This study is a single arm, single center, open label clinical trial. Recruit 34 subjects who meet the inclusion criteria and receive hepatic artery chemoembolization (TACE) and stereotactic body radiotherapy (SBRT) combined with immune checkpoint inhibitors and donafenib treatment according to the study plan. The treatment cycle and dosage can be adjusted according to the patient's tolerance. Until disease progression or intolerable toxic reactions occur. Observe the effectiveness and safety indicators during the experimental process.
Age range from 18 to 75 years old (including 18 and 75), with no gender restrictions;
Hepatocellular carcinoma diagnosed by histopathology, cytology or imaging;
Has not received any systemic anti-tumor therapy for the current stage of the disease in the past, including surgery (excluding stent placement), radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy;
CNLC staging Ib IIIa stage, cannot be surgically removed;
Known patients who are allergic to the components of the investigational drug;
Patients known to have central nervous system metastases;
Severe gastrointestinal dysfunction (with bleeding, severe inflammation, obstruction, or diarrhea greater than grade 2);
Serious infections (CTC AE>grade 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and infection complications that require hospitalization. Symptoms and signs of infection within the first 2 weeks of enrollment require intravenous antibiotic treatment (excluding prophylactic use of antibiotics);
Single group
Donafina
DrugDuring the treatment, oral administration of Donafenib (0.2g, bid) was consistently administered
PD-1/PD-L1 inhibitor
DrugAccording to the specific drug instructions, Q3W， The maximum usage time is 2 years
Objective Response Rate, ORR
Overall survival, OS
disease control rate
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This trial is not recruiting at the moment. You can still explore other options:
