Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02631499

Collaborator

Shanghai Zhongshan Hospital (Other), Johnson & Johnson Medical, China (Industry)

256

Enrollment

Locations

Arms

Duration (Months)

42.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular Neoplastic Cells, Circulating	Procedure: TACE Drug: Epirubicin Drug: lipiodol	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adjuvant TACE 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 TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE. Other Names: Transcatheter Arterial Chemoembolization Chemoembolization Drug: Epirubicin Epirubicin is a chemotherapy drug used in TACE Other Names: EADM Drug: lipiodol lipiodol is a kind of embolization material used in TACE Other Names: Ultra-fluid lipiodol
No Intervention: Control no interventions were assigned after hepatectomy

Arm

Intervention/Treatment

Experimental: Adjuvant TACE

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

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

Other Names:

Transcatheter Arterial Chemoembolization

Chemoembolization

Drug: Epirubicin

Epirubicin is a chemotherapy drug used in TACE

Other Names:

EADM

Drug: lipiodol

lipiodol is a kind of embolization material used in TACE

Other Names:

Ultra-fluid lipiodol

No Intervention: Control

no interventions were assigned after hepatectomy

Outcome Measures

Primary Outcome Measures

Early recurrence rates [1 year after hepatectomy]
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.

Secondary Outcome Measures

Overall Survival [up to 3 years]
OS was defined as the interval from date of HCC resection to death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong	China	510000
2	Nantong Tumor Hospital	Nantong	Jiangsu	China	226000
3	The First Affiliated Hospital of Soochow University	Soochow	Jiangsu	China	215000
4	Eastern Hepatobiliary Surgery Hospital, Second Military Medical University	Shanghai	Shanghai	China	200000
5	Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai	China	200000
6	Zhongshan hospital, Fudan University	Shanghai	Shanghai	China	200000