Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular… (NCT07761286) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma
China288 participantsStarted 2026-09-30
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Child-Pugh score \<7 and no history of hepatic encephalopathy.
. No prior systemic anti-tumor therapy for HCC. Prior systemic therapy administered in the neoadjuvant or adjuvant setting is permitted, provided that the time from the last dose of prior therapy to tumor recurrence is ≥6 months.
. At least one measurable lesion per RECIST Version 1.1. Lesions previously treated with interventional therapy, radiotherapy or ablation may be counted as measurable lesions if clear disease progression is documented per RECIST v1.1 and the lesion meets measurable lesion criteria.
. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
. 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).
. Received live vaccines within 4 weeks prior to the first study drug administration. Note: Seasonal influenza vaccines are inactivated vaccines in general and are permitted. Intranasal influenza vaccines are live vaccines and are prohibited.
. Received strong CYP3A4 inhibitors/inducers, or OATP1B1/OATP1B3 inhibitors within 14 days prior to the first study drug administration, or require continuous use of such agents throughout the study period.
. Adverse reactions from prior anti-tumor therapy have not recovered to Grade ≤1 per NCI CTCAE v6.0 (excluding toxicities judged by the Investigator to carry no safety risks, such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stabilized with hormone replacement therapy, etc.).
. History of or current central nervous system metastases and/or carcinomatous meningitis; current untreated spinal cord compression (excluding participants with previously diagnosed treated spinal cord compression with documented clinically stable symptoms for more than 2 weeks prior to screening).