Initially resectable hepatocellular carcinoma that has not received prior anticancer treatment.
Conditions
Interventions
Experimental group:Hepatic Resection After Initial Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib.
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed written informed consent. 2. Aged >= 18 years; male or female. 3. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (HCC) according to EASL/AASLD criteria. 4. CNLC stage Ib, IIa, IIb, or IIIa HCC (excluding patients with main portal vein tumor thrombus); 5. Presence of vascular invasion and no extrahepatic metastasis, including PVTT (Vp1–Vp3), HVTT, or IVCTT. 6. No prior systemic treatment for HCC, including chemotherapy, targeted therapy, or immunotherapy. 7. Child-Pugh class A liver function. 8. ECOG performance status 0–1. 9. Adequate organ function: a. ANC >= 1.5 × 10^9/L;Platelet count >= 75 × 10^9/L; Hemoglobin >= 90 g/L. b. Albumin >= 30 g/L; Total bilirubin 50 mL/min. c. INR = 2+, 24-hour urine protein = 10-fold reduction after antiviral treatment. 11. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after study completion. Male participants must also use effective contraception during the study and for 6 months after study completion.
Exclusion criteria
Exclusion criteria: 1. Intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, fibrolamellar carcinoma, or any other active malignancy within the past 5 years (except HCC). 2. Severe allergy to iodinated contrast agents that prevents HAIC treatment. 3. Planned or prior organ transplantation or allogeneic bone marrow transplantation. 4. Treatment with another investigational drug within 28 days before study treatment. 5. Current or prior central nervous system metastases. 6. History of hepatic encephalopathy. 7. Current interstitial pneumonitis or interstitial lung disease. 8. Active autoimmune disease or history of autoimmune disease with risk of recurrence. 9. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 14 days before study treatment. 10. Severe infection within 4 weeks before study treatment. 11. Gastrointestinal bleeding within 6 months before study treatment or a known risk of gastrointestinal bleeding. 12. Known hereditary or acquired bleeding disorders or thrombotic tendency. 13. Uncontrolled clinically significant cardiac disease or symptoms. 14. Moderate or severe ascites requiring therapeutic drainage or paracentesis. 15. Major vascular disease within 6 months before study treatment. 16. Inability to swallow oral medication, malabsorption syndrome, or any condition affecting gastrointestinal absorption. 17. Known hypersensitivity to any study drug, its excipients, monoclonal antibodies, or anti-angiogenic agents. 18. Any other serious acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase study risk, interfere with study results, or make the patient unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure (TTF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);R0 Resection Rate;Time to progression (TTP);Major Pathological Response (MPR);Objective Response Rate (ORR);Best Response (BOR);Overall Survival (OS);Duration of Response (DoR);Pathological Complete Response (pCR);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactWei Dai
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed