hepatocellular carcinoma complicated with portal vein tumor thrombus
Conditions
Interventions
Experimental group:Radiotherapy combined with Atezolizumab plus Bevacizumab
Sponsors
The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Men or non-pregnant women aged 18 to 70 years; 2. Sign the informed consent; 3. The investigator believes that the patient has the ability to comply with the research protocol; 4. Hepatocellular carcinoma (HCC) is diagnosed by histology or cytology or clinically. Patients with liver cirrhosis are clinically diagnosed by AASLD criteria, and patients without liver cirrhosis need to be diagnosed by histology; 5. Imaging examination confirmed the existence of portal vein tumor thrombus; 6. The disease is not suitable for radical surgery; 7. Have not received any anti-tumor therapy before; 8. At least 1 measurable (measurable according to RECIST1.1), untreated lesions; 9. Pre-treatment tumor tissue samples (if available). If tumor tissue is available, submit 1 formalin-fixed, paraffin-embedded (FFPE) tumor sample in a paraffin block (preferred), or approximately 10-15 slides containing unstained, freshly cut, serial sections radiographs, together with a relevant pathology report within 4 weeks of enrollment. If the FFPE samples described above are not available, any type of sample (including fine needle aspiration biopsy samples, cell mass samples [eg, from pleural effusions], and lavage samples) is acceptable. A relevant pathology report should be provided with the sample. If tumor tissue was not available (eg, exhausted due to previous diagnostic testing), the patient was still eligible to participate in the study. 10. ECOG performance status score of 0 or 1 within 7 days before enrollment; 11. Child-Pugh Grade A within 7 days before enrollment; 12. Adequate hematology and organ function, based on the following laboratory test results obtained within 7 days prior to enrollment (unless otherwise stated): (1) Absolute neutrophil count (ANC)>=1.5x10^9/L (1500/µL), without granulocyte colony-stimulating factor support; (2) Lymphocyte count >=0.5x10^9/L (500/µL); (3) Platelet count >= 75x10^9/L (75,000/µL), no blood transfusion; hemoglobin >= 90 g/L (9 g/dL), in order to meet this criterion, blood transfusion is allowed to the patient; (4) AST, ALT and alkaline phosphatase (ALP) = 50 mL/min (calculated using the Cockcroft-Gault formula); (7) Serum albumin>=28 g/L (2.8 g/dL); (8) Patients not receiving anticoagulation therapy: INR or aPTT =2+ proteinuria should collect 24-hour urine, and then must confirm that the urine protein content within 24 hours is less than 1 g. 13. Any acute, clinically significant treatment-related toxicity (due to previous treatment) must have been alleviated to <= grade 1 before enrolling in the study, except for alopecia; 14. HIV antibody test results are negative at the time of screening; 15. Patients with active hepatitis B virus (HBV) infection: HBVDNA <500IU/mL obtained within 28 days before the start of study treatment, and received anti-HBV treatment for at least 14 days before entering the study (treatment according to local standard treatment, such as entecavir) and are willing to continue receiving treatment during the study; 16. Women of childb
Exclusion criteria
Exclusion criteria: 1. History of leptomeningitis; 2. Current or past autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sj?gren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: patients with prior autoimmune-related hypothyroidism receiving thyroid hormone replacement therapy are eligible for study participation; patients receiving insulin therapy Patients with controlled type 1 diabetes were eligible for study participation; only patients with dermatologically manifested eczema, psoriasis, chronic lichen simplex, or vitiligo (eg, excluding patients with psoriatic arthritis), provided All of the following conditions are eligible to participate in the study: (1) The rash area must be less than 10% of the body surface area; (2) Good disease control at baseline, requiring only low-efficiency topical glucocorticoid therapy; (3) In the past 12 months, the pre-existing conditions did not require psoralen plus A-band UV radiation, methotrexate, vitamin A acid, biological agents, oral calcineurin inhibitors, or highly effective or Acute exacerbations of oral glucocorticoid therapy. 3. Idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia or evidence of active pneumonia on chest computed tomography (CT) images during screening. Radiation pneumonitis in the permissible radiation zone (fibrosis); 4. Known active tuberculosis; 5. Major cardiovascular disease within 3 months prior to initiation of study treatment (such as New York Heart Association class II or more severe heart disease, myocardial infarction or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable Arrhythmia or unstable angina; 6. History of congenital long QT syndrome or corrected QT interval at screening >500ms (calculated using Fridericia method); 7. History of uncorrectable serum potassium, calcium or magnesium electrolyte disturbances; 8. Received major surgery (except for diagnosis) within 4 weeks before starting the study treatment or is expected to undergo major surgery during the study period; 9. Malignant tumors other than HCC within 5 years prior to screening, except for malignancies with negligible risk of metastasis or death (eg, 5-year OS rate >90%), such as adequately treated in situ cervical cancer, Non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 10. Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; 11. Oral or intravenous therapeutic antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (eg, to prevent urinary tract infections or exacerbations of chronic obstructive pulmonary disease) are eligible to participate in the study. 12. Previous allogeneic stem cell or solid organ transplantation; 13. Received a live attenuated vaccine within 4 weeks before starting study treatment, or is expected to receive such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab; 14. Patients with untreated or incompletely treated esophageal a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Progression-free survival;Time to progression;Duration of response;Conversion rate of surgical resection; | — |
Countries
China
Contacts
Public ContactWang Kang
The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army
Outcome results
None listed