Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02631499
• Other study ID #: CTC-HE-TACE
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 9, 2015
• Last updated: December 20, 2015
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: December 2015
• Source: Fudan University
• Contact: Xin-Rong Yang, MD & PhD
• Phone: 008618616881978
• Email: yang.xinrong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Neoplastic Cells, Circulating

Intervention

Procedure:
• TACE
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.

Drug:
• Epirubicin
Epirubicin is a chemotherapy drug used in TACE
• lipiodol
lipiodol is a kind of embolization material used in TACE

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Eastern Hepatobiliary Surgery Hospital, Second Military Medical University	Shanghai	Shanghai
China	Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai
China	Zhongshan hospital, Fudan University	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Soochow	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Fudan University	Johnson & Johnson Medical, China, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Ren ZG, Lin ZY, Xia JL, Ye SL, Ma ZC, Ye QH, Qin LX, Wu ZQ, Fan J, Tang ZY. Postoperative adjuvant arterial chemoembolization improves survival of hepatocellular carcinoma patients with risk factors for residual tumor: a retrospective control study. World J Gastroenterol. 2004 Oct 1;10(19):2791-4. — View Citation

Sun YF, Xu Y, Yang XR, Guo W, Zhang X, Qiu SJ, Shi RY, Hu B, Zhou J, Fan J. Circulating stem cell-like epithelial cell adhesion molecule-positive tumor cells indicate poor prognosis of hepatocellular carcinoma after curative resection. Hepatology. 2013 Apr;57(4):1458-68. doi: 10.1002/hep.26151. Epub 2013 Mar 4. — View Citation

Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early recurrence rates	Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.	1 year after hepatectomy	No
Secondary	Overall Survival	OS was defined as the interval from date of HCC resection to death due to any cause.	up to 3 years	No