Hepatocellular Carcinoma
Conditions
Interventions
Treatment Group:SBRT+AK112
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Diagnosed with hepatocellular carcinoma by histological/cytological examination or meeting the clinical diagnostic criteria for hepatocellular carcinoma. (2)Patients with advanced liver cancer who have predominantly intrahepatic progression (Intrahepatic Progression) following the failure of first-line standard targeted and immunotherapy, with no progression or stable condition of other lesions. (3)Intrahepatic lesions =3 and located more than 1 cm from hollow organs such as the gastrointestinal tract, with no extrahepatic lesions requiring immediate palliative treatment. (4)Normal liver volume >700 ml. (5)Child-Pugh class A liver function, with the following laboratory parameters: Neutrophils =1.5×10^9/L Platelets =75×10^9/L Hemoglobin =90 g/L (no transfusion or erythropoiesis-stimulating agent dependency within the past 2 weeks) Serum creatinine =1.5 times ULN or calculated creatinine clearance =60 ml/min (Cockcroft-Gault formula) AST =2.5 times ULN, ALT =2.5 times ULN; if intrahepatic lesions are present, ALT and AST =5 times ULN Coagulation function: International Normalized Ratio (INR) =2 times ULN and activated partial thromboplastin time (APTT) =1.5 times ULN (6)ECOG performance status score of 0-1. (7)Expected survival time >3 months. (8)No history of radiotherapy. (9)Age between 18 and 75 years. (10)Signed informed consent and ability to comply with the protocol-specified visits and procedures. (11)Women of childbearing potential or men with partners of childbearing potential must use effective contraception during the study period and for 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: (1)Histologically containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components. (2)History of hepatic encephalopathy or liver transplantation. (3)Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage. Patients with small amounts of pleural effusion, ascites, or pericardial effusion detected only by imaging and without symptoms can be included. (4)Acute or chronic active hepatitis B or hepatitis C infection, with hepatitis B virus (HBV) DNA >2000 IU/ml or 10^4 copies/ml; hepatitis C virus (HCV) RNA >10^3 copies/ml; positive for both hepatitis B surface antigen (HbsAg) and anti-HCV antibodies. (5)Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases or brain metastases with stable symptoms after treatment can participate in this study if they meet all of the following criteria: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, medulla, or spinal cord metastases; clinically stable for at least 4 weeks; and discontinued glucocorticoid therapy for at least 2 weeks before the first dose of the study drug. (6)History of gastrointestinal perforation and/or fistula within the past 6 months, history of bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), inflammatory bowel disease, extensive bowel resection (partial colectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. (7)History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia, or active pneumonia. (8)Active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year before the first dose. (9)Active or poorly controlled severe infection; poorly controlled diabetes; coagulation disorders, bleeding tendencies, or currently receiving thrombolytic or anticoagulant therapy. (10)Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). (11)Active autoimmune disease requiring systemic treatment or history of such a disease within the past 2 years. Known history of primary immunodeficiency. (12)Use of immunosuppressive drugs within the past 4 weeks, excluding nasal, inhaled, or other local glucocorticoids or systemic glucocorticoids at physiological doses (i.e., not exceeding 10 mg/day of prednisone or equivalent doses of other glucocorticoids). Temporary use of glucocorticoids for the treatment of dyspnea due to diseases such as asthma and chronic obstructive pulmonary disease is allowed. (13)Confirmed history of congestive heart failure; poorly controlled angina pectoris; electrocardiographically confirmed transmural myocardial infarction; poorly controlled hypertension; clinically significant valvular heart disease; or high-risk, uncontrolled arrhythmias. (14)Known allergy to any study drug. (15)Major surgery (craniotomy, thoracotomy, or laparotomy) within the past 4 weeks or unhealed wounds, ulcers, or fractures. (16)Diagnosis of other malignancies within the 5 years before the first dose, excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or in situ cancer that has been radically resected. If diagnosed with other malignancies or liver cancer more than 5 years before the first dose, pathological or cytological diagnosis of recurrent metastatic lesions is r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control rate, LCR;Overall survival, OS;objective response rate, ORR;disease control rate, DCR;adverse event, AE; | — |
Countries
China
Contacts
Public ContactYixing Chen
Zhongshan Hospital, Fudan University
Outcome results
None listed