Small Hepatocellular Carcinoma, Stereotactic Body Radiation Therapy, Transcatheter Arterial Chemoembolization
Conditions
Keywords
CyberKnife, SBRT, TACE, prognosis
Brief summary
The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) 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
PROCEDUREtranscatheter arterial chemoembolization
The hepatocellular carcinoma patients (≤5cm）who received SBRT are devided into two groups: with TACE and SBRT alone.
Sponsors
Beijing 302 Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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 ≤ 5.0 cm * 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 rates | 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 rates | 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 rates | 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, Master
Backup ContactXuezhang Duan, PH.D
Outcome results
None listed