Fuyang Health Science and Technology Research Project
Conditions
Interventions
Intervention group:Maintenance therapy with Aderbelimab combined with low-dose Apatinib
Control group:Standard immunotherapy maintenance treatment or observation
Sponsors
The Second People's Hospital of Fuyang
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Age: >= 18 years old; 2. Gender: Not limited; 3. Patients with extensive-stage small cell lung cancer (ES-SCLC) confirmed by histopathological or cytological examination; 4. According to the RECIST v1.1 criteria, subjects must have measurable target lesions detected by CT or MRI. Tumor imaging assessment should be performed within 28 days before the first medication; 5. ECOG performance status (PS) score: 0-2; 6. Expected survival time of no less than 12 weeks; 7. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up; 8. The investigator deems that the patient can benefit.
Exclusion criteria
Exclusion criteria: 1. Patients without measurable lesions are excluded; 2. Subjects who have confirmed allergies to the investigational drug and/or its excipients, or who have autoimmune diseases; 3. Presence of third-space effusion (such as massive pleural effusion and ascites) that cannot be controlled by drainage or other methods; 4. Use of steroids for more than 50 days, or requiring long-term steroid use; 5. Uncontrolled symptomatic brain metastases or mental abnormalities that prevent correct expression of subjective symptoms; 6. Pregnant or lactating women, or those of childbearing potential who refuse to use contraceptive measures; 7. Individuals with severe heart disease or a history thereof, including: documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina requiring drug treatment, clinically confirmed valvular heart disease, severe history of myocardial infarction, and refractory hypertension; 8. History of allogeneic tissue/solid organ transplantation; 9. In the judgment of the investigator, presence of concomitant diseases that seriously endanger the subject's safety or affect the subject's ability to complete the study (such as clinically uncontrolled hypertension, diabetes, thyroid diseases, etc.); 10. Other circumstances determined by the investigator as unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective response rate;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactHui Shen
The Second People's Hospital of Fuyang
Outcome results
None listed