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NCT Number: NCT07478302

A Study of SHR-2524 Plus Bevacizumab in the First-line Treatment of Advanced Hepatocellular Carcinoma

This study was a multicenter, open-label phase I clinical trial. This trial will include 36 patients with advanced unresectable hepatocellular carcinoma. Blood samples were obtained during the course of treatment to measure the relative parameter. All Investigational Medicinal Products (IMP) were discontinued after the total cycle.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 18 years old;
  • Advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or clinical diagnosis;
  • The Barcelona clinical liver cancer stage was B or C;
  • Has not previously received systemic antitumor therapy for HCC;
  • At least one measurable lesion according to RECIST v1.1 criteria;
  • Child-Pugh score of A or B7 ;
  • ECOG score 0 -1;
  • The expected survival time was ≥12 weeks;
  • The major organs functioned well;
  • Has signed the informed consent form.

Exclusion criteria

  • Hepatobiliary cell carcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma confirmed by histology or cytology;
  • Patients with active malignant tumors other than HCC within 5 years or at the same time; Localized tumors that had been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, could be enrolled;
  • Previous allogeneic organ transplantation (e.g., liver transplantation);
  • The current liver tumor burden is greater than 50% of the total liver volume;
  • CTCAE grade 3 bleeding had occurred within 6 months or CTCAE grade 2 nongastrointestinal bleeding had occurred within 3 months before the first dose;
  • Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the first dose;
  • Major vascular disease had occurred within 6 months before the first dose;
  • Current concomitant interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
  • Innate or acquired immune deficiency (such as HIV infection);
  • Severe infection occurred within 28 days before the first dose.

Treatment and study plan

SHR-2524 Injection

Drug

SHR-2524 injection.

Bevacizumab Injection

Drug

Bevacizumab injection.

Primary outcomes

  1. Trough serum concentrations (C21d)

    Time frame: 0 - 21 days.

    Pharmacokinetics (PK) parameters.

  2. Area under curve from Day 0 to Day 21 (AUC0-21d)

    Time frame: 0 - 12 days.

    Pharmacokinetics (PK) parameters.

  3. Area under curve up to 21 weeks (AUC0-21weeks)

    Time frame: 0 - 12 weeks.

    Pharmacokinetics (PK) parameters.

Secondary outcomes

  1. Maximum blood concentration (Cmax)

    Time frame: About 9 months.

    Pharmacokinetics (PK) parameters.

  2. Time to peak concentration (Tmax)

    Time frame: About 9 months.

    Pharmacokinetics (PK) parameters.

  3. Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t)

    Time frame: About 9 months.

    Pharmacokinetics (PK) parameters.

  4. Area under curve - Time curve from Time 0 to Infinity (AUC0-∞)

    Time frame: About 9 months.

    Pharmacokinetics (PK) parameters.

  5. Elimination half-life (t1/2)

    Time frame: About 9 months.

    Pharmacokinetics (PK) parameters.

  6. Rate of clearance (CL/F)

    Time frame: About 9 months.

    Pharmacokinetics (PK) parameters.

  7. Geometric mean of the apparent volume of distribution of the population (Vz/F)

    Time frame: About 9 months.

    Pharmacokinetics (PK) parameters.

  8. The number and percentage of anti-drug antibody (ADA) positive participants

    Time frame: About 9 months.

    Immunogenicity parameter.

  9. Adverse events (AEs)

    Time frame: About 9 months.

    Safety parameters: The type, incidence, grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v6.0), severity and correlation with Investigational Medicinal Products (IMP) of adverse events (AEs).

  10. Serious adverse events (SAEs)

    Time frame: About 9 months.

    Safety parameters: The type, incidence, grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v6.0), severity and correlation with Investigational Medicinal Products (IMP) of serious adverse events (SAEs).

  11. Investigator - assessed objective response rate (ORR) based on RECIST v1.1

    Time frame: About 9 months.

    Efficacy parameters.

  12. Investigator - assessed duration of response (DoR) based on RECIST v1.1

    Time frame: About 9 months.

    Efficacy parameters.

  13. Investigator - assessed disease control rate (DCR) based on RECIST v1.1

    Time frame: About 9 months.

    Efficacy parameters.

  14. Investigator - assessed progression-free survival (PFS) based on RECIST v1.1

    Time frame: About 9 months.

    Efficacy parameters.

  15. Investigator - assessed overall survival (OS) based on RECIST v1.1

    Time frame: About 9 months.

    Efficacy parameters.

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

To Investigate the Pharmacokinetics, Safety, Tolerability and Efficacy of SHR-2524 Combined With Bevacizumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC) in an Open-label, Multicenter Phase I Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
May 1, 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.

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