Hepatocellular carcinoma
Conditions
Interventions
Experimental group:FOLFOX-HAIC combined with tislilizumab
Sponsors
Tianjin Third Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join this study and sign the informed consent form; 2. Age>=18 years old, male or female; 3. ECOG PS score 0-1; 4. Child-Pugh Liver Function Grade: Grade A 5. Primary hepatocellular carcinoma confirmed by pathological histology or cytology or meeting the clinical diagnostic criteria, and the lesion meets the indications for surgical resection in the Guidelines for the Diagnosis and Treatment of Primary Hepatocellular Carcinoma (2024 Edition); 6. Exceeding the "Milan standard"; 7. Have not received any topical or systemic treatment for HCC in the past; 8. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (measurable lesion CT/MRI scan long diameter >=10mm or lymph node lesion CT/MRI scan short diameter >=15mm, and the measurable lesion has not received radiotherapy, cryotherapy and other local treatments); 9. Estimated survival >= 6 months; 10. The function of vital organs meets the following requirements (within 7 days prior to initiation of study treatment): (1) Routine blood examination: (excluding hemoglobin, no blood transfusion within 14 days before screening, no use of granulocyte colony-stimulating factor [G-CSF], no drug correction): absolute neutrophil count>=1.5×10^9/L; Platelet >=75×10^9/L; hemoglobin > = 90 g/L; (2) Biochemical examination: (no albumin transfusion within 14 days before screening): serum albumin >=29g/L; Serum total bilirubin 50 mL/min (Cockcroft-Gault formula follows) Male: Cr clearance = ((140-age) × body weight) / (72× blood Cr) Female: Cr clearance = ((140-age)× body weight/(72× blood Cr) ×0.85 body weight unit: kg; Blood Cr unit: mg/mL; (3) International normalized ratio (INR) =2+, 24-hour (h) urine protein quantification can be performed, and 24-hour urine protein quantification <1.0g can be enrolled); 11. If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be < 500 IU/mL (or if the site only has a copy/mL testing unit.) <2500 copy/mL), and have received anti-HBV therapy (according to local standard therapy, such as entecavir) for at least 14 days prior to the start of study treatment and are willing to receive antiviral therapy throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA)-positive patients must be on antiviral therapy according to local standard treatment guidelines and have elevated liver function within CTCAE grade 1; 12. Females of childbearing potential should agree to use contraception (such as intrauterine device, contraceptive pill or condom) during the medication period and for 6 months after the end of the medication; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient, male subjects should agree to use contraception during the study and for 6 months after the end of the study period; 13. Subjects have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy, or other targeted therapy; 2. Known hepatobiliary cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; Patients with active malignant tumors other than HCC within 5 years or at the same time (cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc.) were eligible for inclusion. 3. Patients preparing for or previously receiving organ or allogeneic bone marrow transplantation; 4. Patients with previous PD-1/PD-L1 therapy were not eligible; The subject is known to have a previous allergy to macromolecular protein preparations, or to any of the excipients of tislelizumab; 5. The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood were included. Subjects with asthma requiring medical intervention with bronchodilators were excluded). 6. The subject is receiving immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppression (dose> 10mg/ day prednisone or other effective hormone), and continued to use within 2 weeks before enrollment; 7. Symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage; 8. Have poorly controlled cardiac clinical symptoms or diseases such as: (1) Heart failure above NYHA2 (2) unstable angina pectoris (3) history of myocardial infarction within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9. Patients with current (within 3 months) gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcer, ulcerative colitis, portal hypertension, or active bleeding in unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigators; 10. Previous or current severe bleeding (bleeding within 3 months; 30 ml), hemoptysis (within 4 weeks; 5 ml of fresh blood) or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 11. Subjects with active infection or unexplained fever during screening or before the first dose > 38.5 degrees (according to the investigator's judgment, the subject could be enrolled due to fever caused by tumor); 12. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, etc.; 13. Subjects with congenital or acquired immune deficiency, such as HIV infection or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA=104/ml; Hepatitis C reference: HCV RNA=103/ml); Chronic hepatitis B virus carriers, HBV DNA < 2000 IU/ml (< 104 copies /ml), and patients must receive antiviral therapy at the same time during the trial. 14. Live vaccine administered less than 4 weeks before or possibly during the study administration; 15. Received traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory eff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival, EFS;Time to Progression, TTP;Objective Response Rate, ORR;Disease-Free Survival, DFS;Safety; | — |
Countries
China
Contacts
Public ContactCheng Lou
Tianjin Third Central Hospital
Outcome results
None listed