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Clinical Trials/NCT03116984
NCT03116984
Unknown
Phase 3

A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for HCC Which is Unresectable But Confined to the Liver

Shanghai Zhongshan Hospital1 site in 1 country300 target enrollmentJanuary 1, 2017

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hepatocellular Carcinoma
Sponsor
Shanghai Zhongshan Hospital
Enrollment
300
Locations
1
Primary Endpoint
3-year overall survival(OS)
Last Updated
6 years ago

Overview

Brief 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.

Detailed Description

Enrolled HCC patients met the inclusion criterion, in the late or advanced stage,tumor confined in intrahepatic( meet the tolerance-dose for the liver), without cancer embolus in main branch of portal vein, without extrahepatic metastasis and the number of tumor was≤3. Eligible participants will be randomly assigned to the group A by TACE and the other group B by EBRT after 2 times TACE. TACE group: The frequency of treatment is determined based on the disease condition for patients who are randomly assigned to group of TACE.TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery, and micro-embolization superselective catheterization is preferred.Adriamycin(30 to 60mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion.The dose of fluid lipiodol was determined by diameter and blood supply type of HCC,generally 5-20ml, and no more than 30ml once.The boundary is considered whether there are large amounts of lipiodol to deposit in the tumor and tiny branches shadow of portal veins in paracarcinoma under fluoroscopic guidance. Embolizing agents(gelatin sponge particles 350um-560um) are added after lipiodol emulsion embolization.It has a possibility of observeation alone if tumor achieves a complete response after two times TACE. EBRT group: Patients who were randomized to the radiotherapy group start radiotherapy 3-5 weeks after the completion 2 times TACE and began to undergo radiation. Radiotherapy equipment is based on the conditions of the cooperative units. 3-dimensional conformal radiation therapy(3-DCRT), intensity-modulated radiation therapy(IMRT) or Image-Guided Radiotherapy(IGRT) will be opted based on hospital. IGRT can also be used via helical tomotherapy, Rapid Arc or Volumetric Modulated Arc Therapy(VMAT). The target volume should include the visible tumor.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Zeng Zhaochong

Director, Head of Department of Radiation Oncology, Principal Investigator, Clinical Professor

Shanghai Zhongshan Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

3-year overall survival(OS)

Time Frame: The outcome measures are assessed up to three years.

The therapeutic effects are mainly evaluated by the 3-year overall survival(OS).

Study Sites (1)

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