Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk
Conditions
Brief summary
This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk.
Interventions
SHR-8068 injection.
Adebrelimab injection.
Apatinib mesylate tablets.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomized 1:1 into two cohorts in an open-label, multicenter, phase II perioperative study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Contacts
CONTACTXin Shi
Outcome results
None listed