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

Beijing 302 Hospital

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma Non-resectable; Conversion

Study type: Observational

Funder types: Other

Identifiers

NCT05057104

SBRTplusTACE VS. HR

Details and patient eligibility

About

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

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Exclusion criteria

-the patients receive other treatments (such as targeted treatment, immune checkpoint inhibitors,etc) after CK-SBRT plus TACE.

Trial design

320 participants in 2 patient groups

CK-SBRT with TACE group

Conversion hepatectomy after CK-SBRT plus TACE