NCT03116984

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

March 1, 2017

Last Update Submit

April 8, 2020

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinomaexternal- beam radiotherapy (EBRT)transarterial chemoembolization (TACE)

Outcome Measures

Primary Outcomes (1)

  • 3-year overall survival(OS)

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

    The outcome measures are assessed up to three years.

Study Arms (2)

Transcatheter arterial chemoembolization

ACTIVE COMPARATOR

TACE group: The frequency of treatment is determined based on the disease condition for patients who are randomly assigned to group of TACE treatment.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 ultra 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.

Procedure: Transcatheter arterial chemoembolization

External-beam radiotherapy

EXPERIMENTAL

EBRT group: Patients who were randomized to the external- beam radiotherapy (EBRT) 3-5 weeks after the completion 2 times TACE.Radiotherapy equipment is based on the conditions of the cooperative units. 3-DCRT, IMRT or IGRT will be opted based on hospital. IGRT can also be used via helical tomotherapy, Rapid Arc or VMAT. The target volume should include the visible tumor.

Radiation: External- beam radiotherapy

Interventions

Transcatheter arterial chemoembolizationPROCEDURE

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.

Also known as: TACE
Transcatheter arterial chemoembolization
External- beam radiotherapyRADIATION

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.

Also known as: EBRT
External-beam radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Halfway exit criteria 1）Do not treat according to the research or seriously violate the fundamental principles after enrolled, 2）Cannot tolerate radiation therapy, including the ones that cann't complete the radiation treatment( the dose \<40 Gy,biological effective dose \<48 Gy), or interrupt more than 2 weeks during radiotherapy, 3）Unwilling to continue this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Zhongshan Hospital

    Fudan University, Shanghai, China

    STUDY DIRECTOR

Central Study Contacts

Zhaochong Zeng, Phd

CONTACT

13817076800zeng.zhaochong@zs-hospital.sh.cn

Yixing Chen, Phd

CONTACT

13916056575chen.yixing@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Department of Radiation Oncology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 1, 2017

First Posted

April 17, 2017

Study Start

January 1, 2017

Primary Completion

December 30, 2020

Study Completion

December 31, 2020

Last Updated

April 10, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)