Advanced Unresectable Hepatocellular CarcinomaPhase 1NCT07478302
A Study of SHR-2524 Plus Bevacizumab in the First-line Treatment of Advanced Hepatocellular Carcinoma
A Phase 1 study testing SHR-2524 Injection and Bevacizumab Injection in people with Advanced Unresectable Hepatocellular Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Unresectable Hepatocellular Carcinoma
- What is being tested?
- SHR-2524 Injection and Bevacizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesChina
- Study dates
- 14 Apr 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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 ;
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- ECOG score 0 -1;
- The expected survival time was ≥12 weeks;
- The major organs functioned well;
- Has signed the informed consent form.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350002
Yongyi Zeng, +86-13805083802, lamp197311@126.com
Yongyi Zeng
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Tao Peng, +86-0771-5356528, p98720p@163.com
Tao Peng
About this study
Official 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
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.
- Being tested
- SHR-2524 Injection, Bevacizumab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2524 InjectionDrug
SHR-2524 injection.
Bevacizumab InjectionDrug
Bevacizumab injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-2524 plus bevacizumab group | Experimental | SHR-2524 plus bevacizumab combined with other drugs. Receives: Drug: SHR-2524 Injection; Drug: Bevacizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough serum concentrations (C21d)
Pharmacokinetics (PK) parameters.
Measured: 0 - 21 days.
Area under curve from Day 0 to Day 21 (AUC0-21d)
Pharmacokinetics (PK) parameters.
Measured: 0 - 12 days.
Area under curve up to 21 weeks (AUC0-21weeks)
Pharmacokinetics (PK) parameters.
Measured: 0 - 12 weeks.
Secondary outcomes (15)
Maximum blood concentration (Cmax)
Pharmacokinetics (PK) parameters.
Measured: About 9 months.
Time to peak concentration (Tmax)
Pharmacokinetics (PK) parameters.
Measured: About 9 months.
Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t)
Pharmacokinetics (PK) parameters.
Measured: About 9 months.
Area under curve - Time curve from Time 0 to Infinity (AUC0-∞)
Pharmacokinetics (PK) parameters.
Measured: About 9 months.
Elimination half-life (t1/2)
Pharmacokinetics (PK) parameters.
Measured: About 9 months.
Rate of clearance (CL/F)
Pharmacokinetics (PK) parameters.
Measured: About 9 months.
Geometric mean of the apparent volume of distribution of the population (Vz/F)
Pharmacokinetics (PK) parameters.
Measured: About 9 months.
The number and percentage of anti-drug antibody (ADA) positive participants
Immunogenicity parameter.
Measured: About 9 months.
Adverse events (AEs)
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).
Measured: About 9 months.
Serious adverse events (SAEs)
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).
Measured: About 9 months.
Investigator - assessed objective response rate (ORR) based on RECIST v1.1
Efficacy parameters.
Measured: About 9 months.
Investigator - assessed duration of response (DoR) based on RECIST v1.1
Efficacy parameters.
Measured: About 9 months.
Investigator - assessed disease control rate (DCR) based on RECIST v1.1
Efficacy parameters.
Measured: About 9 months.
Investigator - assessed progression-free survival (PFS) based on RECIST v1.1
Efficacy parameters.
Measured: About 9 months.
Investigator - assessed overall survival (OS) based on RECIST v1.1
Efficacy parameters.
Measured: About 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start14 Apr 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478302
- Sponsor's protocol ID
- SHR-2524-101
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07478302
- Acronym / sponsor ID
- SHR-2524-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-2524 plus bevacizumab group | Experimental | Drug: SHR-2524 Injection, Drug: Bevacizumab InjectionSHR-2524 plus bevacizumab combined with other drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2524 InjectionSHR-2524 injection. | Drug | SHR-2524 plus bevacizumab group |
| Bevacizumab InjectionBevacizumab injection. | Drug | SHR-2524 plus bevacizumab group |
Primary outcome
Trough serum concentrations (C21d)
Time frame: 0 - 21 days.
Pharmacokinetics (PK) parameters.
Area under curve from Day 0 to Day 21 (AUC0-21d)
Time frame: 0 - 12 days.
Pharmacokinetics (PK) parameters.
Area under curve up to 21 weeks (AUC0-21weeks)
Time frame: 0 - 12 weeks.
Pharmacokinetics (PK) parameters.
15 secondary outcomes
Maximum blood concentration (Cmax)
Time frame: About 9 months.
Time to peak concentration (Tmax)
Time frame: About 9 months.
Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t)
Time frame: About 9 months.
Area under curve - Time curve from Time 0 to Infinity (AUC0-∞)
Time frame: About 9 months.
Elimination half-life (t1/2)
Time frame: About 9 months.
Rate of clearance (CL/F)
Time frame: About 9 months.
Geometric mean of the apparent volume of distribution of the population (Vz/F)
Time frame: About 9 months.
The number and percentage of anti-drug antibody (ADA) positive participants
Time frame: About 9 months.
Adverse events (AEs)
Time frame: About 9 months.
Serious adverse events (SAEs)
Time frame: About 9 months.
Investigator - assessed objective response rate (ORR) based on RECIST v1.1
Time frame: About 9 months.
Investigator - assessed duration of response (DoR) based on RECIST v1.1
Time frame: About 9 months.
Investigator - assessed disease control rate (DCR) based on RECIST v1.1
Time frame: About 9 months.
Investigator - assessed progression-free survival (PFS) based on RECIST v1.1
Time frame: About 9 months.
Investigator - assessed overall survival (OS) based on RECIST v1.1
Time frame: About 9 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-2524 Injection and Bevacizumab Injection in people with Advanced Unresectable Hepatocellular Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Wu (+86-0518-82342973, yang.wu.yw96@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough serum concentrations (C21d) (time frame: 0 - 21 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.