hepatocellular carcinoma
Conditions
Interventions
Group A:sintilimab+bevacizumab
Group C:Chidamide+sintilimab+bevacizumab+capecitabine
Group B:Chidamide+sintilimab+bevacizumab
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in the trial, give full informed consent, sign a written informed consent form, and have good compliance; 2. Age >=18 years old, male and female; 3. Hepatocellular carcinoma confirmed by histopathological or cytological or clinical diagnosis (according to the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)"); 4. Barcelona clinical liver cancer stage (BCLC stage) is stage C, or stage B that is not suitable for radical surgery or local treatment; 5. No previous systemic anti-tumor therapy for hepatocellular carcinoma (including but not limited to molecular targeted therapy, systemic chemotherapy, immunotherapy such as PD-1/PD-L1/CTLA-4 monoclonal antibodies, etc.); 6. Child-Pugh liver function grade A or B (=12 weeks; 10. Organs and bone marrow with adequate function to meet the following requirements (within 14 days prior to initiation of study treatment): (1) Blood routine examination: (no blood transfusion within 14 days before screening, no granulocyte colony-stimulating factor [G-CSF], no drug correction): hemoglobin [HB] >=90g/L; Neutrophil absolute count [ANC] >=1.5×10^9/L; Platelets [PLT] >=75×10^9/L; (2) Blood biochemistry examination must meet the following criteria (no albumin transfusion 14 days before screening): serum total bilirubin [BIL] =50ml/min (Cockcroft-Gault formula) Male: Cr clearance = ((140-age) ×weight)/(72×blood Cr) Female: Cr clearance = ((140-age) × body weight)/(72×blood Cr) × 0.85 (weight unit: kg; Blood Cr unit: mg/mL); (3) Coagulation function: international normalized ratio (INR) =10 IU/mL or above the limit of detection]) must be treated with antiviral therapy after inclusion (signing the ICF) according to institutional standards of practice to ensure adequate viral suppression (HBV DNA=10 IU/mL or above the limit of detection according to local local laboratory standards). Patients with detectable HBV DNA during the study must be initiated and maintained on antiviral therapy during the study and within 6 months after the last dose of study treatment; 12. Female subjects of childbearing potential must have a urine or serum pregnancy
Exclusion criteria
Exclusion criteria: 1.Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, intrahepatic cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma, etc. 2.History of other malignancies within 5 years prior to enrollment, except for hepatocellular carcinoma. 3.History of leptomeningeal disease, brain metastases, or current brain metastases. 4.Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage (excluding cases with only radiologically detected minimal ascites without clinical symptoms), or uncontrolled or moderate to large pleural effusion or pericardial effusion. 5.Participation in another clinical study involving an investigational product within the past 3 months, or concurrent enrollment in another clinical study, unless it is an observational, non-interventional study or the follow-up phase of an interventional study. 6.Any evidence of disease (e.g., severe or uncontrolled systemic diseases, including uncontrolled hypertension, active hemorrhagic disorders, active infections, active ILD/interstitial lung disease, severe chronic gastrointestinal disorders associated with diarrhea, psychiatric illness/social situations) as determined by the investigator, or history of allogeneic organ transplantation that, in the investigator’s judgment, makes the subject unsuitable for participation in the study or may affect protocol compliance. 7.History of severe cardiovascular or cerebrovascular diseases within 12 months prior to randomization: congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina, myocardial infarction, poorly controlled arrhythmias, or cerebrovascular accident; left ventricular ejection fraction (LVEF) 480 ms (calculated using Fridericia’s method; if QTc is abnormal, it may be measured three times consecutively at 2-minute intervals and averaged). 8.Active autoimmune disease within the past 2 years, or history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [patients controlled only with hormone replacement therapy are not excluded]). 9.Prior immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (e.g., CD40, CD137, OX40 antibodies, etc.), immune cell therapy, or any treatment targeting tumor immune mechanisms, except for therapeutic anticancer vaccines. 10.Co-infection with HBV (HBsAg and/or anti-HBcAb positive with detectable HBV DNA per local laboratory standards) and HCV (anti-HCV antibody positive), or co-infection with HBV and HDV (anti-HDV antibody positive). 11.History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first study dose, severe varices identified by endoscopy within 3 months prior to the first study dose, or evidence of portal hypertension (including splenomegaly on imaging) with a high risk of bleeding as assessed by the investigator (including moderate to severe esophageal or gastric varices with bleeding risk, locally active peptic ulcer, and persistent fecal occult blood positivity). Gastroscopy is required to exclude patients with "red color signs." Patie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;overall survival;disease control rate;duration of response;progression-free survival;time to response; | — |
Countries
China
Contacts
Public ContactLi Wei
The First Affiliated Hospital of Soochow University
Outcome results
None listed