HAIC + Atezolizumab Plus Bevacizumab in Unresectable HCC

Korábbi kezelés

• Concurrent autoimmune diseases, organ/hematopoietic stem cell transplantation history, or other malignancies.
• Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), bevacizumab, molecular targeted therapy, atezolizumab, or other PD-1/PD-L1 inhibitors received before enrollment.
• Major surgery, chemotherapy, radiotherapy, or systemic therapy for lesions received within 1 month before enrollment.
• Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (\>10 mg/day prednisone or other equivalent drugs) within 14 days before enrollment.
• Other contraindications for interventional therapy, molecular targeted therapy, or immunotherapy.
• Inability to undergo scheduled follow-up or concurrent participation in other clinical trials that may interfere with this study.

Más betegség

• Impaired consciousness, inability to cooperate with treatment, or active psychiatric disorders.
• Severe esophageal varices or high risk of bleeding assessed by endoscopy.
• Evidence of decompensated liver function, including ascites, gastrointestinal bleeding, or hepatic encephalopathy.
• Severe organ dysfunction in major organs such as the liver, kidneys, heart, lungs, or brain.

Egyéb

• Known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, sarcomatoid HCC, or fibrolamellar carcinoma.
• Other severe comorbidities deemed by the investigator to jeopardize patient safety or compromise study completion.

• Patients between 18 and 75 years old, with no gender restrictions.
• Confirmed unresectable hepatocellular carcinoma (BCLC stage B/C) by histology, cytology, or clinical diagnosis.
• At least one measurable lesion based on RECIST version 1.1.
• Child-Pugh class A or B7.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• No prior systemic therapy received, with an expected survival ≥12 weeks.
• Adequate organ function meeting the following criteria:
  • Hematological parameters (without blood transfusion within 14 days): Hemoglobin (Hb) ≥80 g/L, White blood cell count (WBC) ≥3 × 10⁹/L, Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, Platelet count (PLT) ≥50 × 10⁹/L; B. Biochemical parameters: Total bilirubin (TBIL) \<1.5 × upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<5 × ULN, Serum creatinine (Cr) ≤1.5 × ULN.
• Contraception requirements: Women of childbearing age must have a negative serum or urine pregnancy test (HCG) within 7 days before enrollment and agree to use effective contraceptive methods during the trial period and for 8 weeks after the last dose. Men must either have undergone surgical sterilization or agree to use appropriate contraceptive methods during the trial period and for 8 weeks after the last dose.
• Willingness to voluntarily participate in the study, with good compliance and commitment to follow-up.