Hepatocellular carcinoma
Conditions
Interventions
one:Preoperative adjuvant medication
Sponsors
MENCHAO HEPATOBILIARY HOSPITAL OF FUJIAN MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1). Age :=18 years old, male or female; 2) For patients with hepatocellular carcinoma diagnosed pathologically or clinically, the clinical diagnostic criteria are in line with the Diagnosis and Treatment Guidelines for HCC (2022 edition); 3) Hepatocellular carcinoma patients who can be surgically resected at the first visit but exceed the up-to-seven criteria have no macrovascular invasion and extrahepatic metastasis, and have not received other systemic and local antitumor therapy after diagnosis; 4). child-Pugh score: Grade A; 6). ECOG score 0-1 in the week before enrollment; 7). At least one CT or MRI measurable lesion meets mRECIST and RECIST 1.1 criteria; 8). Expected survival time =3 months; 9) The laboratory test values within 1 week before randomization meet the following requirements: (1) Routine blood examination: (excluding hemoglobin, no blood transfusion within 2 weeks prior to screening, no granulocyte colony stimulating factor [G-CSF], no drug correction) : ? neutrophil count absolutely acuity 1.5 x 109 / L; ? platelet 50 x 109 / L or higher; ? hemoglobin or 90 g/L; (2) and biochemical examination: ? ? serum albumin acuity 30 g/L ? serum total bilirubin acuities were 3 x ULN. ? ALT and AST 5 x ULN or less; ? serum creatinine 1.5 x ULN or less; Or Cr clearance rate > 50 ml/min (The Cockcroft-Gault formula is as follows) : Male: Cr clearance = ((140- age) × body weight)/(72× blood Cr) Female: Cr clearance = ((140- age) × body weight)/(72× blood Cr) ×0.85 Weight unit: kg; Blood Cr unit: mg/ml; (3) International Standardized ratio (INR) =1.5 or prothrombin time (PT) exceeding normal control range =6 seconds; (4) urinary protein < 2+ (If urine protein =2+, 24 hours (h) urine protein quantification, 24 hours (h) urine protein quantification<1.0g can be included) 10). Patients with active hepatitis B virus (HBV) infection: HBV-DNA<2000IU/ml(It must be 104Copy/ml if the research center only has copy /ml test units; ) and received antiviral therapy before and during treatment; Hepatitis C virus (HCV) RNA positive patients: hcV-RNA < 103/ml, antiviral therapy must be performed in accordance with standard local treatment guidelines; 11) Fertile women: must agree to abstain from sex (abstaining from heterosexual intercourse) or use a reliable, effective method of contraception from the time of signing the informed consent until at least 120 days after the final administration of the study drug. Serum HCG test must be negative within 1 week before randomization; A woman is considered fertile if she has menstruated, has not reached postmenopausal status (no continuous menstruation for =12 months and no cause other than menopause has been found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) 12). Male subjects whose partner is a fertile woman must agree to abstain from sex or to use a reliable, effective method of contraception for at least 120 days from the date of signing the informed consent until the final administration of the study drug. Male subjects also had to agree not to donate sperm during the same time period. Male subjects whose partners are already pregnant are required to use condoms and do not need to use other methods of contraception. 13) The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with contraindications to immunotherapy, including but not limited to the following: patients after transplantation, patients with severe autoimmune diseases, patients with organ failure, patients with grade 4 or above adverse reactions after previous use of immunotherapy, and patients with uncontrollable infectious diseases; 3. Immunosuppressive drugs or systemic hormone therapy were used within 14 days prior to enrollment for immunosuppressive purposes (dose > 10mg/ day prednisone or other therapeutic hormone); 4. Patients with confirmed allergy to carrilizumab injection, Ronvatinib tablets and its excipients or to other monoclonal antibodies; 5. The patient has consciousness disorder or cannot cooperate with treatment, and has mental illness; 6. Patients who have participated in other clinical trials in the past three months; 7. Severe liver, kidney, heart, lung, brain and other major organ failure; 8. Patients with other concomitant diseases that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 rate;relapse-free survival, RFS;Safety and tolerability of combination therapy;Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological remission, MPR;objective response rate, ORR; | — |
Countries
CHINA
Contacts
Public Contactzengyongyi
MENCHAO HEPATOBILIARY HOSPITAL OF FUJIAN MEDICAL UNIVERSITY
Outcome results
None listed