Solid tumor
Conditions
Interventions
Experimental group:Adebrelimab-based therapy
Sponsors
Lianyungang First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. Age>= 18 years old, male or female; 3. Subjects with solid tumors confirmed by histology or cytology; 4. Subject has at least one measurable lesion according to RECIST 1.1 criteria; 5. Previously treated with PD-1 inhibitors, and disease progression or intolerance; 6. ECOG PS score: 0~1 points; 7. Expected survival time >= 3 months; 8. The laboratory test values within 14 days prior to enrollment meet the following requirements: 1) Routine blood examination: (except for hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], no correction with drugs) within 2 weeks before screening): absolute neutrophil count>=1.5×10^9/L; Platelet >=75×10^9/L; hemoglobin >=90 g/L; 2) Biochemical examination: serum albumin >=30g/L; serum total bilirubin 50 ml/min; 3) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 9. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, you need to test for HBV-DNA, and HBV-DNA needs to be =2000 IU/mL, at least 1 week of antiviral therapy prior to enrollment (only nucleoside drugs such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenol fumarate tablets are allowed) with a greater than 10-fold (1 lg) decrease in viral copy number compared to before treatment. For patients with HBV infection, antiviral therapy is required throughout the study. Hepatitis C virus (HCV)-RNA positive subjects must be on antiviral therapy as per treatment guidelines; 10. Women of childbearing potential must have a negative pregnancy test (ßHCG) before starting the first dose. Women of childbearing potential and men (sexually active with women of childbearing potential) must agree to contraception during treatment and within 6 months of the last dose; 11. The investigator determines that the patient can be treated with adebelimab.
Exclusion criteria
Exclusion criteria: 1. current concomitant interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis that may interfere with the determination and management of immune-related pulmonary toxicity, organic pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonitis, idiopathic pneumonitis, or active pneumonitis or severely impaired pulmonary function as demonstrated by chest CT at the Screening Period Subjects; active tuberculosis; 2. presence of active autoimmune disease or history of autoimmune disease with potential for relapse [including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects who can be controlled by hormone replacement therapy only are eligible for enrollment)]; subjects with skin disorders that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, and Controlled type I diabetes mellitus treated with insulin or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be enrolled; asthmatics requiring medical intervention with bronchodilators may not be enrolled; 3. immunosuppressive or systemic hormone therapy for immunosuppression (dose >10 mg/day prednisone or other equipotent hormone) within 2 weeks prior to enrollment; 4. Patients with active infections, unexplained fever =38.5°C within 1 week prior to enrollment, or baseline white blood cell count >15×109/L; therapeutic antibiotics given orally or intravenously within 2 weeks prior to enrollment (except for prophylactic antibiotics given intravenously with a duration of administration of no more than 48 hours); 5. Congenital or acquired immunodeficiency (e.g., HIV-infected); 6. Treatment with a live attenuated vaccine within 4 weeks prior to enrollment, or anticipation of needing such a vaccine during treatment or within 60 days of the last dose; 7. Known hereditary or acquired bleeding (e.g. coagulopathy) or thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, etc.; currently receiving full-dose oral or injectable anticoagulant or thrombolytic medications for therapeutic purposes (prophylactic use of low-dose aspirin, etc., is permitted); 8. have had an arterial thromboembolic event, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis of CTCAE grade 3 or higher, or pulmonary embolism in the 6 months prior to enrollment; 9. Have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) cardiac insufficiency of grade II or higher according to the New York Heart Association (NYHA) criteria or color Doppler echocardiography: LVEF (left ventricular ejection fraction) 450 ms (men); QTc > 470 ms (women); 10. significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to enrollment 11. Severe, unhealed or open wounds and active u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactYajun Ji
Lianyungang First People's Hospital
Outcome results
None listed