Liver cancer
Conditions
Interventions
Immunotherapy group:Immunotherapy + Radiotherapy + Thymosin Alpha 1 Precision Regulation Regimen
Sponsors
Chuzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Patients with hepatocellular carcinoma who have previously experienced progression or intolerance after first-line systemic anti-tumor therapy containing PD-1 immunotherapy, or patients who relapsed within 12 months after the start of neoadjuvant or adjuvant therapy, with a clear pathological diagnosis report or medical history, and with clear measurable lesions (> 1 cm). If accessible, re-biopsy is required to explore hepatocellular carcinoma-related molecular markers; 3. No history of congestive heart failure, unstable angina pectoris, or unstable arrhythmia within the past 6 months; 4. The patient's performance status score is 0-3 according to the Eastern Cooperative Oncology Group (ECOG) scoring method, and the expected survival is = 3 months; 5. No previous severe abnormalities in hematopoietic function, heart, lung, liver, kidney function, or immunodeficiency; 6. One week before enrollment, AST and ALT <= 3.0 times the upper limit of normal; creatinine <= 3.0 times the upper limit of normal; 7. Patients must have the ability to understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Those with a history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix; 3. Those with a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the researcher judges that the clinical severity may hinder the signing of the informed consent form or affect the patient's compliance with drug treatment; 4. Clinically severe heart diseases, such as symptomatic coronary heart disease, congestive heart failure of New York Heart Association (NYHA) Class II or more severe, severe arrhythmias requiring drug intervention, or a history of myocardial infarction in the recent 12 months; 5. Those who have undergone organ transplantation and require immunosuppressive therapy; 6. Known significant active infections, or researchers judge that there are significant blood, kidney, metabolic, gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled concomitant diseases; 7. Those allergic to any component of the study drug; 8. Those with a history of immunodeficiency, including positive HIV test results, suffering from other acquired or congenital immunodeficiency diseases, having a history of organ transplantation, or having other immune-related diseases requiring long-term oral hormone therapy; 9. Those in the period of acute or chronic tuberculosis infection (patients with positive T-spot test and suspicious tuberculosis foci on chest X-ray); 10. Other situations that the researcher deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective relief rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactXiangning Dong
Chuzhou First People's Hospital
Outcome results
None listed