Solid tumors
Conditions
Interventions
Sponsors
Affiliated Hospital of Jiangnan University
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, TNM stage IIIb/IV; 4. Subject has at least one measurable lesion according to RECIST 1.1 criteria; 5. Non-PD subjects who have developed irAE during previous ICS treatment, except for the following: Grade =3 skin toxicity/pancreatitis/pneumonia/proteinuria/myasthenia gravis; > = grade 2 myocarditis/encephalitis; 6. Remission of irAEs to = 3 months; 10. The laboratory test values within 14 days prior to enrollment meet the following requirements: a) 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; b) Biochemical examination: serum albumin >=30g/L; serum total bilirubin 50 ml/min; c) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 11. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, you need to test for HBV-DNA, and the 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; 12. Women of childbearing potential must have a negative pregnancy test (ß-HCG) 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; 13. The investigator judged that the patient could be treated with adebelimab.
Exclusion criteria
Exclusion criteria: 1. Use of immunosuppressants or systemic hormone therapy within 2 weeks prior to enrollment to achieve immunosuppressive purposes (dose> 10mg/day prednisone or other efficacy hormones); 2. The patient has active infection, unexplained fever =38.5°C, or baseline white blood cell count >15×109/L within 1 week prior to enrollment; Therapeutic antibiotics given orally or intravenously within 2 weeks prior to enrollment (except for prophylactic antibiotics given intravenously for no more than 48 hours); 3. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) Cardiac insufficiency or color Doppler echocardiogram above grade II according to New York Heart Association (NYHA) criteria: LVEF (left ventricular ejection fraction) 450ms at rest (male); QTc>470ms (female). 4. Subjects with current interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis, organizing pneumonitis (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or active pneumonia or severely impaired lung function on chest CT during the screening period; 5. Subjects with current active tuberculosis; 6. Treatment with a live attenuated vaccine within 4 weeks prior to enrollment, or anticipated need for such a vaccine during the treatment period or within 60 days after the last dose; 7. Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia patients, coagulation mechanism disorders, thrombocytopenia, etc.; Currently receiving full-dose oral or injectable anticoagulant drugs or thrombolytic drugs for therapeutic purposes (prophylactic use of low-dose aspirin is allowed, etc.); 8. Arterial thromboembolic events have occurred within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis above CTCAE level 3, pulmonary embolism, etc.; 9. Severe, unhealed or dehisced wounds and active ulcers or untreated fractures; 10. Major surgical treatment (other than diagnosis) within 4 weeks prior to enrollment or anticipated need for major surgical treatment during the study; 11. Known hypersensitivity to any of the study drugs or excipients; 12. Participation in other drug clinical studies within 4 weeks prior to enrollment; 13. Other factors that the investigator considers unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Sustained time to remission;Safety; | — |
Countries
China
Contacts
Public ContactYong Mao
Affiliated Hospital of Jiangnan University
Outcome results
None listed