Stage IIIB-IV non-small cell lung cancer
Conditions
Interventions
Treatment group:Jianpi Guchang prescription, 1 bag each time, twice a day. Combined with immunotherapy (PD-1 checkpoint inhibitors: carrelizumab, sintilumab, etc.), AP/AC chemotherapy regimen is used
Control group:The control group received oral granules at 1/10 of the original dose of the treatment group, and other treatment options were the same as those in the treatment group. Every 21 days is
Sponsors
Shanghai TCM-Intergrated Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) A patient with pathologically confirmed non-small cell lung cancer and stage IIIB-IV who did not meet the surgical indications according to UICC version 8; 2)It conforms to traditional Chinese medicine syndrome differentiation and is classified as spleen deficiency syndrome; 3) Willing to receive immunotherapy; 4) No antibiotics, systemic corticosteroids (or prednisone doses less than 10mg/day) or other immunosuppressants were used within 1 month before enrollment; 5) No inflammatory bowel disease, radiation enteritis, rheumatic immunity and other diseases; 6) No other serious complications; 7) Age 18-80 years old, male or female; 8) ECOG=2, estimated survival time =3 months; 9)Baseline laboratory tests met the following criteria: neutrophils =1.5×10^9/L, platelets =70×10^9/L, hemoglobin = 9.0 g/dL, serum aspartate aminotransferase (AST) = 5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) = 5 times the upper limit of normal (ULN), serum creatinine =ULN to 1.5 times, INR<1.7 or prothrombin time (PT) 3.5 g/dL, and total bilirubin <2mg/dL.
Exclusion criteria
Exclusion criteria: 1) Those with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, as well as mental illness; 2) Poor compliance and incomplete data during clinical research; 3) The diagnosis is unclear; 4) Subjects who cannot perform the provisions of this experimental protocol; 5) Subjects whose observation items are incomplete and cannot evaluate the test effect and side effects; 6) Those who have participated in other clinical trials in the past 3 months; 7) Patients who are pregnant or breastfeeding; 8) Those who have received other immune-related therapies or other therapies that may affect immune function; 9) During the medication process, those who suffer from other diseases due to non-drug factors and cannot continue to complete treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM syndrome score;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal barrier;Intestinal flora;Inflammatory cytokines;T cell subsets;KPS score;ECOG score; | — |
Countries
China
Contacts
Public ContactYi Zhong
Shanghai TCM-Intergrated Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China
Outcome results
None listed