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Not yet recruiting NCT07682272

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

Phase II Interventional Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-8068 Injection, Adebrelimab Injection, Apatinib Mesylate Tablets.
Who it may be relevant to
Registry conditions: Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Primary outcome measures

  • Major pathological response (MPR (70%)) rate. [Time frame: After surgery, approximately 3 months.]
Secondary outcome measures (5)
  • Event-free survival (EFS). [Time frame: From randomization to event, approximately 2 years.]
  • 12-month and 24-month Event-free survival (EFS) rate. [Time frame: From randomization to event, approximately 2 years.]
  • R0 resection rate. [Time frame: After surgery, approximately 3 months.]
  • Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0. [Time frame: Approximately 2 years.]
  • Safety endpoints, including surgical complications by Clavien-Dindo. [Time frame: Approximately 2 years.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT07682272 · SHR-8068-208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗