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NCT Number: NCT03009461

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HAIC

Procedure

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.

Sorafenib

Drug

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

Primary outcomes

  1. Overall survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion with Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 4, 2017
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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