Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Johnson & Johnson Medical, China; Shanghai Zhongshan Hospital
• Treatments: Epirubicin; Ethiodized Oil

Criteria

Inclusion Criteria:

• HCC patients received curative hepatectomy with negative resection margin

• Age from 18 to 75

• Child-Pugh class A

• ASA class I to II

• ECOG performance status Grade 0 or 1

• Preoperative CTC level ≥2 per 7.5 ml peripheral blood

• No residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy

Exclusion Criteria:

• Patients diagnosed with other types of malignancies besides HCC

• Patients receiving concomitant local ablation or previous TACE

• Main portal vein tumor thrombus extraction during hepatectomy

• Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors.

• Presence of extra-hepatic or lymphatic metastasis

• Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L

• Renal impairment with creatinine > 200micromol/L

• Severe concurrent medical illness persisting > 6 weeks after hepatectomy

• History of other cancer

• Hepatic artery anomaly making TACE not possible

• Allergy to 5-Fluorouracil, Epirubicin or lipiodol

• Pregnant woman

• Informed consent not available