A Trial of SHR-8068 Combined With Adebrelimab and Apatinib in Perioperative Treatment of Resectable Hepatocellular Carcinoma

• SHR-8068 Injection (Drug): SHR-8068 injection.
• Adebrelimab Injection (Drug): Adebrelimab injection.
• Apatinib Mesylate Tablets (Drug): Apatinib mesylate tablets.

Primary outcomes

• Major pathological response (MPR (70%)) rate. [After surgery, approximately 3 months.]: MPR (70%) is defined as residual viable tumor cells <= 30% in the tumor bed.

Secondary outcomes

• Event-free survival (EFS). [From randomization to event, approximately 2 years.]
• 12-month and 24-month Event-free survival (EFS) rate. [From randomization to event, approximately 2 years.]
• R0 resection rate. [After surgery, approximately 3 months.]
• Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0. [Approximately 2 years.]
• Safety endpoints, including surgical complications by Clavien-Dindo. [Approximately 2 years.]

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

1. Subjects who voluntarily participate in this study and sign the informed consent form.
2. Age from 18 to 70, male or female.
3. Histopathologically/cytologically confirmed or clinically diagnosed with hepatocellular carcinoma (HCC).
4. At least one measurable lesion based on RECIST v1.1.
5. No prior systemic antitumor therapy for HCC.
6. ECOG Performance Status (PS) score of 0-1.
7. Child-Pugh liver function class A.
8. Expected survival at least 3 months.
9. Adequate organ function.
10. Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.

Exclusion Criteria:

1. Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
2. Other malignancies within the past 5 years or concurrent malignancy.
3. Known history of severe hypersensitivity reaction to any monoclonal antibody.
4. Previous or current central nervous system metastases.
5. Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage.
6. Hypertension that cannot be well controlled with antihypertensive medication.
7. Poorly controlled cardiac symptoms or heart disease.
8. Known hereditary or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency.
9. Arterial thrombotic or embolic events within 6 months before enrollment.
10. Any other condition that, in the investigator's judgment, may affect the study results or lead to premature termination of the study.