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

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 trial tests whether SHR-2524 combined with bevacizumab is safe and tolerable as a first-line treatment for adults with advanced unresectable hepatocellular carcinoma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Fuzhou, Fujian and 1 other locations)
• Trial ID: NCT07478302 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with advanced unresectable hepatocellular carcinoma (BCLC B or C), no prior systemic HCC therapy, at least one measurable lesion, Child‑Pugh A or B7, ECOG 0–1, and adequate organ function are the intended participants.

Not a fit: Patients with mixed hepatocellular‑cholangiocarcinoma or other excluded histologic HCC subtypes, active non‑HCC malignancies within five years, poor organ function, prior systemic HCC therapy, or worse Child‑Pugh/ECOG status are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the combination could offer a new first-line option that improves disease control for people with advanced unresectable hepatocellular carcinoma.

How similar studies have performed: Bevacizumab combinations (for example with immunotherapy) have shown clinical benefit in HCC, but SHR-2524 is an investigational agent and combinations with it are largely untested in humans.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian and 1 other locations

• 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

Conditions Advanced Unresectable Hepatocellular Carcinoma