Recruiting 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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TAI.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.
Interventions
- Procedure TAI
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Primary outcome measures
- Overall survival (OS) [Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months]
Secondary outcome measures (2)
- recurrence-free survival (RFS) [Time frame: From date of randomization until the date of recurrence, assessed up to 60 months]
- recurrence rate [Time frame: 1 year, 2 year, 3 year, 5 year after surgery]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Center of Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT03368651 · B2017-076-01