Hepatocellular carcinoma
Conditions
Interventions
Low-dose group:Take oral sialic acid (250 mg/d) at a fixed time daily
High-dose group:Take oral sialic acid (500 mg/d) at a fixed time daily
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-70 years old, male and female are not restricted 2. Diagnosed as unresectable advanced hepatocellular carcinoma by histopathology or imaging 3. Ineligible for curative surgery or local ablation therapy 4. Planned to receive or currently undergoing PD-1 + TKI combination therapy, with a clinical response of stable disease (SD) 5. At least one measurable lesion that meets the evaluation criteria of RECIST v1.1 or mRECIST 6. ECOG performance status score of 0-2 7. Estimated survival time >= 3 months 8. Good organ function meeting the following laboratory criteria (within 7 days before screening): ANC >= 1.5×10^9/L; Platelets>= 75×10^9/L; Hemoglobin >=90g/L; ALT/AST=50mL/min 9. Able to understand the study objectives and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known active autoimmune disease or currently receiving systemic immunosuppressive therapy (e.g., high-dose glucocorticoids, cyclosporine, tacrolimus, etc.); 2. History of or current severe central nervous system disorders, including but not limited to seizures, progressive neurological diseases, or brain metastases; 3. Concurrent untreated malignancy, except for localized basal cell carcinoma of the skin or cervical carcinoma in situ that has been cured for at least 5 years; 4. Presence of any of the following serious medical conditions that may compromise study intervention safety or interfere with outcome assessment: (1) Uncontrolled hypertension, coronary artery disease, congestive heart failure, or severe arrhythmias; (2) Active pulmonary infection or tuberculosis; (3) Active hepatitis (HBV DNA > 2,000 IU/mL or ALT > 5×ULN), or co-infection with HCV or HIV; (4) Significant renal insufficiency (CrCl < 50 mL/min); 5. Pregnant or lactating women, or women of childbearing potential or men with female partners of childbearing potential who are not using effective contraception during screening; 6. Known hypersensitivity to sialic acid or any components of the study product; 7. Significant gastrointestinal absorption disorders, such as persistent nausea/vomiting, intestinal obstruction, or short bowel syndrome, which may impair oral absorption of sialic acid; 8. Participation in another interventional clinical trial during screening, or receipt of any other anti-tumor therapy (e.g., chemotherapy, targeted therapy, small-molecule immunomodulators) within the past 4 weeks; 9. History of abuse of the study product, psychiatric disorders, or poor compliance, rendering the subject unable to adhere to the study protocol; 10. Any other condition deemed unsuitable for study participation by the investigator, such as potential major risks or pathological conditions not covered by the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, and types of treatment-related adverse events (TRAEs);Frequency of serious adverse events (SAEs), their association with the study product, and management measures;Dose-limiting toxicity;Maximum tolerated dose;Objective response rate;Disease control rate;Discontinuation rate, dose reduction rate, and withdrawal rate due to toxicity;Number of completed cycles of combination intervention, mean duration of intervention;Adherence to sialic acid administration and oral acceptability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Progression-free survival;Overall survival;Maximum concentration;Time to maximum concentration;Area under the curve;Half-life;Apparent clearance; | — |
Countries
China
Contacts
Public ContactShi Jieyi
Zhongshan Hospital, Fudan University
Outcome results
None listed