SHR-2524 plus bevacizumab as first-line treatment for advanced hepatocellular carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open‑label phase I trial enrolls 36 adults with advanced unresectable hepatocellular carcinoma who have not received prior systemic therapy. Participants receive SHR-2524 together with bevacizumab and undergo regular clinical and imaging assessments for measurable disease per RECIST v1.1. Blood samples are collected during treatment to measure pharmacodynamic markers and other biomarker changes. The primary focus is dose finding and safety/tolerability while gathering early signals of clinical activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Hepatobiliary cell carcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma confirmed by histology or cytology;
2. 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;
3. Previous allogeneic organ transplantation (e.g., liver transplantation);
4. The current liver tumor burden is greater than 50% of the total liver volume;
5. CTCAE grade 3 bleeding had occurred within 6 months or CTCAE grade 2 nongastrointestinal bleeding had occurred within 3 months before the first dose;
6. Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the first dose;
7. Major vascular disease had occurred within 6 months before the first dose;
8. Current concomitant interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
9. Innate or acquired immune deficiency (such as HIV infection);
10. Severe infection occurred within 28 days before the first dose.

Where it's running

• Mengchao Hepatobiliary Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting

Study contacts

• Study coordinator: Yang Wu
• Email: yang.wu.yw96@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.