NCT07478302

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

March 12, 2026

Last Update Submit

April 29, 2026

Conditions

Advanced Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

  • Trough serum concentrations (C21d)

    Pharmacokinetics (PK) parameters.

    0 - 21 days.

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

    Pharmacokinetics (PK) parameters.

    0 - 12 days.

  • Area under curve up to 21 weeks (AUC0-21weeks)

    Pharmacokinetics (PK) parameters.

    0 - 12 weeks.

Secondary Outcomes (15)

  • Maximum blood concentration (Cmax)

    About 9 months.

  • Time to peak concentration (Tmax)

    About 9 months.

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

    About 9 months.

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

    About 9 months.

  • Elimination half-life (t1/2)

    About 9 months.

  • +10 more secondary outcomes

Study Arms (1)

SHR-2524 plus bevacizumab group

EXPERIMENTAL

SHR-2524 plus bevacizumab combined with other drugs.

Drug: SHR-2524 InjectionDrug: Bevacizumab Injection

Interventions

SHR-2524 InjectionDRUG

SHR-2524 injection.

SHR-2524 plus bevacizumab group
Bevacizumab InjectionDRUG

Bevacizumab injection.

SHR-2524 plus bevacizumab group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350002, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Yang Wu

CONTACT

+86-0518-82342973yang.wu.yw96@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

April 14, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

CN(2)