Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China

Conditions
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Carcinoma, Hepatocellular, Neoplastic Cells, Circulating

Intervention / Treatment
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* Procedure: TACE
* Drug: Epirubicin
* Drug: lipiodol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant TACE<br>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. | Procedure: TACE<br>* TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.<br>* Other names: Chemoembolization;Drug: Epirubicin<br>* Epirubicin is a chemotherapy drug used in TACE<br>* Other names: EADM;Drug: lipiodol<br>* lipiodol is a kind of embolization material used in TACE<br>* Other names: Ultra-fluid lipiodol;|
| No Intervention: Control<br>no interventions were assigned after hepatectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early recurrence rates | Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy. | 1 year after hepatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | OS was defined as the interval from date of HCC resection to death due to any cause. | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating Tumor Cells, Hepatoectomy, TACE, prognosis, relapse, Chemoembolization, Therapeutic