Study on the Combined Treatment of Hepatocellular Carcinoma With Envafolimab, Suvemcitug and HAIC Conversion

Prior treatment

• Subjects who have previously or concurrently suffered from other malignant tumors;
• Patients who have received systemic anti-tumor treatment in the past;
• Those who are currently candidates for liver transplantation or have undergone liver transplantation;
• Subjects who are known to have previously been allergic to large molecule protein preparations or the components of the applied drugs;
• Subjects with any active autoimmune diseases or a history of autoimmune diseases (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaryitis, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism/hypothyroidism), and the use of drugs that cannot maintain thyroid function within the normal range, or previous thyroid surgery, and long-term thyroid hormone replacement therapy is required after the surgery; subjects with vitiligo or who had completely resolved asthma in childhood and do not require any intervention in adulthood can be included; subjects with asthma who require bronchodilators for medical intervention cannot be included);
• Subjects who are currently using immunosuppressants, or systemic, or absorbable local hormone treatments to achieve immunosuppression purposes (dose \> 10mg/day prednisone or other drugs with equivalent efficacy), and are still using them within 2 weeks before enrollment;
• Subjects who are using traditional Chinese medicine or other immunomodulatory agents within 2 weeks before enrollment;
• Less than 4 weeks before the study medication, or may have received live vaccines during the study period;

Other illness

• Those with a risk of bleeding, or coagulation dysfunction, or are undergoing thrombolytic therapy; or have experienced esophageal or gastric variceal bleeding within the past 6 months;
• Have poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure (2) unstable angina pectoris (3) having had a myocardial infarction within 1 year (4) having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;
• Subjects with known history of substance abuse of psychotropic drugs, alcoholism or drug abuse;

Lab values

• Subjects with congenital or acquired immune deficiencies, such as HIV-infected individuals, or active hepatitis (transaminase does not meet the inclusion criteria, for hepatitis B: HBV DNA ≥ 2000 IU/ml or ≥ 104 copies/ml; for hepatitis C: HCV RNA ≥ 2000 IU/ml or ≥ 104 copies/ml; after nucleotide antiviral treatment, below the above standards can be included); chronic hepatitis B virus carriers, HBV DNA \< 104 IU/ml, can be enrolled during the trial period if they must receive antiviral treatment simultaneously;
• The investigator considers it necessary to exclude from this study, for example, if the subject is judged by the investigator to have other factors that may cause the study to be prematurely terminated, such as, other serious diseases (including mental disorders) that require combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect the safety of the subject, or the collection of data and samples.

Other

• Those who refuse to sign the informed consent form or refuse to undergo follow-up;

• Sign a written informed consent form before enrollment;
• Age 18-75 years old;
• Diagnosed with hepatocellular carcinoma (HCC) by clinical assessment;
• Patients with stage IV or III unresectable liver cancer;
• Have measurable lesions (according to the RECIST 1.1 standard, non-lymph node lesions with CT scan diameter ≥ 10 mm, lymph node lesions with CT scan diameter ≥ 15 mm);
• Have not received any systemic anti-tumor treatment before, including but not limited to immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine treatment;
• Child-Pugh score ≤ 7 points;
• Have sufficient organ function; 1) Blood routine: White blood cell (WBC) ≥ 3.5 × 10\^9/L, absolute neutrophil count (ANC) 1.5 × 10\^9/L, platelet (PLT) ≥ 100 × 10\^9/L, hemoglobin (HGB) ≥ 90 g/L; 2) Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; 3) Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 mL/min (using the standard Cockcroft-Gault formula); 4) Coagulation function: International normalized ratio (INR) ≤ 1.5 / PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation treatment, as long as PT and INR are within the range prescribed by the anticoagulant drug, it is acceptable.
  • 10\. Estimated survival period ≥ 3 months; 11. Pregnant women should agree to use contraceptive measures (such as intrauterine device, contraceptive pills, or condoms) during the study period and within 6 months after the study; the serum HCG test should be negative within 7 days before enrollment, and must be non-lactating patients; men should agree to use contraceptive measures during the study period and within 6 months after the study.