A Study of Comparison of TACE Combination With and Without EBRT for Advanced HCC

Summary

This clinical trial is a prospective, randomized, controlled and multicenter study.And the trial is going to better control intrahepatic tumors for hepatocellular carcinoma(HCC) patients who meet the inclusion criterion.The patients were divided into two groups, the group A by TACE and the other group B by external- beam radiotherapy(EBRT) after 2 times TACE. Then the therapeutic effects and toxicities of TACE and EBRT are evaluated during the follow-up period. The study design plans to enroll 300 patients, and each group includes 150 cases.

Conditions

• Hepatocellular Carcinoma

Interventions

PROCEDURE

Transcatheter arterial chemoembolization

Transcatheter arterial chemoembolization (TACE) is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol was determined by diameter and blood supply type of HCC, generally 5-20ml, and no more than 30ml once.

RADIATION

External- beam radiotherapy

We have reported a series of retrospective clinical trials in which transarterial chemoembolization (TACE) combined with external- beam radiotherapy (EBRT) was a better treatment method than TACE alone for unresectable HCC in the same period and organization, no matter in aspects of the regression rate of carcinoma or survival.Patients who were randomized to the EBRT 3-5 weeks after the completion 2 times TACE.

Sponsors & Collaborators

• Changhai Hospital

  collaborator OTHER

• Shanghai 10th People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Zhongshan Hospital Xiamen University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• 309th Hospital of Chinese People's Liberation Army

  collaborator OTHER

• Heilongjiang Provincial Agricultural Reclamation General Hospital

  collaborator UNKNOWN

• Longyan First Hospital, Affiliated to Fujian Medical University

  collaborator UNKNOWN

• Peking University First Hospital

  collaborator OTHER

• The Third Affiliated Hospital of Qiqihar Medical Universitiy

  collaborator UNKNOWN

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Qingdao University

  collaborator OTHER

• The 4th people's hospital of Wuxi City, Affiliated to Jiangnan University

  collaborator UNKNOWN

• Subei People's Hospital of Jiangsu Province,Yangzhou University

  collaborator UNKNOWN

• Affiliated Zhongshan Hospital of Dalian University

  collaborator OTHER

• Jilin University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Shanghai East Hospital,Tongji University School of Medicine

  collaborator UNKNOWN

• Chinese PLA General Hospital

  collaborator OTHER

• The 4th People's Hospital of Linfen City

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Yunnan Cancer Hospital

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• The People's Hospital of Hunan Province

  collaborator UNKNOWN

• Shanghai Zhongshan Hospital

  lead OTHER

Principal Investigators

• Zhongshan Hospital · Fudan University, Shanghai, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-01

Primary Completion

2020-12-30

Completion

2020-12-31

Countries

• China

Study Locations