hepatocellular carcinoma
Conditions
Interventions
control group :atezolizumab and bevacizumab
experimental group :radiotherapy combined with atezolizumab and bevacizumab
Sponsors
The Third Affiliated Hospital of the Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients meeting all of the following inclusion criteria will be eligible for enrollment in this study: 1. Male or non-pregnant female aged 18 to 70 years. 2. Signed informed consent form. 3. Determined by the investigator to be able to comply with the study protocol. 4. Histologically or cytologically diagnosed with hepatocellular carcinoma (HCC), with clinical diagnosis of cirrhosis made according to the AASLD criteria; non-cirrhotic patients require histological confirmation. 5. Imaging confirms the presence of portal vein tumor thrombosis. 6. Disease not suitable for curative surgery. 7. No prior antitumor therapy. 8. At least 1 measurable (per RECIST 1.1) lesion not previously treated. 9. Available pre-treatment tumor tissue sample (if obtainable). If tumor tissue is obtainable, either 1 formalin-fixed, paraffin-embedded (FFPE) tumor sample block (preferred) or approximately 10-15 unstained freshly cut consecutive slides with accompanying pathology report, along with a pathology report from a relevant biopsy within 4 weeks before randomization. If FFPE tissue is unavailable, any type of sample (including fine-needle aspirates, core biopsies [e.g., from pleural effusion], and lavage samples) is acceptable. A relevant pathology report must be provided with the sample. If tumor tissue is unavailable (e.g., exhausted by previous diagnostic testing), the patient is still eligible for the study. 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization. 11. Child-Pugh class A within 7 days before randomization. 12. Adequate hematologic and organ function, as determined by the following laboratory results obtained within 7 days before randomization (unless otherwise indicated): absolute neutrophil count (ANC) =1.5 × 10^9/L (1500/µL), without granulocyte-colony stimulating factor support; lymphocyte count =0.5 × 10^9/L (500/µL); platelet count =75 × 10^9/L (75,000/µL), without transfusion; hemoglobin =90 g/L (9 g/dL); for patients receiving blood transfusions to meet this criterion, serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =5 × ULN; serum bilirubin =3 × ULN; serum creatinine =1.5 × ULN or calculated creatinine clearance =50 mL/min (using the Cockcroft-Gault formula); serum albumin =28 g/L (2.8 g/dL); for patients not receiving anticoagulation therapy, international normalized ratio (INR) or activated partial thromboplastin time (aPTT) =2 × ULN; dipstick urinalysis result 1 that was due to the prior treatment and that had not resolved to grade =1, excluding alopecia, within 7 days before randomization. 14. Negative HIV antibody test result at screening. 15. Patients with active hepatitis B virus (HBV) infection: HBV DNA <500 IU/mL within 28 days before randomization, have received at least 14 days of antiviral therapy before randomization (as per local standards, e.g., entecavir), and are willing to continue antiviral therapy during the study. 16. Women of childbearing potential must have a negative pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) within 7 days before randomization; women of childbearing potential and men (who engage in sexual activity with women of ch
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will not be eligible for enrollment in this study: 1. History of aseptic meningitis. 2. Current or prior autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis. Exceptions include patients with prior autoimmune-related hypothyroidism who are receiving thyroid hormone replacement therapy, or controlled type 1 diabetes patients on insulin therapy. Eligibility is possible for patients solely manifesting dermatological clinical features of eczema, psoriasis, chronic simple lichen, or vitiligo, provided they meet all the following conditions: (1) skin rash covers 500 milliseconds on screening using Fridericia's correction. 7. Unmanageable history of electrolyte disturbances such as serum potassium, calcium, or magnesium imbalances. 8. Underwent major surgery within 4 weeks before randomization (excluding diagnostic procedures) or is anticipated to require major surgery during the study period. 9. Experienced malignancies other than hepatocellular carcinoma (HCC) within 5 years before randomization, except for negligible-risk malignancies (e.g., 5-year overall survival >90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. 10. Severe infection within 4 weeks before randomization, including but not limited to hospitalization due to infection, sepsis, or severe pneumonia. 11. Oral or intravenous treatment with therapeutic antibiotics within 2 weeks before randomization. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible. 12. Prior allogeneic hematopoietic stem cell or solid organ transplantation. 13. Received attenuated live vaccines within 4 weeks before randomization, or is expected to receive such vaccines during the study period or within 5 months following the last dose of atezolizumab. 14. Untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk of bleeding. Patients must have undergone ultrasound, CT, magnetic resonance imaging, or liver stiffness assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Disease control rate;Duration of response;Time to progression;Conversion rate of surgical resection; Assessment of Quality of Life; | — |
Countries
China
Contacts
Public ContactCheng Shuqun
The Third Affiliated Hospital of the Naval Medical University
Outcome results
None listed