hepatocellular carcinoma
Conditions
Interventions
Test group:Hepatic Arterial Infusion Chemotherapy (HAIC) Combined with Bevacizumab and PD-1 Monoclonal Antibody, Followed by Chidamide.
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joins this study and signs the informed consent form. 2. Aged >=18 years and =12 weeks. 10. Functions of vital organs meet the following requirements (no blood components, growth factors, or corrective therapies allowed within 14 days prior to initial treatment): • Absolute neutrophil count >=3.0×10^9/L; • Platelets >=80×10^9/L; • Hemoglobin >=90 g/L; • Serum albumin >=28 g/L; • Thyroid-stimulating hormone (TSH) <= 1×ULN (if abnormal, FT3 and FT4 levels should be evaluated simultaneously; if FT3 and FT4 are normal, the patient may be enrolled); • Bilirubin <=1.5×ULN (within 7 days before initial treatment); • ALT and AST <=3×ULN (within 7 days before initial treatment); • ALP <=2.5×ULN; serum creatinine <=1.5×ULN. 11.For non-surgically sterile or fertile female patients, a medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study treatment and for 3 months after treatment completion. Non-surgically sterile fertile female patients must have a negative serum or urine HCG test within 72 hours before study enrollment and must not be breastfeeding. Male patients with partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Histologically/cytologically confirmed components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma. 2. Presence of any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators is excluded). 3. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (dose >10mg/day prednisone or equivalent) within 2 weeks prior to enrollment. 4. Known allergy to any component of the study drug(s); or history of severe allergic reaction to other monoclonal antibodies. 5. Known history of hepatic encephalopathy or organ transplantation. 6. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg). 7. Poorly controlled cardiac clinical symptoms or diseases, such as: (1) heart failure of NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc > 450 ms (male) or QTc > 470 ms (female). 8. Abnormal coagulation (INR >2.0, PT >16 s), hemorrhagic tendency, or undergoing thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin or low molecular weight heparin is allowed). 9. Clinically significant bleeding symptoms or definite hemorrhagic tendency within 3 months prior to enrollment, such as hemoptysis/expectoration of blood >=2.5 mL, gastrointestinal bleeding, esophageal/gastric varices with bleeding risk, hemorrhagic gastric ulcer, or vasculitis, etc. 10. Severe gastroesophageal varices confirmed by endoscopy, or portal hypertension with evidence of high bleeding risk. 11. Arterial/venous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc. 12. Known hereditary or acquired bleeding and thrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, etc.). 13. Urinalysis showing urine protein >=++ and confirmed 24-hour urinary protein >1.0 g. 14. Active infection, unexplained fever >=38.5°C within 7 days prior to medication, or baseline white blood cell count >15×10^9/L. 15. Congenital or acquired immunodeficiency (e.g., HIV infection). 16. HBV-DNA >2000 IU/mL (or 10^4 copies/mL); or HCV-RNA >10^3 copies/mL; or HBsAg positive and anti-HCV antibody positive. 17. History or concurrent diagnosis of other malignancies within the past 3 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 18. Symptomatic ascites requiring paracentesis or drainage, or history of ascites drainage within the past 3 months (patients with only imaging showing a small amount of ascites without clinical symptoms are excluded from this criterion). 19. Prior treatment with other anti-PD-1 antibodies, other immunotherapy targeting PD-1/PD-L1, or other immunotherapy. Prior treatment with targeted therapies against VEGF and/or VEGFR, RAF, MEK, PDGFR, FGFR, and other signaling pathways
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Objective Response Rate (ORR);Disease Control Rate (DCR);Duration of Response (DOR); | — |
Countries
China
Contacts
Public ContactZilin Huang, Wang Li
Sun Yat-Sen University Cancer Center
Outcome results
None listed