The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Hepatocellular Carcinoma Clinical Trial

Official title:

The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03192618
• Other study ID #: B2017-006-01
• Status: Recruiting
• Phase: Phase 3
• First received: June 16, 2017
• Last updated: June 19, 2017
• Start date: July 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2017
• Source: Sun Yat-sen University
• Contact: Shaohua Li, MD
• Phone: +8615088064187
• Email: lishaoh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• older than 18 years old and younger than 75 years;

• ECOG PS<3;

• proven hepatocellular carcinoma with MVI according pathological examination;

• not previous treated for tumor;

• tumor was 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 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 hemorreage or cardiac/brain vascular events within 30 days;

• pregnancy;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Procedure:
• adjuvant transarterial chemoinfusion (TAI)
transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Drug:
• mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
oxaliplatin, calcium folinate, and 5-FU

Locations

Country	Name	City	State
China	Cancer Center of Sun Yat-Sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	disease-free survival	From date of randomization until the date of recurrence, assessed up to 60 months
Secondary	recurrence rate	recurrence rate	1 year, 2 year, 3 year, 5 year after surgery
Secondary	Overall survival (OS)	overall survival	From date of randomization until the date of death from any cause, assessed up to 60 months