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The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03192644
Enrollment
162
Registered
2017-06-20
Start date
2017-07-01
Completion date
2024-12-31
Last updated
2017-06-20

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 recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.

Interventions

PROCEDURETAI

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

PROCEDURETACE

transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol

DRUGepidoxorubicin and cisplatin and lipiodol

epidoxorubicin and cisplatin and lipiodol

DRUGmFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

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\<3; * proven hepatocellular carcinoma with PVTT according pathological examination; * not previous treated for tumor; * tumor and tumor thrombosis were removed in operation; * no recurrence occurence at 4 to 7 weeks after surgery; * the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3; * sign up consent; * unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion criteria

* cannot tolerate TACE or TAI; * CNS or bone 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
recurrence-free survival (RFS)From date of randomization until the date of recurrence, assessed up to 60 monthsrecurrence-free survival

Secondary

MeasureTime frameDescription
recurrence rate1 year, 2 year, 3 year, 5 year after surgeryrecurrence rate
Overall survival (OS)From date of randomization until the date of death from any cause, assessed up to 60 monthsoverall survival

Countries

China

Contacts

Primary ContactLi Shaohua, MD
lishaoh@sysucc.org.cn+86

Outcome results

None listed

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