hepatocellular carcinoma
Conditions
Interventions
Group 1:Oxaliplatin 85 mg/m^2, formyltetrahydrofolic acid 400 mg/m^2, fluorouracil 400 mg/m^2, followed by a continuous infusion of fluorouracil 2400 mg/m^2 every 3 weeks for 46 hours, a total of 2 cy
Group 2:Lenvatinib (12 or 8mg/kg, po, qd) in combination with Sindillizumab (200mg, iv, d1, q3w)
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study and signed informed consent; 2. No gender limit, aged 18-75 years; 3. ECOG PS score 0-1; 4. Child-Pugh liver function classification: Grade A; 5. Primary hepatocellular carcinoma was confirmed by histology and the lesion was in accordance with the indications of operable resection in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition); 6. As previously assessed by the investigators, there are the following high risk factors for recurrence: Stage I b: single tumor with maximum diameter > 5cm; 7. According to RECIST 1.1 standards, the patient had at least one measurable lesion (the CT/MRI scan diameter of the lesion could be measured at >=10mm or the CT/MRI scan diameter of the lymph node lesion could be measured at >=15mm, and the lesion could be measured at no local treatment such as radiotherapy or freezing); 8. Expected survival >= 6 months; 9. The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : (1) Blood routine: neutrophil >=1,500/mm^3, platelet count >=60,000/mm^3, hemoglobin >=5.6 mmol/L (9g/dL); (2) Liver and kidney function: serum creatinine (SCr) =50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) =2+, the 24-hour urinary protein quantitation must show protein <=1g; 10. Normal coagulation function, no active bleeding and thrombosis diseases: (1) INR<=1.5xULN; (2) Partial thrombin time APTT<=1.5xULN; (3) Prothrombin time PT<=1.5ULN; 11. Patients of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the duration of medication and for six months after termination of medication; Patients who had a negative serum or urine pregnancy test within 7 days prior to study enrollment, who were non-lactating patients and who had male consent to use contraception during the study period and for 6 months after the study period ended; 12. Patients have good compliance and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Previously received radiotherapy, chemotherapy, concurrent radiotherapy and chemotherapy or other targeted therapies; 2. Known hepatobiliary cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; Have other active malignant tumors except HCC within 5 years or at the same time; 3. Patients with hypertension who cannot be well controlled after antihypertensive drug treatment (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); Previous hypertension crisis or hypertensive encephalopathy; 4. Patients had other malignant tumors in the past or at the same time (except cured skin basal cell carcinoma and cervical carcinoma in situ); 5. Patients who had been treated with sitilimab or other PD-1/PD-L1 inhibitors in the past could not be included; Known hypersensitivity to macromolecular protein preparations or any excipients of sitilimab or lenvatinib; 6. Patients have any active autoimmune diseases or have a history of autoimmune diseases (Including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or asthma in childhood has completely alleviated, without any intervention after adulthood can be included; Patients with asthma requiring medical intervention of bronchodilators cannot be included); 7. Patients who are using immunosuppressive agents, or systemic or absorbable local hormone to achieve immunosuppressive purpose (Dose>10mg/day prednisone or other equivalent therapeutic hormones) and continue to use them within 2 weeks before enrollment; 8. Ascites or pleural effusion with clinical symptoms and requiring therapeutic puncture or drainage; 9. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 10. Patients having gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from tumors that have not been removed, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator at present (within 3 months); 11. Previous or current severe bleeding (bleeding >30 mL within 3 months), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months; 12. Patients with active infection or fever of unknown origin>38.5?during the screening period and before the first administration (according to the judgment of the investigator, subjects with fever due to tumor can be included); 13. Patients with past or current objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of pulmonary function; 14. Patients with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase did not meet inclusion criteria, hepatitis B reference: HBV DNA>=10^4/mL; Hepatitis C reference: HCV RNA>=10^3/mL); Chronic hepatitis B virus carriers with HBV DNA < 2000 IU/mL (<10^4 copies /mL) must also receive antiviral therapy during the trial to be enrolled; 15. Live
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of microvascular invasion;Pathological complete response rate;Objective response rate;2-year disease-free survival rate;2-year overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactCui Yunlong
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed