Hepatocellular carcinoma
Conditions
Interventions
Experimental group:adebrelimab combined with apatinib
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this study and sign the informed consent form. 2. Aged 18 or above, both male and female are welcome. 3. Subjects who have been diagnosed with HCC through histopathology/cytology or clinically diagnosed with HCC according to the "Diagnostic and Treatment Guidelines for Primary Liver Cancer (2022 Edition)". 4. Patients who have previously received at least one line (1L) of standard PD-1 inhibitor treatment, subsequently experienced tumor progression, and have a disease state that is either unresectable or unsuitable for surgical treatment. 5. If the patient continues to receive the immunotherapy combined with targeted therapy regimen, the targeted drugs should be limited to TKI drugs (such as apatinib, lenvatinib, dorafenib, sorafenib, etc.). 6. There must be at least one measurable lesion (based on the RECIST v1.1 criteria). 7. Child-Pugh liver function classification: Class A or Class B (= 12 weeks. 10. The main organ functions meet the following requirements (within 7 days before enrollment): (1) Blood routine examination: (excluding hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], and no drug correction within 14 days before screening): • Absolute neutrophil count >=1.5×10^9/L; • Platelets >=75×10^9/L; • Hemoglobin >=90g/L. (Patients with leukopenia and thrombocytopenia caused by hypersplenism can be enrolled after partial splenic artery embolization or pharmacological correction) (2) Blood biochemical examination (no albumin transfusion within 14 days before screening): • Serum albumin >=28g/L; • Total serum bilirubin 50ml/min (Cockcroft-Gault formula is as follows): Male: creatinine clearance rate = ((140-age) × weight) / (72 × serum creatinine) Female: creatinine clearance rate = ((140-age) × weight) / (72 × serum creatinine) × 0.85 Weight unit: kg; serum creatinine unit: mg/ml; (3) International normalized ratio (INR) =2+, a 24-hour urine protein quantitation is required; if the 24-hour urine protein quantitation is <1.0g, the patient can be enrolled). 11. If infected with Hepatitis B Virus (HBV), participants must be willing to undergo antiviral treatment (administered according to diagnostic and treatment guidelines, such as entecavir) throughout the study period and undergo regular monitoring. 12.Female subjects with reproductive capacity: They must agree to use contraception from the time of signing the informed consent form until 90 days after the last administration of the study drug (whichever is longer). Additionally, their blood HCG test must be negative within 7 days prior to the commencement of study treatment; and they must not be lactating.
Exclusion criteria
Exclusion criteria: 1. Known types of liver cancer include cholangiocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular and cholangiocellular carcinoma, and fibrolamellar hepatocellular carcinoma; patients with other active malignancies (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) other than hepatocellular carcinoma within 5 years or concurrently. 2. Previously treated with PD-L1 inhibitors or bevacizumab. 3.Subjects who are preparing for or have previously undergone organ or allogeneic bone marrow transplantation. 4. 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 have other pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or other conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, or who show evidence of active pneumonia or severe impairment of lung function on chest computed tomography (CT) scans during the screening period, are allowed to have a history of radiation pneumonia in the radiation field; active tuberculosis. 5. Currently, there are subjects with active autoimmune diseases or a history of autoimmune diseases that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who can be controlled only by hormone replacement therapy can be included]). 6. Patients with hypertension who cannot 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) are allowed to achieve the above parameters through the use of antihypertensive treatment; patients who have previously experienced hypertensive crisis or hypertensive encephalopathy. 7. Patients with moderate or severe ascites exhibiting clinical symptoms, who require therapeutic puncture and drainage, or those with a Child-Pugh score >2 (excluding those with only a small amount of ascites shown by imaging but without accompanying clinical symptoms); patients with uncontrolled or moderate to severe pleural effusion or pericardial effusion. 8. Having uncontrolled cardiac clinical symptoms or diseases, such as: (1) cardiac dysfunction above Class II according to the New York Heart Association (NYHA) criteria (see Annex 4) or left ventricular ejection fraction (LVEF) 480ms (QTc interval is calculated using the Fridericia formula; if QTc is abnormal, it can be measured three times at 2-minute intervals and the average taken). 9. Subjects with congenital or acquired immune deficiency (such as HIV-infected individuals). 10. Thrombosis or embolic events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., have occurred within 6 months prior to the commencement of study treatment. 11. Patients with a history of gastrointestinal bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-Free Survival;Duration of Response;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactWang Tao
Yantai Yuhuangding Hospital
Outcome results
None listed