Hepatocellular carcinoma (HCC)
Conditions
Interventions
Observation Group ( Stereotactic Body Radiotherapy ):None
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. Aged >=70 years old, regardless of gender; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 4. Diagnosed with primary hepatocellular carcinoma (HCC) by pathological examination or clinical criteria, meeting the definition of small hepatocellular carcinoma; 5. Unsuitable for or refuse surgical resection, local ablation or liver transplantation, including but not limited to advanced age, severe comorbidities (cardiac, pulmonary, renal diseases, etc.), high-risk tumor location, poor liver functional reserve, and patient refusal of invasive treatment; 6. Child-Pugh liver function score <=7 (Class A or B); 7. Planned to receive stereotactic body radiotherapy (SBRT) with curative intent (not palliative); 8. Have at least one measurable lesion assessed per the modified Response Evaluation Criteria in Solid Tumors (mRECIST); 9. Satisfactory function of major organs.
Exclusion criteria
Exclusion criteria: 1.Prior radiotherapy, ablation, surgery or transarterial chemoembolization (TACE) targeting the index lesion; 2.Presence of extrahepatic metastasis or vascular invasion (tumor thrombus in portal vein, hepatic vein or inferior vena cava); 3.Diffuse hepatocellular carcinoma or intrahepatic tumor burden exceeding the up-to-7 criterion; 4.Child-Pugh liver function score >= 8 (advanced Class B or Class C); 5.Any condition that may interfere with study results or endanger subject safety, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from Local Progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS(Progression-Free Survival);Treatment-related adverse event(TRAE);OS(Overall Survival);ORR(Objective Response Rate); | — |
Countries
China
Contacts
Public ContactZhang Yuqin
Southern Medical University Southern Hospital
Outcome results
None listed