hepatocellular carcinoma
Conditions
Interventions
Test group:Sindilimab+Bevacizumab
Sponsors
Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are eligible to participate in the trial 1) Diagnosed as hepatocellular carcinoma through histopathological examination; 2) During the screening period, intra-cancer CD8+ T cells in liver tumor biopsy specimens reach more than 5% 3) Meet the criteria for resectable surgery: a) Eastern Cooperative Oncology Group (ECOG) PS score 0; b) According to the "Standards for Diagnosis and Treatment of Primary Liver Cancer" (2022 Edition), operable stage IIb and IIIa patients with good liver reserve function (researchers need to strictly grasp the operable criteria) and stage Ia, Ib and IIa patients. Please see Appendix 3 for details of clinical staging of liver cancer; c) Child-Pugh Class A. Child-Pugh liver function classification is shown in Appendix 2; d) No main portal vein tumor thrombus or bile duct invasion; e) No invasion of adjacent organs, no hilar lymph nodes or distant metastasis. 4) Have at least one evaluable lesion according to RECIST1.1 criteria and have not received local treatment; 5) Patients with hepatocellular carcinoma who relapse after surgery, who relapse at least 6 months after surgery, meet the criteria for resectable surgery, and have at least one evaluable lesion according to RECIST 1.1 criteria, who have not received local treatment, can be enrolled. ; 6) Fully understand this study and voluntarily sign written informed consent; 7) Aged between 18 and 75 years old, regardless of gender; 8) The researcher believes that the patient has the ability to comply with the protocol; 9) Agree to provide fresh or previously stored lesion tissue, adjacent tissue and surgical specimens; relevant pathology reports of the above specimens must be provided; 10) Laboratory test values ??within 7 days before the start of neoadjuvant therapy must meet the following standards: a) Neutrophils =1.5 × 10^9/L; b) Platelets =75 × 10^9/L; c) Hemoglobin =90g/L (no concentrated red blood cells transfused within 2 weeks); d) Serum creatinine =1.5 × upper limit of normal (ULN) e) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 × ULN; f) Serum albumin =30 g/L; g) Patients not receiving anticoagulant therapy: INR or aPTT =1.5 × ULN. If the patient receives prophylactic anticoagulant therapy, INR =2 × ULN and aPTT within the normal range, they are accepted for enrollment; h) Serum bilirubin =1.25 × ULN 11) Within 21 days before enrollment, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the use of the study drug and within 60 days after the last dose of the study drug. Examples of contraceptive methods with an annual contraceptive failure rate of <1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper ring intrauterine devices. Or double barrier contraceptive measures, defined as condoms containing spermicide gel, foam, suppository, or film; or diaphragms containing spermicide and male condoms and diaphragms. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (e.g., calendar day, ovulation period, symptom temperature, or post-ovulation method) and withdrawal are unacceptable contraceptive methods. In this protocol, women of childbearing age are defined as sexually mat
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be allowed to enter this study: 1) Patients who have previously received anti-programmed death receptor-1 (PD-1) antibody, anti-programmed death ligand-1 (PD-L1) antibody, anti-programmed death ligand-2 (PD-L2) antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody, including patients who have participated in clinical studies of sintilimab; 2) Patients who have received any TACE, radiofrequency ablation or other local treatments for liver cancer and systemic anti-tumor treatments such as chemotherapy for liver recurrence; 3) Patients with a history of gastrointestinal bleeding within 6 months before randomization; patients with portal hypertension, patients who are considered by the researchers to have a high risk of bleeding (including moderate to severe esophageal varices with bleeding risk, local active gastrointestinal ulcers and persistent occult blood in the stool), need to undergo gastroscopy to exclude patients with "red signs". If the history of gastroscopy shows a "red sign", the patient shall be excluded from the group; 4) Patients with known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC; 5) Patients with active central nervous system (CNS) metastasis symptoms and/or carcinomatous meningitis, or patients with uncontrolled severe epilepsy, unless excluded by CT or MRI examination; 6) Patients with any active autoimmune disease or history of autoimmune disease (autoimmune hepatitis, interstitial pneumonia, uveitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis, etc., hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment): Patients with hypothyroidism but receiving stable doses of thyroid hormone replacement therapy are excluded; 7) Uncontrolled pleural effusion, pericardial effusion, or ascites of moderate or above volume; 8) Any history of renal disease or nephrotic syndrome; 9) Previous history of severe cardiovascular and cerebrovascular diseases: a) Congestive heart failure of New York Heart Association (NYHA) grade II or above, unstable angina, myocardial infarction or cerebrovascular accident stroke, or poorly controlled arrhythmia within 12 months before randomization; b) Left ventricular ejection fraction (LVEF) 480ms (calculated using Fridericia method, if QTc is abnormal, it can be tested three times with an interval of 2 minutes and the average value is taken); d) Hypertension that is difficult to control with 3 antihypertensive drugs (systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg); e) Previous hypertensive crisis or hypertensive encephalopathy. 10) Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia during screening of chest enhanced CT scans; except for patients with a history of radiation pneumonia (fibrosis) in the radiation area; 11) Patients who have undergone major surgery 2 weeks before enrollment and have not fully recovered from the previous surgery; 12) Patients with active bleeding or abnormal coagulation function (activated partial thromboplas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;; | — |
Countries
China
Contacts
Public ContactDing Zhenbin
Zhongshan Hospital
Outcome results
None listed