hepatocellular carcinoma
Conditions
Interventions
Test group:lenvatinib+ sintilimab+ XELOX systemic chemotherapy regimen
Sponsors
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old; 2. Histological or cytological or clinical diagnosis of Hepatocellular Carcinoma (HCC) and clinical stage C BCLC before treatment; 3. Liver function Child-Pugh score = 10 mm or lymph node lesion with a short CT scan diameter >= 15 mm, and the measurable lesion has not received local treatment such as radiotherapy or cryotherapy); 6. ECOG PS score = 12 weeks; 8. Major organ function meets the following requirements (within 7 days prior to initiation of study treatment): Bone marrow function: white blood cells (WBC) >=3.0*109/L, platelets (PLT) >=70*109/L, haemoglobin >=80g/L (no transfusion within 14 days); renal function: blood Cr <=1.5 ULN; hepatic function: total bilirubin (TBIL) <=1.5 × ULN (upper limit of normal), glutathione (ALT) and glutamic acid transaminase (GAT) <=1.5 × ULN; and liver function: total bilirubin (TBIL) <=1.5 × ULN. Liver function: total bilirubin (TBIL) <=1.5 × ULN (upper limit of normal), alanine aminotransferase (ALT) and azelaic aminotransferase (AST) <=3 × ULN; 9. Patients with comorbid hepatitis B or C require antiviral medication and are not using interferon; 10. women of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to study entry and must be non-lactating and agree to use contraception during the study period and for 6 months after the end of the study; men should agree that they must use contraception during the study period and for 6 months after the end of the study period; 11. voluntarily enrol in the project and sign an informed consent form before the start of the study, and have good compliance during treatment.
Exclusion criteria
Exclusion criteria: 1. Previous use of immunotherapy-related drugs or interferon; 2. Allergy to any drug in the treatment regimen; 3. Pregnancy or lactation in females; 4. Prior administration of other immunotherapy drugs (targeting PD-1/PD-L1); 5. Uncontrolled cardiac clinical symptoms or conditions, such as: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; (5) uncontrolled hypertension despite medication, where the physician assesses apatinib use as posing a high risk; 6. Known hepatobiliary duct cell carcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma; active malignancies other than HCC within the past 5 years or concurrently present. Patients with cured, localised tumours such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma in situ of the prostate, carcinoma in situ of the cervix, or carcinoma in situ of the breast may be included; 7. Concurrent severe infection (CTCAE = Grade 2) prior to treatment initiation, such as hospitalisation-requiring severe pneumonia, active pulmonary tuberculosis, bacteraemia, or infection-related complications; baseline chest imaging indicating active pulmonary inflammation; presence of infection symptoms/signs within 2 weeks before first study drug administration; or requiring oral/intravenous antibiotic therapy (excluding prophylactic antibiotic use); 8. History of immunodeficiency, such as HIV monitoring positive status, other acquired or congenital immunodeficiency disorders (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes), or history of organ or bone marrow transplantation; or currently receiving oral or intravenous corticosteroids or other immunosuppressive agents; excluding vitiligo or childhood asthma/allergies that have resolved without requiring any intervention in adulthood; 9. Severe coagulation disorders (INR > 2.0, PT > 16 seconds) with significant bleeding tendency (including but not limited to daily haematemesis or melena within the past 3 months); 10. Moderate to severe clinical ascites requiring therapeutic paracentesis or drainage, or Child-Pugh score >2 (excluding cases with imaging-detected minimal ascites without clinical symptoms); uncontrolled or moderate-to-large pleural effusion or pericardial effusion; 11. History of gastrointestinal bleeding within 6 months prior to study treatment initiation, or confirmed risk of gastrointestinal bleeding, such as: high-risk or severe oesophageal/gastric varices, active localised peptic ulceration, persistent positive faecal occult blood test – ineligible for enrolment; 12. Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to study treatment initiation; 13. Thrombotic or embolic events within 6 months prior to study treatment initiation, e.g., cerebrovascular accident (including transient ischaemic attack, cerebral haemorrhage, cerebral infarction), pulmonary embolism; 14. Major vascular disease within 6 months prior to study treatment initiation (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis); severe, unhealed or ruptured wounds; active ulcers; or untreated fractures; 15. Pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical conversion rate;Overall survival period;Progression free survival period;Recurrence free survival period; | — |
Countries
China
Contacts
Public ContactHeyun Zhang
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed