Small cell lung cancer
Conditions
Interventions
control group:Traditional Chinese medicine placebo combined with PD-1/PD-L1 ICIs and etoposide/carboplatin chemotherapy
experimental group:Traditional Chinese medicine granules combined with PD-1/PD-L1 ICIs and etoposide/carboplatin chemotherapy
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed with primary bronchogenic carcinoma according to Western medicine criteria and confirmed as small cell lung cancer (SCLC) through cytological or pathological examination; 2.Clinically staged as extensive-stage SCLC ; 3.Traditional Chinese medicine syndrome differentiation indicates spleen and kidney deficiency syndrome; 4.No prior treatment including chemotherapy radiotherapy immunotherapy or targeted therapy; 5.Eastern Cooperative Oncology Group performance status (PS) score =3 with an estimated survival of at least 3 months; 6.Age between 18 and 80 years (inclusive) with no gender restrictions; 7.Hematological criteria: absolute neutrophil count (ANC) >1.5×10^9/L platelet count (PLT) >80×10^9L hemoglobin (Hb) >100 g/L; normal liver and renal function; 8.Good patient compliance with the ability to understand the study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known allergy to any component of this drug; 2.Pregnant or breastfeeding women; 3.Currently participating in other drug trials; 4.Presence of other malignancies or severe comorbidities; patients with immune system disorders such as HIV/AIDS autoimmune hepatitis systemic lupus erythematosus rheumatoid diseases ankylosing spondylitis Sjögrens syndrome etc.; 5.Patients with mental illness who are unable to comply with the study protocol; 6. Currently participating in other clinical drug trials; 7.Refusal to comply with follow-up requirements; 8.Any other reason that the investigator deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Indicators of Immunity;1-year Survival Rate;Disease Control Rate (DCR);Quality of life;Objective Remission Rate (ORR);Overall Survival (OS);Traditional Chinese Medicine Syndrome Score;Karnofsky Performance Status(KPS); | — |
Countries
CHINA
Contacts
Public ContactLei ZHOU
Department of Oncology Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China
Outcome results
None listed