Lung cancer
Conditions
Interventions
Single arm:Envafolimab combined with albumin-paclitaxel and platinum
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years; (2) Patients with extensive small-cell lung cancer; (3) ECOG PS: 0-1; (4) Good organ function: a) Hematology: WBC =3.0×10^9/L; ANC =1.5×10^9/L; HGB =80 g/L; PLT =100×10^9/L; b) Liver function: TBIL = 1.5 ×ULN; AST, ALT = 2.5 × ULN; c) INR =1.5 ×ULN or PT =1.5 ×ULN or aPTT =1.5 ×ULN; d) Renal function: CREAT < 1.5 ×ULN (5) No prior systemic therapy for SCLC; (6) The estimated survival time is greater than 2 months; (7) Patients volunteer to participate in the study and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Symptomatic brain metastases; (2) Autoimmune disease; (3) Previous exposure to T cell co-stimulation therapy or immune checkpoint inhibitors; (4) Having active infection; (5) Known allergy to the investigational drug: known severe allergic reaction to monoclonal antibodies of any kind; A history of allergy to paclitaxel-albumin or platinum; (6) Pregnant or lactating women; (7) Other conditions that are not suitable for inclusion according to the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Half-year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR;quality of life;adverse effect; | — |
Countries
China
Contacts
Public ContactJian Zhang
Zhujiang Hospital of Southern Medical University
Outcome results
None listed