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

A Randomized, Open-label, Multicenter Phase II Study of SHR-8068 Combined With Adebrelimab and Apatinib for Perioperative Treatment in Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk
• Intervention / Treatment: Drug: SHR-8068 Injection; Drug: Adebrelimab Injection; Drug: Apatinib Mesylate Tablets

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xin Shi; Phone Number: +86-0518-82342973; Email: xin.shi.xs3@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital Fudan University
      • Principal Investigator: Jian Zhou
      • Contact: Jian Zhou; Phone Number: +86-021-64041990; Email: zhou.jian@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-8068 + Adebrelimab + Apatinib Group; SHR-8068, Adebrelimab, Apatinib.	Drug: SHR-8068 Injection; SHR-8068 injection.; Drug: Adebrelimab Injection; Adebrelimab injection.; Drug: Apatinib Mesylate Tablets; Apatinib mesylate tablets.
Active Comparator: Adebrelimab + Apatinib Group; Adebrelimab, Apatinib.	Drug: Adebrelimab Injection; Adebrelimab injection.; Drug: Apatinib Mesylate Tablets; Apatinib mesylate tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major pathological response (MPR (70%)) rate.	MPR (70%) is defined as residual viable tumor cells <= 30% in the tumor bed.	After surgery, approximately 3 months.

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: apatinib
• Other Study ID Numbers: SHR-8068-208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No