Non-small cell lung cancer
Conditions
Interventions
Zhengdekang plus immunocombined chemotherapy group:Zhengdekang capsule plus immunization combined with chemotherapy
Immunocombined chemotherapy group:Immunization combined with chemotherapy
Sponsors
Longhua Hospital Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage IIIb-IV non-small cell lung cancer with tumor confirmed by pathology or cytology; According to RECIST version 1.1, there is at least one measurable lesion. TCM diagnosis of lung cancer, TCM syndrome differentiation belongs to Qi-yin deficiency syndrome; 2. Have not received advanced or metastatic systemic anti-tumor therapy before, and plan to conduct first-line immunotherapy combined with chemotherapy. 3. Age =18 years old; 4. Expected survival =3 months; 5. Physical status score (ECOG) =2 points, subjects have no major organ dysfunction Blood routine, liver, kidney and heart function normal: Hemoglobin =80g/L, neutrophil absolute count (ANC) =1.5×10^9/L, platelet =80×10^9/L, bilirubin =1.5×ULN, alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5×ULN. INR=1.5, creatinine =1.5×ULN. 6. Patients with central nervous system metastases may be included if they have received adequate treatment before randomization and have been symptom-free for at least 2 weeks. 7. During first-line chemotherapy combined with immunotherapy, patients with continuous use of proprietary Chinese medicines with clear anti-tumor efficacy (according to the instructions) for =4 weeks could be enrolled after discontinuation, and patients with > 4 weeks could be enrolled after a 4-week washout period. 8. Can understand the situation of this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the components of this drug; 2. Participating in other drug clinical trials; 3. Symptomatic brain metastases; 4. A history of pneumonia with systemic glucocorticoid therapy (excluding daily glucocorticoid replacement therapy for adrenal or pituitary insufficiency) or other immunosuppressive therapy, active autoimmune disease (systemic therapy in the past 2 years), active interstitial lung disease, or prior glucocorticoid therapy. 5. Pregnant or lactating women; 6. People with a history of uncontrollable mental illness. 7. Patients with serious diseases of the heart, liver, kidney and hematopoietic system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Disease Control Rate,DCR;Overall survival, OS;Time to progression,TTP;Quality of life; | — |
Countries
China
Contacts
Public ContactHegen Li
Longhua Hospital Shanghai University of TCM
Outcome results
None listed