Hepatocellular carcinoma with high risk of recurrence after resection surgery
Conditions
Interventions
Treatment group:Adebrelimab combined with Apatinib as adjuvant therapy after surgery
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign an informed consent form. 2. Age >= 18 years old, both male and female are eligible. 3. Subjects diagnosed with HCC through histopathology/cytology or clinically diagnosed with HCC according to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition)". 4. Radical resection was performed within 4-12 weeks prior to enrollment. 5. Complete recovery from surgical resection within 4 weeks prior to enrollment. 6. High risk factors for recurrence of hepatocellular carcinoma after resection surgery (multiple tumors, tumor length>5cm, poor tumor differentiation (Edmondson III-IV grade), resection margin = 12 weeks. 11. The main organ functions meet the following requirements (within 7 days before enrollment): (1) Blood routine examination: (excluding hemoglobin, no blood transfusion within 14 days before screening, no use of granulocyte colony-stimulating factor [G-CSF], no medication correction): Absolute neutrophil count >= 1.5 × 10 ^ 9/L; Platelets >= 75 × 10 ^ 9/L; Hemoglobin >= 90g/L. (Leukopenia and thrombocytopenia caused by splenic hyperfunction can be included in the study after partial splenic artery embolization or drug correction.) (2) Blood biochemistry test (no albumin transfusion within 14 days before screening): Serum albumin 50ml/min (3) International normalized ratio (INR) = 2+, 24-hour (h) urine protein quantification must be performed, and 24-hour urine protein quantification<1.0g can be included in the group). 12. If suffering from hepatitis B virus (HBV) infection, one must be willing to receive antiviral treatment throughout the study period (according to diagnostic and treatment guidelines, such as entecavir) and regularly monitor; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive antiviral treatment according to diagnostic and treatment guidelines and have liver function within CTCAE1 level elevation. 13.Women with fertility must agree to contraception from the time of signing the informed consent form until 90 days (whichever is longer) after the last use of the study drug. And the blood HCG test must be negative within 7 days before starting the study treatment; And it must be non lactating.
Exclusion criteria
Exclusion criteria: 1. Known hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatic mixed cell carcinoma, and fibrolamellar cell carcinoma; Within 5 years or simultaneously with other active malignant tumors other than hepatocellular carcinoma (excluding cured skin basal cell carcinoma and cervical carcinoma in situ). 2. There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS). 3. Previously received local treatments, including therapeutic TACE, transarterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE), etc. 4. Subjects who are preparing for or have previously undergone organ or allogeneic bone marrow transplantation. 5. For subjects who currently have interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or have evidence of active pneumonia or severe lung function impairment on chest computed tomography (CT) images during screening, radiation pneumonitis in the radiation field is allowed; Active tuberculosis. 6. Currently present with active autoimmune diseases or a history of autoimmune diseases that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can only be controlled through hormone replacement therapy may be included]); Subjects with skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma subjects who require bronchodilators for medical intervention cannot be included. 7. Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg) (based on the average of BP readings obtained from >= 2 measurements), it is allowed to achieve the above parameters through antihypertensive treatment; Previously experienced hypertensive crisis or hypertensive encephalopathy. 8.Moderate or severe ascites with clinical symptoms that require therapeutic puncture, drainage, or a Child Pugh score>2 (excluding those with only a small amount of ascites on imaging but no clinical symptoms); Uncontrolled or moderate to severe pleural and pericardial effusion. 9. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) heart dysfunction of grade II or above according to the New York Heart Association (NYHA) standards or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)480ms (QTc interval calculated using Fridericia's formula; If QTc is abnormal, it can be detected three times in a row with an interval of 2 minutes, and the average value should be taken. 10. History of spontaneous rupture of liver tumors. 11. Individuals with a history of hepatic encephalopathy. 12. S
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse-free survival, RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Time to recurrence, TTR;12Y-RFS%;24Y-RFS%;12Y-OS%;24Y-OS%;Drug safety; | — |
Countries
China
Contacts
Public ContactLi Tao
Qilu Hospital of Shandong University
Outcome results
None listed