FindTrial
Sign In

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.

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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03368651
Enrollment
230
Registered
2017-12-11
Start date
2016-01-01
Completion date
2028-12-31
Last updated
2017-12-11

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 HCC and PVTT who underwent hepatectomy.

Interventions

PROCEDURETAI

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

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Overall survival (OS)From date of randomization until the date of death from any cause, assessed up to 60 monthsoverall survival

Secondary

MeasureTime frameDescription
recurrence-free survival (RFS)From date of randomization until the date of recurrence, assessed up to 60 monthsrecurrence-free survival
recurrence rate1 year, 2 year, 3 year, 5 year after surgeryrecurrence rate

Countries

China

Contacts

Primary ContactShaohua Li, MD
lishaoh@sysucc.org.cn+8615088064187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026