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

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: External- beam radiotherapy; Procedure: Transcatheter arterial chemoembolization

• Registration Number: NCT03116984
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-17
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External-beam radiotherapy	External- beam radiotherapy	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.
Transcatheter arterial chemoembolization	Transcatheter arterial chemoembolization	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.

Primary Outcome Measures

Name	Time	Method
3-year overall survival(OS)	The outcome measures are assessed up to three years.	The therapeutic effects are mainly evaluated by the 3-year overall survival(OS).

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China