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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05057104

Enrollment

320

Registered

2021-09-27

Start date

2021-10-10

Completion date

2024-12-31

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conversion, Hepatocellular Carcinoma Non-resectable

Keywords

CyberKnife, unresectable hepatocelluar carcinoma, TACE, hepatectomy, prognosis

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Contacts

Primary ContactXuezhang Duan

duanxuezhang2006@163.com+8613621386161

Backup ContactJing Sun

519299998@qq.com+8613718681094

Outcome results