Adjuvant TACE to Reduce the HCC Recurrence After Resection

NCT02788526 | Completed Phase 3 DMC

• 1 other identifier: SYSUCC-HCC-ADTACE
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. The conventional risk factors of recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after hepatectomy. The investigators' previous study showed that the recurrence rate is more than 50% for the patients with \>5cm solitary tumor and MVI. The MVI was confirmed as the only independent risk factor for the overall and disease-free survival of HCC patients in multiple variables analysis. It is important to reduce the recurrence and prolong the survival of patients after hepatectomy with effective adjuvant therapy. TACE has been utilized as an adjuvant therapy after hepatectomy, but its significance is still unknown. Then, the investigators design the current prospective randomized clinical trial to evaluate the effect of adjuvant TACE to reduce the recurrence in HCC patients at high risk (\>5cm solitary tumor and MVI) after resection, compared to vigilant follow-up.

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma,Hepatocellular; Chemoembolization; Adjuvant therapy; Hepatocellular; Microvessels invasion

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The overall survival is defined as the percentage of patients who are alive at 5 years after their enrollments of this study.

  5 years

Secondary Outcomes (2)

• Disease-free survival

  5 years

• Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  5 years

Study Arms (2)

Adjuvant TACE

EXPERIMENTAL

Adjuvant TACE were performed 4-6 weeks after surgery

Procedure: Adjuvant TACE

Follow-up

OTHER

Routine follow-up were performed instead of adjuvant TACE

Procedure: Follow-up

Interventions

Adjuvant TACE PROCEDURE

1\~2 cycles TACE were performed as adjuvant therapy after radical hepatectomy

Adjuvant TACE

Follow-up PROCEDURE

Patients received just follow-up to monitor the recurrence of HCC

Follow-up

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~75 years;
• Eastern Cooperative Oncology Group performance status (ECOG PS) score \<=2;
• Histologically confirmed hepatocellular carcinoma with microvessels invasion;
• No previous treatment for HCC;
• More than 5 cm solitary tumor before surgery confirmed by more than 2 radiological examinations;
• R0 resection achieved;
• No recurrence evidence in radiological follow-up 3\~7 weeks after surgery;
• Adequate hematologic parameters and liver and kidney functions: (1) Neutrophils Absolute \>=1.5\*10\^9/L; (2) Hemoglobin \>=90g/L; (3) Platelet count \>=75\*10\^9/L; (4) Serum albumin \>=35g/L; (5) Serum total bilirubin \<=1.5\* upper limit of normal (ULN); (6) Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \<2.5\*ULN; (7) Serum creatinine \<=1.5\*ULN; (8) International normalized ratio (INR) \<=1.5;
• Give signed informed consent before enrollment.

You may not qualify if:

• Function impairment of vital organs (heart, lung, kidney, etc), serious infection or \>grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0);
• Histologically confirmed of positive resection margin (R1 resection);
• Previous or current malignant tumor beyond HCC;
• Allergy to any agent of the TACE regimen;
• History of organ transplantation;
• Previously receiving other treatments for HCC;
• Pregnant or breastfeeding women, and women of childbearing potential without adequate contraception;
• Neurological or mental abnormalities that may affect cognitive assessment and inform consent;
• Concomitant anti-tumor therapy or participating in other interventional clinical trials;
• Other psychological, family or social reason, which would affect compliance with the study protocol.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (4)

• 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.

  PMID: 19408012 BACKGROUND

• Li JQ, Zhang YQ, Zhang WZ. [Evaluation of chemoembolization as an adjuvant therapy for primary liver carcinoma after surgical resection]. Zhonghua Zhong Liu Za Zhi. 1994 Sep;16(5):387-9. Chinese.

  PMID: 7895595 BACKGROUND

• Li JQ, Zhang YQ, Zhang WZ, Yuan YF, Li GH. Randomized study of chemoembolization as an adjuvant therapy for primary liver carcinoma after hepatectomy. J Cancer Res Clin Oncol. 1995;121(6):364-6. doi: 10.1007/BF01225689.

  PMID: 7541051 BACKGROUND

• Peng B, Liang L, He Q, Zhou F, Luo S. Surgical treatment for hepatocellular carcinoma with portal vein tumor thrombus. Hepatogastroenterology. 2006 May-Jun;53(69):415-9.

  PMID: 16795984 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Rong-ping GUO, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: June 2, 2016
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2015
• Last Updated: June 20, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)