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NCT03368651RecruitingPhase 3

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.

Source: ClinicalTrials.gov · Last updated 11 Dec 2017 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
230 (estimated)
First submitted
4 Dec 2017
Start date
1 Jan 2016
Primary completion date
30 Nov 2026
Lead sponsor
Sun Yat-sen University
NCT number
NCT03368651

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 230
  • From 1 Jan 2016 to the primary completion date, 30 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • cannot tolerate TAI or surgery;
  • underwent organ transplantation before;

Other illness

  • known history of other malignancy;
  • be allergic to related drugs;
  • known history of HIV infection;
  • known history of drug or alcohol abuse;
  • have GI hemorrhage or cardiac/brain vascular events within 30 days;

Other

  • distant metastasis exits;
  • be treated before (interferon included);
  • pregnancy;

Who the study is looking for

  • 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;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cancer center of Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.