This is an open-label, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of combination therapy with SYS6090 Injection in participants with hepatocellular carcinoma (HCC).
The participant voluntarily signs the informed consent form.
Aged ≥18 years at the time of informed consent acquisition.
Confirmed diagnosis of hepatocellular carcinoma (HCC) via histopathology, cytopathology, or clinical diagnosis in accordance with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2026 Edition).
Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B unsuitable for curative surgery and/or locoregional therapy.
Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma.
Received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any investigational trial intervention within 4 weeks prior to the first study drug administration or within 5 half-lives of the most recent anti-tumor agent (whichever is shorter); or received Chinese patent medicines with anti-tumor indications, palliative radiotherapy, or locoregional therapy within 14 days prior to the first study drug administration.
Underwent major visceral surgery (excluding core needle biopsy) or sustained severe trauma within 4 weeks prior to the first study drug administration, or planned elective surgery during the study period.
Received systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first study drug administration, except for the following scenarios: physiologic replacement doses of hydrocortisone or equivalent hormones (i.e., prednisone ≤10 mg/day or equivalent); topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-course corticosteroids for prophylaxis (e.g., prophylaxis against contrast medium allergy).
Factorial
SYS6090 Injection + Bevacizumab Injection
DrugSYS6090 in Combination with Bevacizumab 15mg/kg
SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection
DrugSYS6090 in Combination with SYS6043 and Bevacizumab 15mg/kg
Bevacizumab Injection + Sintilimab Injection
DrugBevacizumab 15mg/kg in Combination with Sintilimab 200mg, intravenous infusion, every 3 weeks.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluated incidence and severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per NCI-CTCAE version 6.0, including abnormal laboratory tests, ECG parameters and vital signs from screening through end of safety follow-up.
Overall response rate (ORR)
ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with at least one visit confirmed complete response (CR) or partial response (PR).
DLT；RP2D and MTD
The Phase Ib study will explore the DLTs and MTD of SYS6090 combination therapy, and the RP2D will be determined based on the results from the Phase Ib study.
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This trial is not recruiting at the moment. You can still explore other options:
