Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy

Sponsor

Beijing 302 Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05057104

Collaborator

(none)

320

Enrollment

38.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Non-resectable Conversion

Study Design

Study Type:

Observational

Anticipated Enrollment :

320 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy

Anticipated Study Start Date :

Oct 10, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
CK-SBRT with TACE group
Conversion hepatectomy after CK-SBRT plus TACE

Outcome Measures

Primary Outcome Measures

Overall survival time [From date of randomization until the date of death from any cause, assessed up to 24 months.]

Secondary Outcome Measures

Progression-free survival time [From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 24 months.]
Radiation-induced liver injury rates [From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.]
Adverse reaction [From the date of radiotherapy completion until the 4 months after therapy,up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Unresectable HCC patients were diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
Patients who received SBRT plus TACE have tumor regression, and surgical experts assess that R0 resection could be achieved
CP-A or B classification;
Eastern Cooperative Oncology Group (ECOG) score 0-1;
Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
ICG R15≤10%;
Normal effective liver volume >30%;
patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.