non-small cell lung cancer
Conditions
Interventions
Experimental group:JPGC formula orally
Sponsors
Shanghai TCM-integrated Hospital, Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients with non-small cell lung cancer confirmed by pathology and classified as stage IIB-IV who do not meet the surgical indications according to the 8th edition of the UICC; 2) Be willing to receive immunotherapy; 3) No antibiotics, systemic corticosteroids (or a prednisone dose of less than 10mg per day), or other immunosuppressants were used within one month before enrollment. 4) No inflammatory bowel disease, radiation enteritis, rheumatism or immune diseases, etc. 5) No other serious complications; 6) Age: 18-80 years old, gender not limited; 7) ECOG=2 points, expected survival period =3 months; 8) Baseline laboratory tests met the following criteria: Neutrophils =1.5×10^9/L, platelets =70×10^9/L, hemoglobin =9.0g/dL, serum aspartate aminotransferase (AST) = 5 times the upper limit of normal value (ULN), alanine aminotransferase (ALT) = 5 times the upper limit of normal value (ULN), serum creatinine =ULN to 1.5 times INR 3.5g/dL, total bilirubin < 2mg/dL.
Exclusion criteria
Exclusion criteria: 1) Those with severe primary diseases such as cardiovascular and cerebrovascular diseases, as well as mental disorders; 2) Those with poor compliance and incomplete data during the clinical research process; 3) Those with an unclear diagnosis; 4) Subjects who are unable to comply with the provisions of this experimental protocol; 5) Subjects whose observation items were incomplete and whose experimental effects and side effects could not be evaluated; Those who have participated in other clinical trials within the past three months; 7) Pregnant or lactating patients; 8) Those who have received other immune-related treatments or other treatments that may affect immune function; 9) Those who, during the medication process, contract other diseases due to non-drug factors and are unable to continue the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM syndrome scoring;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dicease Control Rate;Objective response rate;Tumor markers CEA, CYFRA211, and NSE;Lymphocyte subsets;Cytokine;Indicators for assessing inflammation and immune status;Quality of life score;16S rRNA sequencing of intestinal flora; | — |
Countries
China
Contacts
Public ContactYi Zhong
Shanghai TCM-integrated Hospital, Shanghai University of TCM
Outcome results
None listed