Liver cancer
Conditions
Interventions
Experimental group:TACE combined with Iparomlimab and Tuvonralimab and dronafibron
Sponsors
The First Affiliated Hospital of University of science and technology of China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. Age >=18 years old, no gender restrictions; 3. Hepatocellular carcinoma (HCC) confirmed by histopathology, cytology, or imaging; 4. Subjects with CNLC IIb/IIIa stage or BCLC B/C stage hepatocellular carcinoma; 5. Determined by the treating physician to be suitable for transarterial chemoembolization (TACE) combined with systemic drug therapy; 6. Child-Pugh score: Class A–B (= 3 months; 11. No prior systemic therapy; 12. Patients with active hepatitis B virus (HBV) infection must receive at least 14 days of anti-HBV therapy (per local standard of care, e.g., entecavir) prior to study treatment initiation and agree to continue antiviral therapy throughout the study period; patients with hepatitis C virus (HCV) RNA positivity must receive antiviral therapy per local standard of care guidelines and have liver function within CTCAE Grade 1 elevation; 13. Female subjects of childbearing potential or male subjects with female sexual partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months post-treatment. 14. Normal major organ function, meeting the following criteria: (1) Complete blood count: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 50 × 10^9/L; Hemoglobin (HGB) >= 85 g/L. (2) Liver function: Serum total bilirubin (TBIL) =28 g/L; Alkaline phosphatase (ALP) =50 mL/min (Cockcroft-Gault formula); (4) Coagulation function: International Normalized Ratio (INR) <=2; Activated Partial Thromboplastin Time (APTT) <= 1.5 times ULN. 15. Patients deemed likely to benefit by the investigator.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of other malignancies within 5 years prior to signing informed consent (excluding cured basal cell skin cancer, papillary thyroid carcinoma, etc.); 2. Contraindications to TACE, immunotherapy, or targeted therapy, such as severe liver cirrhosis, moderate or greater ascites, Child-Pugh C-grade liver function, or unimproved liver function despite hepatoprotective therapy; 3. Portal vein tumor thrombus classified as Vp4 (LCSGJ) or Cheng IV; 4. Prior systemic therapy; 5. Systemic infection or other severe infection requiring >7 days of intravenous antibiotics within 2 weeks prior to first dosing, or unexplained fever >38.5°C (excluding tumor-related fever as determined by the investigator) during screening or prior to enrollment; 6. Diagnosed with immunodeficiency or having received systemic steroid therapy, any other form of immunosuppressive therapy, or immunomodulatory therapy within 7 days prior to the first study drug dose. 7. Symptomatic central nervous system (CNS) metastases; 8. Active or potentially recurrent autoimmune disease; 9. Hypertension uncontrolled despite antihypertensive therapy (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg) (based on the mean of >=2 BP measurements); prior hypertensive crisis or hypertensive encephalopathy; 10. Evidence of bleeding tendency or severe coagulation disorder; 11. Past and/or current interstitial lung disease, pneumoconiosis, or radiation pneumonitis deemed clinically significant by the investigator, or severe pulmonary impairment that may interfere with detection and management of suspected drug-related pulmonary toxicity; 12. HIV-positive patients; known active tuberculosis within one year prior to first study treatment; known active syphilis infection; 13. Major surgery within one month prior to first study drug administration, or active ulcers or wounds not fully healed (excluding central venous catheter placement, tumor tissue biopsy, or nasogastric tube insertion); 14. Received a live vaccine within 4 weeks prior to the first dose; 15. Participated in another clinical study and received other investigational medicinal products within 4 weeks prior to the first dose; 16. Pregnant or lactating women; 17. Known history of allergy to macromolecular protein preparations. Contraindications or allergies to any component of the study drug; 18. History of clinically significant thyroid disease or current thyroid disease, including but not limited to: uncontrolled hyperthyroidism or hypothyroidism; 19. Patients deemed ineligible for enrollment by the investigator due to factors that may increase study-related risks or interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Objective response rate, ORR;Disease control rate, DCR;Disease-free survival, DFS;R0 resection rate;Overall survival, OS;Adverse events, AE; | — |
Countries
China
Contacts
Public ContactYongsheng Ge
The First Affiliated Hospital of University of science and technology of China
Outcome results
None listed