small cell lung cancer
Conditions
Interventions
experimental group:Nanoliposomal irinotecan in combination with Cadonilimab
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Understand and be willing to sign written informed consent and be able to follow research protocols for treatment. (2) Age =18 years old and =75 years old. (3) Small cell lung cancer subjects confirmed by histopathology or cytology. (4) The clinical stage was extensive small cell lung cancer by imaging. (5) Previously received first-line systemic therapy. (6) According to RECIST v1.1, subjects must have at least one measurable lesion. (7) ECOG performance status of 0-2. (8) Predicted survival time = 3 months. (9) Adequate organ function. (10) Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, women/menof childbearing age should take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: (1) Previous history of severe allergy to any monoclonal antibody. (2) Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment. (3) Patients with symptomatic brain metastases. (4) Patients with active hepatitis B, hepatitis C, syphilis. (5) Associated with uncontrolled systemic disease. (6) Active autoimmune disease requiring systemic treatment within the last 2 years, and relevant alternative treatments are permitted. (7)Severe diarrhea. (8) Severe mental illness. (9) Irinotecan was used in previous systemic therapy. (10) Patients who have participated in other clinical trials in the past 4 weeks. (11) Received strong inhibitors or inducers of CYP3A4 and CYP2C8, or UGT1A1. (12) The researchers believe that there are other factors that are not suitable for the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate,DCR;Progression-free Survival,PFS;One-year overall survival rate; | — |
Countries
China
Contacts
Public ContactHui Zhu
Cancer Hospital Affiliated of Shandong First Medical University
Outcome results
None listed