unresectable, non-metastatic hepatocellular carcinoma
Conditions
Interventions
Experimental Group:TACE+AK112
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, both male and female; 2. Patients with histologically or pathologically confirmed hepatocellular carcinoma, or meet the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for hepatocellular carcinoma; 3. Barcelona liver cancer stage (BCLC) stage B or C (no extrahepatic metastases), not suitable for curative treatment; 4. Child-Pugh score=10 mm, and the short diameter of CT scan of lymph node lesions is >=15 mm); 7. Expected survival greater than 12 weeks; 8. The function of vital organs meets the following requirements: blood routine: absolute neutrophil count (ANC) >=1.5×109/L, platelet count (PLT) >=75×109/L, hemoglobin (HGB) >=90g/L; Liver function: serum total bilirubin (TBIL) =28 g/L; After conventional hepatoprotective therapy, it meets the above criteria and can be stable for at least 1 week, and can be enrolled after evaluation by the investigator; Renal function: serum creatinine (Cr) =50 mL/mi (standard Cockcroft-Gault formula applied); Coagulation function: International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) <=2×ULN; 9. Understand and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Fibrolamellar-containing hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by tissue or pathology; 2. Previous local therapy for the target lesion, such as TACE, transarterial embolization (TAE), transarterial radioembolization (TARE), hepatic arterial perfusion chemotherapy (HAIC), radiofrequency ablation, cryoablation, high-intensity focused ultrasound or radiotherapy, etc. Study participants with postoperative prophylactic TACE for curative therapy are allowed to enroll, subject to a washout period of > = 12 weeks; 3. Previous systemic anti-tumor therapy for hepatocellular carcinoma, including molecularly targeted drugs, systemic chemotherapy, immunotherapy (such as immune checkpoint inhibitors, immune checkpoint agonists, immune cells, etc.), biological therapy (such as tumor vaccines, cytokines, growth factors that control cancer, etc.); 4. Presence of Vp3 or Vp4 type portal vein cancer thrombus (Vp3: cancer thrombus involving the left or right branch of the portal vein; VP4: cancer thrombus involving the portal vein trunk or above), presence of hepatic vein or inferior vena cava cancer thrombus; 5. Bleeding events within 6 months before the first treatment, such as esophageal or gastric variceal bleeding caused by portal hypertension. Untreated or incompletely treated esophageal or gastric varices that in the opinion of the investigator is at high risk of bleeding; 6. Suffering from clinically significant cardiovascular and cerebrovascular diseases: congestive heart failure, myocardial infarction or cerebrovascular accident, unstable arrhythmia or unstable angina with a New York College of Cardiology (NYHA) grade of grade 2 or above (including grade 2) within 3 months before the first treatment; History of congenital long QT syndrome or QT interval corrected at screening >500ms (calculated using Fridericia's method); 7. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, corticosteroids, immunosuppressants) within 2 years prior to the first treatment, while replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment; 8. Known positive human immunodeficiency virus (HIV) test or known history of active acquired immunodeficiency syndrome; 9. Prior allogeneic stem cell or solid organ transplantation; 10. Malignant tumors other than HCC within 5 years prior to the first treatment, except for malignant tumors with negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, superficial bladder cancer, etc.; 11. Pregnant or lactating women; 12. Concurrent enrollment in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study (defined as the time of first administration more than 4 weeks from the last dose of the previous clinical study or more than 5 half-lives of the investigational drug, whichever is shorter); 13. Systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressants within 2 weeks prior to the first treatment. Exceptions are the following: epinephrine replacement corticosteroids (prednisone< 10 mg/day or equivalent); Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactLunxiu Qin
Huashan Hospital, Fudan University
Outcome results
None listed