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NCT Number: NCT03368651

The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, +86, China

Location status: Recruiting

Location contact

Shaohua Li, MD

CONTACT

[email protected]

+8615088064187

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • older than 18 years old and younger than 75 years;
  • ECOG PS≤1;
  • proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
  • not previous treated for tumor;
  • estimated tumor and tumor thrombosis could be removed en bloc in operation;
  • no distant metastasis;
  • the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
  • sign up consent;

Exclusion criteria

  • cannot tolerate TAI or surgery;
  • distant metastasis exits;
  • known history of other malignancy;
  • be allergic to related drugs;
  • underwent organ transplantation before;
  • be treated before (interferon included);
  • known history of HIV infection;
  • known history of drug or alcohol abuse;
  • have GI hemorrhage or cardiac/brain vascular events within 30 days;
  • pregnancy;

Treatment and study plan

TAI

Procedure

transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Primary outcomes

  1. Overall survival (OS)

    Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months

    overall survival

Secondary outcomes

  1. recurrence-free survival (RFS)

    Time frame: From date of randomization until the date of recurrence, assessed up to 60 months

    recurrence-free survival

  2. recurrence rate

    Time frame: 1 year, 2 year, 3 year, 5 year after surgery

    recurrence rate

Study contacts

Contact information is provided by the study sponsor or research team.

Shaohua Li, MD

CONTACT

[email protected]

+8615088064187

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2028
First posted
Dec 11, 2017
Registry last updated
Dec 11, 2017

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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