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.

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: TAI; Procedure: TACE; Drug: epidoxorubicin and cisplatin and lipiodol; Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

• Registration Number: NCT03192644
• Lead Sponsor: Sun Yat-sen University

Brief Summary

To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Study First Posted: 2017-06-20
• Last Update Posted: 2017-06-20
• Study Start: 2017-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (TAI)	TAI	-
Group B (TACE)	epidoxorubicin and cisplatin and lipiodol	-
Group A (TAI)	mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)	-
Group B (TACE)	TACE	-

Primary Outcome Measures

Name	Time	Method
recurrence-free survival (RFS)	From date of randomization until the date of recurrence, assessed up to 60 months	recurrence-free survival

Secondary Outcome Measures

Name	Time	Method
recurrence rate	1 year, 2 year, 3 year, 5 year after surgery	recurrence rate
Overall survival (OS)	From date of randomization until the date of death from any cause, assessed up to 60 months	overall survival

Trial Locations

Locations (1)

Cancer Center of Sun Yat-Sen University; 🇨🇳 Guangzhou, China