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.

NCT ID: NCT03192644

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2024-12-31

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (TAI)

Group Type: EXPERIMENTAL

TAI

Intervention Type: PROCEDURE

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

mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Intervention Type: DRUG

oxaliplatin, calcium folinate, and 5-FU

Group B (TACE)

Group Type: ACTIVE_COMPARATOR

TACE

Intervention Type: PROCEDURE

transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol

epidoxorubicin and cisplatin and lipiodol

Intervention Type: DRUG

epidoxorubicin and cisplatin and lipiodol

Interventions

TAI

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

Intervention Type: PROCEDURE

TACE

transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol

Intervention Type: PROCEDURE

epidoxorubicin and cisplatin and lipiodol

epidoxorubicin and cisplatin and lipiodol

Intervention Type: DRUG

mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

oxaliplatin, calcium folinate, and 5-FU

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Rong-ping Guo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Center of Sun Yat-Sen University

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Shaohua, MD

Role: CONTACT

lishaoh@sysucc.org.cn

+86

Facility Contacts

Shaohua Li, MD

Role: primary

lishaoh@sysucc.org.cn

Other Identifiers

B2017-004-01

Identifier Type: -

Identifier Source: org_study_id