Comparison of Efficacy in SBRT of Large HCC With or Without TACE

Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Large Hepatocellular Carcinoma (5-10 cm) With or Without Transcatheter Arterial Chemoembolization (TACE)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04512846

Enrollment

100

Registered

2020-08-14

Start date

2020-08-01

Completion date

2026-08-30

Last updated

2023-06-27

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

Conditions

Large HCC Patients, Stereotactic Body Radiation Therapy, Transcatheter Arterial Chemoembolization

Keywords

CyberKnife, SBRT, large HCC, prognosis

Brief summary

The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

* primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology * single lesion and longest tumor diameter were 5-10cm; * CP-A or B classification; * Eastern Cooperative Oncology Group (ECOG) score 0-1; * distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm * unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc. * rejecting other therapies such as resection, liver transplantation, etc. * platelet count≥50 × 109/L, white blood count≥1.5 × 109/L; * 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

* tumor thrombus; * lymph node involvement; * extrahepatic metastasis.

Design outcomes

Primary

Measure	Time frame	Description
Overall survival time	From date of randomization until the date of death from any cause, assessed up to 36 months	OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.
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 36 months	PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.
Local control time	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.

Secondary

Measure	Time frame
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.

Countries

China

Contacts

Primary ContactJing Sun

519299998@qq.com+8613718681094

Backup ContactXuezhang Duan

duanxuezhang2006@163.com+8613621386161

Outcome results