Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
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: Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU).
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Liver Transplantation. 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
Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death worldwide. Liver transplantation (LT) is the best curative treatment of HCC meeting Milan/UCSF criteria. Milan (solitary tumour \<5cm, or up to 3 tumours, each \<3cm) and University of California San Francisco (UCSF) criteria (solitary tumour ≤6.5cm, up to 3 tumours with none \>4.5cm, and total tumour diameter ≤8cm) provide the benchmark requirements for LT, at which a 5-year survival of \>70% and recurrence rate ranging from 5-15% can be achieved. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Neo-adjuvant TAI for the HCC patients with beyond criteria serving as a down-staging method for the advanced HCC to meet Milan/UCSF criteria，and qualify for LT. This study is to compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan/UCSF Criteria HCC who underwent LT.
Interventions
- Other Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
TAI
Primary outcome measures
- OS [Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months]
Secondary outcome measures (3)
- 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]
- PFS [Time frame: From date of randomization until the date of progression, assessed up to 60 months]
Eligibility criteria
Inclusion criteria
- older than 18 years old and younger than 75 years listed for liver transplant;
- ECOG PS≤1;
- Child-Pugh Stage A or B
- Proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- Not previous treated for tumor;
- The tumor was diagnosed beyond Milan criteria or University of San Francisco criteria for LT
- 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 LT;
- Distant metastasis exits;
- Known history of other malignancy;
- Be allergic to related drugs;
- 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
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Nanjing Drum tower hospital — Nanjing
Identifiers
NCT: NCT04595864 · v1.0 20101014