Hepatobiliary and pancreatic malignancies
Conditions
Interventions
experimental group:Sequential cariolizumab treatment after stereotactic radiation therapy or ablation
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Hepatocellular carcinoma (HCC) based on histopathological or cytological findings or a previous diagnosis of cirrhosis with typical imaging features; 3. Patients with inoperable or transplantable liver cancer including intrahepatic metastases were enrolled, and there were no extrahepatic metastases. Previous local treatments with radiographically confirmed progression following these local treatments were allowed. The lesion is no more than 5cm in diameter or the number of lesions is 2-3, the largest diameter of a single tumor is less than or equal to 3cm, and SBRT or ablation can be performed; 4. Laboratory test results must meet the following criteria: neutrophils >= 1.5 x 10^9/L; platelets >= 75 x 10^9/L; hemoglobin >= 90g/L (no blood transfusion in the past 14 days); serum Cr 60 ml/min (Cockcroft-Gault formula); AST = 6 months; 7. No history of abdominal radiotherapy; 8. The patient can understand and is willing to sign the written informed consent document; 9. Female patients of childbearing age or male patients whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Fibrous hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma; 2. History of hepatic encephalopathy or liver transplantation; 3. Untreated hepatitis infection: HBV DNA > 2000IU/ml or 104 copies/ml, HCV RNA > 103 copies/ml, positive for HbsAg and anti-HCV antibodies; 4. Patients should not receive corticosteroid therapy, or only receive a stable dose of <=10 mg prednisone/day (or equivalent dose of other corticosteroids); 5. Have a history of inflammatory bowel disease, Crohn's disease, ulcerative colitis or chronic diarrhea; 6. Symptomatic interstitial lung disease; 7. Evidence of active tuberculosis (TB). Patients diagnosed with active TB infection within 1 year should be excluded even if they have been treated; 8. Immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) positive patients; 9. Serious infection is active or under clinical control; 10. Patients with known or suspected autoimmune diseases; 11. Has been using immunosuppressive drugs for the past four weeks, excluding topical corticosteroids by nasal spray, inhalation, or other routes, or application of systemic corticosteroids (ie, prednisone or equivalent doses of other corticosteroids, daily not more than 10 mg), and the temporary use of corticosteroids to treat dyspnea symptoms of asthma; 11. Any anti-infection vaccines (such as flu vaccine, chickenpox vaccine, etc.) within the past 4 weeks; 12. Received systemic immunostimulatory therapy in the past four weeks; 13. Major surgery (craniotomy, thoracotomy, or laparotomy) or unhealed wound, ulcer, or fracture in the past four weeks. 14. Previous immune checkpoint inhibition therapy with anti-PD-1/PD-L1/PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell costimulation or checkpoint pathways) 15. Pregnant or lactating women; 16. Those with serious medical or psychiatric diseases who cannot be treated as prescribed by a doctor; 17. Patients who have participated in clinical trials of other drugs within four weeks. 16. who have a serious medical or psychiatric condition that prevents them from following medical advice 17. patients who have participated in a clinical trial of another drug within four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Objective mitigation rate;Overall survival;Adverse Events Occurrence; | — |
Countries
China
Contacts
Public ContactXu Ximing
Renmin Hospital of Wuhan University
Outcome results
None listed