NCT02631499

Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Hepatocellular
• Neoplastic Cells, Circulating

Interventions

Type	Name	Description
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
DRUG	lipiodol	lipiodol is a kind of embolization material used in TACE

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2015-12-16
• Last updated: 2015-12-22

Locations

6 sites across 1 country: China