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

NCT07682272 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-8068-208
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

Study Arms (2)

SHR-8068 + Adebrelimab + Apatinib Group

EXPERIMENTAL

SHR-8068, Adebrelimab, Apatinib.

Drug: SHR-8068 Injection; Drug: Adebrelimab Injection; Drug: Apatinib Mesylate Tablets

Adebrelimab + Apatinib Group

ACTIVE COMPARATOR

Adebrelimab, Apatinib.

Drug: Adebrelimab Injection; Drug: Apatinib Mesylate Tablets

Interventions

SHR-8068 Injection DRUG

SHR-8068 injection.

SHR-8068 + Adebrelimab + Apatinib Group

Adebrelimab Injection DRUG

Adebrelimab injection.

Adebrelimab + Apatinib Group; SHR-8068 + Adebrelimab + Apatinib Group

Apatinib Mesylate Tablets DRUG

Apatinib mesylate tablets.

Adebrelimab + Apatinib Group; SHR-8068 + Adebrelimab + Apatinib Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

apatinib

Central Study Contacts

Xin Shi

CONTACT

+86-0518-82342973; xin.shi.xs3@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1 into two cohorts in an open-label, multicenter, phase II perioperative study.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

CN (1)