The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy

The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy: A Random, Controlled, Stage III Clinical Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03851913

Enrollment

344

Registered

2019-02-22

Start date

2018-07-01

Completion date

2024-08-31

Last updated

2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.

Interventions

PROCEDURETAI

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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; * the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria; * 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.

Design outcomes

Primary

Measure	Time frame	Description
OS	From date of randomization until the date of death from any cause, assessed up to 60 months	overall survival

Secondary

Measure	Time frame	Description
RFS	From date of randomization until the date of recurrence, assessed up to 60 months	recurrence-free survival
recurrence rate	1 year, 2 year, 3 year, 5 year after surgery	recurrence rate
PFS	From date of randomization until the date of progression, assessed up to 60 months	progression free survival

Countries

China

Contacts

Primary ContactShaohua Li, MD

lishaoh@sysucc.org.cn+8615088064187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026