Hepatocellular carcinoma
Conditions
Interventions
Trial Group:Stereotactic body radiation therapy (SBRT): Robotic X-ray (CyberKnife), 7Gy per session per day, 5 sessions per week, completed within one week
radiation intensity (low/medium/high) adjusted based on target volume and liver function. Systemic therapy: anti-PD1 monoclonal antibody (dose adjusted based on weight and biomarkers) combined with be
Sponsors
Thrid Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.age >= 18 and <= 70years, ECOG Performance Status 0 -1; 2.pathologically or clinically diagnosed as HCC; 3.Locally advanced HCC (CNLC Stage IIIa): Portal vein tumor thrombus (PVTT) extent categorized as Type IIIa or higher according to "Cheng's" classification (involving the main portal vein trunk =2 cm), including hepatic vein and inferior vena cava tumor thrombus. The case must be assessed by three senior attending hepatobiliary surgeons as initially unresectable or potentially resectable. 4.Child-Pugh grade A or B7; 5.Baseline laboratory tests meet the following conditions: hemoglobin =90g/L, absolute neutrophil count =2.5×10^9/L, platelet count =75×10^9/L; ALT or AST = 3 times the upper limit of normal, alkaline phosphatase = 2.5 times the upper limit of normal, ALB =30g/L;Plasma creatinine less than 1.5 times the upper limit of normal; Plasma prothrombin time is normal or exceeds the upper limit of normal value by = 4 seconds; 6.voluntarily sign the informed consent;
Exclusion criteria
Exclusion criteria: 1. Child-Pugh grade above B7; 2. Previous allergic reactions to drugs in the same class or radiation therapy; 3. Occurrence of or currently suffering from other malignancies within the past 5 years; 4. Patients with a history of interstitial lung disease, severe cardiovascular disorders, or uncontrolled systemic diseases, including but not limited to diabetes, hypertension, pulmonary fibrosis, or acute pulmonary conditions; 5. presence of any active immunodeficiency or autoimmune disease at screening, and/or a history of any immunodeficiency or autoimmune disease with a potential risk of recurrence; 6. history of allogeneic organ transplantation; 7. any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Major pathologic response;Objective overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response;Conversion rate;Recurrence free survival;Overall survival;Dynamic changes in peripheral blood immune cells, IL-6-related cytokines, and circulating tumor cells (CTCs); | — |
Countries
China
Contacts
Public ContactLi Yong
Thrid Affiliated Hospital of Naval Medical University
Outcome results
None listed