Carcinoma, Hepatocellular, Neoplastic Cells, Circulating
Conditions
Keywords
Circulating Tumor Cells, Hepatoectomy, TACE, prognosis, relapse, Chemoembolization, Therapeutic
Brief 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.
Detailed 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.
Interventions
DRUGlipiodol
lipiodol is a kind of embolization material used in TACE
PROCEDURETACE
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
DRUGEpirubicin
Epirubicin is a chemotherapy drug used in TACE
Sponsors
Shanghai Zhongshan Hospital
Johnson & Johnson Medical, China
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early recurrence rates | 1 year after hepatectomy | Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | up to 3 years | OS was defined as the interval from date of HCC resection to death due to any cause. |
Countries
China
Contacts
Primary ContactXin-Rong Yang, MD & PhD
Backup ContactYun-Fan Sun, MD & PhD
Outcome results
None listed