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

Not yet recruiting

• Conditions: Hepatocellular Carcinoma Non-resectable; Conversion

• Registration Number: NCT05057104
• Lead Sponsor: Beijing 302 Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-15
• Last Update Submitted: 2021-09-15
• Study First Posted: 2021-09-27
• Last Update Posted: 2021-09-27
• Study Start: 2021-10-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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