Hepatocellular Carcinoma (HCC)
Conditions
Interventions
Trial group:Interventional therapy+Sintilimab+Sintilimab+Icaritin
Control group:Interventional therapy+Sintilimab+Sintilimab
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 and 3 months. 14. Oral Drug Tolerance: Ability to swallow and absorb oral medications. 15. Organ Function: (1) Bone Marrow Function: Hemoglobin >=80 g/L, neutrophil count >=1.5 × 10^9/L, platelet count >=50 × 10^9/L. (2) Liver Function: Serum total bilirubin <=2 × upper limit of normal (ULN), AST, ALT, and alkaline phosphatase (ALP) <=5 × ULN. (3) Coagulation: INR <=2.3. (4) Thyroid Function: TSH within the normal range, or if abnormal, free T3 (FT3) and free T4 (FT4) within the normal range. 16. Blood Pressure Control: Blood pressure <=150/90 mmHg with up to three antihypertensive medications, with stable antihypertensive therapy for at least one week before the first treatment.
Exclusion criteria
Exclusion criteria: 1. Extrahepatic metastasis of primary liver cancer; 2. Diffuse liver cancer with an intrahepatic tumor burden >=50%; portal vein tumor thrombus (including superior mesenteric vein tumor thrombus, type IV), inferior vena cava tumor thrombus; 3. Participation in other drug clinical trials within the past 4 weeks; 4. Allergy to the active ingredients or excipients of the investigational drug; 5. History of liver resection, liver transplantation, interventional therapy, or other malignant tumors; 6. Pregnant or breastfeeding women; 7. Individuals of childbearing potential who are unwilling or unable to use effective contraceptive measures; 8. Patients with poorly controlled grade II or higher myocardial ischemia, myocardial infarction, or arrhythmia (including QTc interval >=470 ms); heart failure classified as grade III or IV according to NYHA standards, or left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) >ULN + 4 seconds or APTT >1.5 ULN), a tendency for bleeding, or patients currently receiving thrombolytic or anticoagulant therapy; 10. History of psychiatric disorders or substance abuse; 11. Patients with HIV infection; 12. Known allogeneic organ transplant (excluding corneal transplant) or allogeneic hematopoietic stem cell transplant; 13. Active infection; 14. Poor compliance, such as patients from transient populations; 15. Previous treatment with: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137); 16. Patients deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion success rate/ surgical conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-Free Survival;Overall Survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactDong Ke
Sichuan Provincial People's Hospital
Outcome results
None listed