hepatocellular carcinoma, HCC
Conditions
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
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. Previously received at least 1L of standard PD-1 inhibitors (Camrelizumab, Sintilimab) treatment. 5. If previously receiving immunotherapy combined with anti vascular therapy, anti vascular targeted drugs are limited to TKI inhibitors (apatinib, lenvatinib, donafenib, sorafenib, etc.) 6. There must be at least one measurable lesion (based on the Recist v1.1 standard). 7. Child Pugh : A or B (= 7 points). 8. ECOG PS score: 0-1 points. 9. Expected survival time = 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 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 = 28g/L; Serum total bilirubin = 1.5 × ULN; ALT and AST = 3 × ULN; Blood creatinine = 1.5 × ULN or Cr clearance rate>50ml/min; (3) International normalized ratio (INR) = 2.3 or prothrombin time (PT) exceeding the normal control range = 6 seconds; (4) Urinary protein<2+(If urinary protein is = 2+, 24-hour (h) urine protein quantification must be performed, and 24-hour urine protein quantification<1.0g can be included in the group). 11. If suffering from hepatitis B virus (HBV) infection, it is necessary to be willing to receive antiviral treatment throughout the study period (according to the diagnostic and treatment guidelines, such as entecavir) and regularly monitor. 12. 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. Previously received PD-L1 inhibitors or bevacizumab treatment. 3. Subjects who are preparing for or have previously undergone organ or allogeneic bone marrow transplantation. 4. 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. 5. There is currently active autoimmune disease or a history of autoimmune disease 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]). 6. 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. 7. 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. 8. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) Grade II or above cardiac dysfunction according to the New York Heart Association (NYHA) standards (see Appendix 4) or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)480ms (QTc interval is calculated using Fridericia's formula; if QTc is abnormal, it can be detected three times in a row with a 2-minute interval, and the average value is taken). 9. Subjects with congenital or acquired immune dysfunction (such as HIV infected individuals). 10. Research on the occurrence of thrombotic or embolic events within 6 months prior to the start of treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. 11. If there is a history of gastrointestinal bleeding or a clear tendency towards gastrointestinal bleeding within 6 months before the start of treatment, such as severe esophageal and gastric varices with bleeding risk, locally active digestive ulcer lesions, and persistent positive fecal occult blood, they cannot be included in the study (if fecal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Progression free survival, PFS;Overall survival, OS;Duration of response, DoR; | — |
Countries
China
Contacts
Public ContactCong Ning
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed