Advanced hepatocellular carcinoma
Conditions
Interventions
Entacapone-based Combination Therapy Group:Entacapone Tablets
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (inclusive), regardless of gender; 2. Patients positive for HBsAg should have received antiviral therapy according to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B: 2015 Update"; 3. Diagnosed with HCC confirmed by histopathology or imaging, meeting the diagnostic criteria of the AASLD or EASL; 4. HCC subjects with Barcelona Clinic Liver Cancer (BCLC) stage B/C or China Liver Cancer (CNLC) stage IIb and above as defined by the "Standardization for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)" ; 5. Have previously received standard therapy (e.g., Sintilimab + Apatinib, etc.) and experienced failure confirmed by imaging or clinical assessment; 6. Have at least one measurable lesion (according to RECIST v1.1 criteria). 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 8. Child-Pugh class A or class B with a score = 12 weeks; 10. Adequate organ function, defined as follows: (1) Adequate coagulation function: International Normalized Ratio (INR) = 50 mL/min; (5) Hemoglobin >= 90 g/L; (6) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (7) Absolute lymphocyte count >= 0.4 × 10^9/L; (8) Platelet count >= 80 × 10^9/L; (9) Albumin > 30 g/L; 11. Subjects of childbearing potential (male and female) must agree to use highly effective contraception methods with their partner during the trial and for 6 months after the last dose of the study drug, have no plan for conception, and agree not to donate sperm/oocytes; female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of the study drug; 12. Able to understand the study content, voluntarily sign the written informed consent form, and able to comply with the study treatment, follow-up, and sample collection.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with Entacapone or other COMT inhibitors; 2. History or presence of other uncured malignancies within the past 5 years, except for carcinoma in situ such as cervical cancer in situ or basal cell skin cancer that are considered clinically cured; 3. Central nervous system metastases or clinically significant central nervous system diseases; 4. Current presence of hepatic encephalopathy; 5. Current presence of moderate or severe pleural or peritoneal effusion; 6. History of severe infection after previous chemotherapy or significant delay in bone marrow hematopoietic recovery after chemotherapy (e.g., CTC AE >= Grade 3 myelosuppression lasting over 30 days) ; 7. Subjects with active autoimmune disease requiring immunosuppressive therapy including biologics (excluding topical use); or other significant persistent immune rejection based on pathological and clinical diagnosis; 8. Patients with a history of organ transplantation or currently awaiting organ transplantation (including liver transplantation) ; 9. Presence of severe coagulation disorders or other evidence of significant bleeding risk; 10. Hypertension judged by the investigator as poorly controlled (poorly controlled hypertension is defined as failure to maintain resting blood pressure consistently 8% after treatment); severe cardiac dysfunction (Left Ventricular Ejection Fraction (LVEF) < 45%); current cardiac disease requiring treatment, or myocardial infarction within the past 6 months, or unstable arrhythmia, or unstable angina, pulmonary embolism, cerebrovascular accident (including transient ischemic attack, history of stroke); chronic obstructive pulmonary disease, interstitial lung disease, and forced expiratory volume in 1 second (FEV1) < 60% of predicted value) ; 12. Past history of definite neurological or psychiatric disorders, including epilepsy or dementia; 13. Known positive HIV-1 test result or known history of AIDS; 14. Patients with positive Hepatitis C virus (HCV) antibody test result (unless Hepatitis C virus RNA PCR test result is negative or within the normal range, in which case enrollment is permitted) ; 15. Pregnant or lactating women, or those planning pregnancy in the near future; 16. Received anti-tumor therapy other than the original PD-1/L1 antibody and targeted agent maintenance therapy (e.g., TACE, HAIC, radiotherapy) within 4 weeks prior to screening; 17. Any other condition considered by the investigator as potentially affecting trial compliance, safety, or data interpretation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progress free survial;Overall survival;Safety and tolerance; | — |
Countries
China
Contacts
Public ContactQiang Gao
Zhongshan Hospital, Fudan University
Outcome results
None listed