Hepatocellular Carcinoma,HCC
Conditions
Interventions
Intervention group:Iparomlimab/Tuvonralimab Combined TACE neoadjuvant therapy
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old; 2. Resectable primary hepatocellular carcinoma at BCLC stage A/B; 3. Translation: Child - Pugh liver function classification is grade A and good grade B ( 5 cm; (3) Alpha-fetoprotein (AFP) > 400 µg/L; 6. According to the RECIST v1.1 criteria, the lesions should be measurable or evaluable. The study subjects must have at least one untreated target lesion that can be measured by CT or MRI. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 1; 8. Expected survival time >= 3 months; 9. Before the first use of the drug, the function levels of important organs must meet the following conditions (without blood transfusion or use of blood products and without correction with G - CSF or other hematopoietic stimulating factors within 14 days before obtaining laboratory test results): (1) Hemoglobin >= 9.0 g/dL; (2) Absolute neutrophil count (ANC) >= 1,000/mm³; (3) Platelet count >= 50,000/µL; (4) Total bilirubin 2.8 g/dL; (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 50%. 10. Fertile women and men must agree to use highly effective contraceptive measures from the signing of the informed consent form until at least 5 months (for women) or 7 months (for men) after the last administration of the study drug. Women of childbearing age must not be pregnant or breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Previously received systemic treatment for hepatocellular carcinoma; 2. Tumor rupture or bleeding, suspected abdominal cavity metastasis; 3. Underwent major surgery, open biopsy, or had severe trauma with poor wound healing within 6 weeks before enrollment; 4. History of allogeneic organ transplantation; 5. Currently participating in other clinical trials; 6. Active or previously documented autoimmune diseases or inflammatory diseases (including inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis syndrome, rheumatoid arthritis, pituitary inflammation, uveitis, etc.). The following cases are excluded: vitiligo or alopecia, hypothyroidism (e.g., secondary to Hashimoto's syndrome) and stable under hormone replacement therapy, any chronic skin diseases that do not require systemic treatment, or celiac disease controlled only by diet; 7. History of similar allergic reactions to the chemical or biological components of Aipalolitoworelimab or other immune checkpoint inhibitors; 8. Uncontrollable comorbidities, including but not limited to: persistent or active infections (including tuberculosis), uncontrollable hypertension (defined as blood pressure >140/90 mmHg during screening despite drug management), interstitial lung disease, severe chronic gastrointestinal diseases related to diarrhea, or mental illness/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events, or impair the patient's ability to sign the written informed consent form; 9. History of hepatic encephalopathy, refractory ascites, or esophageal - gastric varices at high risk of bleeding. Upper gastrointestinal bleeding within one year before the first administration of the study drug. 10. Untreated active hepatitis B infection (hepatitis B surface antigen [HBsAg] positive and hepatitis B virus DNA >=1000 international units/ml). Patients with a history of past or resolved hepatitis B infection (defined as the presence of hepatitis B core antibody [anti - HBc] and the absence of HBsAg) are eligible. Active hepatitis C infection (hepatitis C antibody positive and hepatitis C virus RNA above the lower limit of detection). 11. Primary brain tumors (except meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizures that cannot be controlled with standard drug treatment, or a history of stroke within one year before the first administration of the study drug. 12. History of active primary immunodeficiency. 13. Positive human immunodeficiency virus (HIV) test or known to have acquired immunodeficiency syndrome (AIDS). 14. Use of immunosuppressive drugs within 14 days before the first administration of the study drug. The following cases are excluded: intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra - articular injections). Systemic corticosteroids at a physiological dose of no more than 10 mg of prednisone or its equivalent per day. 15. Vaccinated with live attenuated vaccines within 30 days before the first administration of the study drug. Note: If patients are enrolled, they should not receive live vaccines during the period of receiving the study drug and for at least 30 days after the last administration of the study drug. 16. Received systemic immunostimulant treatment within 14 days before the first administration of the study drug. 17. History of severe systemic diseases, including myocardial infarction or unstable angina within 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological response,MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rat,ORR;Disease-Free Survival; | — |
Countries
China
Contacts
Public ContactLiu Enyu
Qilu Hospital of Shandong University
Outcome results
None listed