Hepatocellular carcinoma
Conditions
Interventions
Experimental group:TACE or HAIC in combination with Sintilimab and Ramucirumab
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form before any trial-related procedures. 2. Age between 18 and 70 years. 3. ECOG PS score of 0-1. 4. Initially diagnosed with hepatocellular carcinoma according to the Chinese Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 edition). 5. Barcelona Clinic Liver Cancer (BCLC) stage B or C. 6. No prior systemic anti-tumor therapy for hepatocellular carcinoma. 7. Child-Pugh score of A. 8. Expected survival time of more than 3 months. 9. At least one measurable lesion according to RECIST v1.1/mRECIST criteria. 10. Total triiodothyronine (T3) or free T3 and free thyroxine (T4) within normal ranges (controlled by thyroid replacement therapy if necessary). Asymptomatic patients with abnormal T3, free T3, or free T4 may be included. 11. Well-controlled blood pressure. 12. Adequate organ and bone marrow function with laboratory values within the following criteria within 7 days before enrollment (no administration of blood components, cell growth factors, albumin, or other corrective treatments within 14 days before laboratory tests): 1. Hematology: Absolute neutrophil count (ANC) =1.5×10^9/L; Platelet count (PLT) =75×10^9/L; Hemoglobin (HGB) =9.0 g/dL. 2. Liver function: Serum total bilirubin (TBIL) =3×upper limit of normal (ULN); Alanine aminotransferase (ALT), aspartate transferase (AST), and alkaline phosphatase (ALP) =5×ULN; Serum albumin =28 g/L. 3. Kidney function: Serum creatinine (Cr) =1.5×ULN or creatinine clearance (CCr) =50 mL/min (Cockcroft-Gault formula); Urinalysis shows proteinuria <2+; For patients with baseline proteinuria =2+, a 24-hour urine collection must show <1 g of protein. 4. Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) =1.5×ULN. 13. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose of study medication (Day 1 of Cycle 1). If the urine test result is not confirmatory, a blood pregnancy test is required. Women not of childbearing potential are defined as postmenopausal for at least one year or having undergone surgical sterilization or hysterectomy. 14. All participants (both male and female) with reproductive potential must use highly effective contraception (annual failure rate <1%) throughout the treatment period and for 120 days after the last dose of study medication (or 180 days after the last dose of chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed by histology/cytology with hepatocellular carcinoma containing fibrolamellar, sarcomatoid, or cholangiocarcinoma components. 2. History of hepatic encephalopathy or liver transplantation. 3. Clinically significant pleural effusion, ascites, or pericardial effusion requiring drainage. 4. Central nervous system metastasis. 5. History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months. Severe (G3) varices observed on endoscopy within 3 months before the first dose. High bleeding risk due to portal hypertension (including splenomegaly on imaging) as assessed by the investigator. 6. Life-threatening bleeding events within the past 3 months, including those requiring transfusion therapy, surgery, local treatment, or ongoing medication. 7. Arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other severe thromboembolic conditions. Excludes catheter-associated thrombosis or superficial vein thrombosis stabilized by conventional anticoagulation. Prophylactic use of low-dose low molecular weight heparin (e.g., enoxaparin 40 mg/day) is permitted. 8. Continuous use of aspirin (>325 mg/day) or other platelet function inhibitors like dipyridamole or clopidogrel within 2 weeks before the first dose. 9. Uncontrolled hypertension, with systolic BP >150 mmHg or diastolic BP >90 mmHg after optimal medical therapy, or a history of hypertensive crisis or hypertensive encephalopathy. 10. Symptomatic congestive heart failure (NYHA Class II-IV). Symptomatic or poorly controlled arrhythmias. History of congenital long QT syndrome or corrected QTc >500ms (using Fridericia’s formula) at screening. 11. Severe bleeding tendency or coagulation disorder, or currently receiving thrombolytic therapy. 12. History of gastrointestinal perforation and/or fistula, intestinal obstruction requiring parenteral nutrition, extensive bowel resection (partial colectomy or extensive small intestine resection with chronic diarrhea), Crohn’s disease, ulcerative colitis, or chronic diarrhea within the past 6 months. 13. Radiotherapy within 3 weeks before the first dose. For patients receiving radiotherapy more than 3 weeks before the first dose, all related toxicities must have resolved, they must not require corticosteroids, and radiation-related pneumonitis, hepatitis, or enteritis must be excluded. 14. History of or current pulmonary fibrosis, interstitial lung disease, pneumoconiosis, drug-induced pneumonitis, or severely impaired lung function. 15. Active pulmonary tuberculosis (TB), currently undergoing anti-TB treatment or having received anti-TB treatment within the past year. 16. HIV infection (positive HIV 1/2 antibodies), known syphilis infection. 17. Severe infection that is active or poorly controlled, including severe infections requiring hospitalization for bacteremia or severe pneumonia complications within 4 weeks before the first dose. 18. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are allowed. Known history of primary immunodeficiency. Patients with only positive autoimmune antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Surgical conversion rate;Major pathological response rate (MPR);Safety;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Haibin
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed