HCC
Conditions
Interventions
Experimental group:hypofractionated radiotherapy combined with immunotherapy
Sponsors
The First Affiliated Hospital of Henan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed as hepatocellular carcinoma by clinical or histopathological examination in accordance with the 2024 edition of the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer; 2. Aged 18-80 years; 3. In good general condition, with an ECOG score of 0-1; 4. Relatively insufficient remaining liver volume or relatively poor liver function. After estimating that the target area includes portal vein tumor thrombus/hepatic vein tumor thrombus and the connected primary main lesions, the estimated volume of Liver-GTV receiving 150ml and =80g/L, ANC >=1.0*10?/L, PLT >=40*10?/L; 14. Coagulation function: no bleeding tendency; 15. Patients voluntarily participate in this clinical trial and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Currently participating in other drug clinical trials; 2. Having received previous abdominal radiotherapy or having undergone liver transplantation; 3. Having severe chronic diseases of important organs such as the heart and kidneys; 4. Suspected or confirmed drug addicts, drug abusers, or alcoholics; 5. Likely to be allergic to sorafenib or toripalimab treatment; 6. Patients who have previously received anti-PD-1, anti-PD-L1 drugs, or drugs acting on another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, OX-40, or CD137); 7. Having severe mental or neurological disorders that affect informed consent and/or the expression or observation of adverse reactions; 8. Having been clinically diagnosed with hepatic encephalopathy in the past 6 months. Subjects with hepatic encephalopathy controlled by rifaximin or lactulose are not allowed to participate in the study; 9. Having moderate to severe ascites with obvious symptoms (ascites reaching a Child-Pugh score of 3 points); 10. Having had a secondary malignant tumor or other tumors (except superficial skin cancer, localized low-grade malignant tumors, and carcinoma in situ) within 3 years before the start of the study; 11. Having a history of gastrointestinal bleeding within 6 months before enrollment, or being at high risk of esophageal and gastric variceal bleeding as diagnosed by ERCP/CT/DSA; 12. Having severe unhealed wounds, ulcers, or fractures; 13. Having active central nervous system metastasis or carcinomatous meningitis; 14. Having active tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year before the first dose; 15. Having a history of biliary fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before enrollment; 16. Having unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, congestive heart failure, or cerebrovascular accident (including transient ischemic attack, pulmonary embolism) within 3 months before enrollment; 17. Having persistent arrhythmia (CTCAE grade 2 or above), atrial fibrillation of any degree, or prolonged QTc interval (more than 450 milliseconds in men and more than 470 milliseconds in women); 18. Having refractory hypertension (blood pressure remains higher than 150/100 mmHg after optimal drug treatment); 19. Having a known history of human immunodeficiency virus (HIV) infection; 20. Pregnant or lactating women; 21. Having received a live vaccine within 30 days before the first administration of the study drug. Live vaccines include but are not limited to: measles, mumps, chickenpox/herpes zoster (varicella), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines for injection are usually inactivated virus vaccines and are therefore allowed; however, intranasal influenza vaccines (e.g., X-40 or FluMist) are live attenuated vaccines and are not allowed; 22. Having active autoimmune diseases requiring systemic treatment within the past 2 years (autoimmune diseases such as autoimmune hepatitis, interstitial pneumonia, uveitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis, hyperthyroidism or hypothyroidism, asthma requiring treatment with bronchodilator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS;objective response rate, ORR;safety; | — |
Countries
China
Contacts
Public ContactKang Xiaohong
The First Affiliated Hospital of Henan Medical University
Outcome results
None listed