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NCT Number: NCT07682272

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location contact

Jian Zhou

CONTACT

[email protected]

+86-021-64041990

Jian Zhou

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-8068 Injection

Drug

SHR-8068 injection.

Adebrelimab Injection

Drug

Adebrelimab injection.

Apatinib Mesylate Tablets

Drug

Apatinib mesylate tablets.

Primary outcomes

  1. Major pathological response (MPR (70%)) rate.

    Time frame: After surgery, approximately 3 months.

    MPR (70%) is defined as residual viable tumor cells <= 30% in the tumor bed.

Secondary outcomes

  1. Event-free survival (EFS).

    Time frame: From randomization to event, approximately 2 years.

  2. 12-month and 24-month Event-free survival (EFS) rate.

    Time frame: From randomization to event, approximately 2 years.

  3. R0 resection rate.

    Time frame: After surgery, approximately 3 months.

  4. Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0.

    Time frame: Approximately 2 years.

  5. Safety endpoints, including surgical complications by Clavien-Dindo.

    Time frame: Approximately 2 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.