HAIC + Atezolizumab Plus Bevacizumab in Unresectable HCC

Launched by RENJI HOSPITAL · Jun 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for people with liver cancer that cannot be removed by surgery, called unresectable hepatocellular carcinoma (HCC). The treatment includes a special type of chemotherapy delivered directly to the liver (HAIC) along with two medicines, atezolizumab and bevacizumab, that help the immune system fight cancer and block the growth of blood vessels that feed tumors. Researchers want to see how well this combination shrinks tumors and controls the disease, as well as how it affects patients’ survival, quality of life, and safety.

People who may be eligible to join are adults between 18 and 75 years old with confirmed liver cancer that cannot be surgically removed. They should be generally well enough to participate, with good liver function and no previous treatment with similar cancer medicines. Participants will need to have at least one tumor that can be measured to track changes during the trial. Women and men will need to take steps to prevent pregnancy during the study and for a short time afterward. If accepted, patients will receive this combination therapy and be closely monitored to see how their cancer responds and to check for any side effects. This trial is not yet recruiting, but it aims to find better ways to treat this form of liver cancer.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients between 18 and 75 years old, with no gender restrictions.
• • 2. Confirmed unresectable hepatocellular carcinoma (BCLC stage B/C) by histology, cytology, or clinical diagnosis.
• • 3. At least one measurable lesion based on RECIST version 1.1.
• • 4. Child-Pugh class A or B7.
• • 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• • 6. No prior systemic therapy received, with an expected survival ≥12 weeks.
• 7. Adequate organ function meeting the following criteria:
• • A. 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.
• • 8. 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.
• • 9. Willingness to voluntarily participate in the study, with good compliance and commitment to follow-up.
• Exclusion Criteria:
• • 1. Known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, sarcomatoid HCC, or fibrolamellar carcinoma.
• • 2. Concurrent autoimmune diseases, organ/hematopoietic stem cell transplantation history, or other malignancies.
• • 3. Impaired consciousness, inability to cooperate with treatment, or active psychiatric disorders.
• • 4. Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), bevacizumab, molecular targeted therapy, atezolizumab, or other PD-1/PD-L1 inhibitors received before enrollment.
• • 5. Major surgery, chemotherapy, radiotherapy, or systemic therapy for lesions received within 1 month before enrollment.
• • 6. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (\>10 mg/day prednisone or other equivalent drugs) within 14 days before enrollment.
• • 7. Severe esophageal varices or high risk of bleeding assessed by endoscopy.
• • 8. Evidence of decompensated liver function, including ascites, gastrointestinal bleeding, or hepatic encephalopathy.
• • 9. Severe organ dysfunction in major organs such as the liver, kidneys, heart, lungs, or brain.
• • 10. Other contraindications for interventional therapy, molecular targeted therapy, or immunotherapy.
• • 11. Inability to undergo scheduled follow-up or concurrent participation in other clinical trials that may interfere with this study.
• • 12. Other severe comorbidities deemed by the investigator to jeopardize patient safety or compromise study completion.