According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT), but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not benefit much from sorafenib in previous studies. There is no established standard treatment for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Jun 15, 2020
Actual Study Completion Date :
Dec 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sor-HAIC group

400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.

Procedure: HAIC
Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.

Drug: Sorafenib
400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.

Active Comparator: Sor group

400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.

Drug: Sorafenib
400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.

Outcome Measures

Primary Outcome Measures

  1. Overall survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient must have histologically or clinically confirmed hepatocellular carcinoma.

  • HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein)

  • Child A class

  • Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%)

  • Absolute neutrophil count >= 1,500/mcL

  • Platelets >= 100,000/mcL

  • Hemoglobin >= 90g/L

  • Total bilirubin =< 2 X institutional upper limit of normal

  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normality

  • Creatinine =< 1.5 X institutional upper limit of normal

  • Albumin >= 30g/L

  • Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:
  • Patients who have had prior chemotherapy with Oxaliplatin or Fluorouracil or sorafenib.

  • Patient who is receiving any other investigational agents

  • Patient who have a diagnosis of hepatic encephalopathy

  • Patients who have a diagnosis of sclerosing cholangitis.

  • Patients who have a diagnosis of Gilbert's disease.

  • Patients who have clinical ascites

  • Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements

  • No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years

  • Patient who is pregnant or lactating

  • Patient Allergic to Iodine contrast medium

  • Uncontrolled severe coagulation disorders (INR < 1.5 in patients not on warfarin therapy)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Cancer Hospital Beijing Beijing China 100142

Sponsors and Collaborators

  • Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaodong Wang, MD, Chief Physician, Associate Professor, Peking University
ClinicalTrials.gov Identifier:
NCT03009461
Other Study ID Numbers:
  • MPVTT
First Posted:
Jan 4, 2017
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiaodong Wang, MD, Chief Physician, Associate Professor, Peking University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021