Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Carcinoma, Hepatocellular; Neoplastic Cells, Circulating

Treatments: Drug: lipiodol; Procedure: TACE; Drug: Epirubicin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02631499

CTC-HE-TACE

Details and patient eligibility

About

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.

Full description

Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, and associated morbidity and mortality rates have escalated in recent years. Despite improvements in surveillance and clinical treatment strategies, the prognosis of HCC remains very poor due to high incidence of recurrence and metastasis. Recent clinical studies have provided evidence that circulating tumor cell (CTC) may directly participate in the metastasis cascade in various types of malignancies. The investigators previous data indicated that HCC patients with preoperative CTC levels ≥2 suffered significantly earlier recurrence (within 1 year) than patients with lower levels. However, the benefits of postoperative adjuvant therapies in preventing early recurrence in patients with preoperative CTC ≥2 remain to be elucidated. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. The investigators design a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy to reduce early recurrence rates in HCC patients with preoperative CTC level ≥2.

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

Adjuvant TACE

Experimental group

Description:

TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.

Treatment:

Drug: Epirubicin

Procedure: TACE

Drug: lipiodol

Control

No Intervention group

Description:

no interventions were assigned after hepatectomy