Non Small Cell Lung Cancer
Conditions
Interventions
Experimental group:PD1 associated with intestinal flora+ targeted agents or chemotherapy
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients have good compliance,can understand the study process and sign written informed consent; 2.Age >=18 years; 3.Expected survival >=12 weeks; 4.Patients with primary non-small cell lung cancer diagnosed histologically and no indications for surgery; 5.ECOG score =1.5x10^9/L; PLT>=100x10^9/L; TBIL60 mL/min (Cockcroft-Gault); APTT,INR,PT<= 1.5 ULN; 9.Women who are not pregnant or breastfeeding ;Women/men of childbearing age should use effective contraceptive methods during the study period and for 6 months after completion of study treatment.
Exclusion criteria
Exclusion criteria: 1.Previous treatment with other types of immune checkpoint inhibitors. 2.The patient who get live virus vaccine in the last 30 days before treatment. Allow the use of seasonal influenza vaccines that do not contain live virus. 3.The patient who have previous malignant tumor disease history, cured and no evidence of disease recurrence within 5 years after the start of treatment. 4.Meningitis with known active CNS metastasis and/or cancer; 5.The patient who a history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); With the exception of vitiligo or cured childhood asthma/allergies without any intervention in adults; Autoimmune-mediated hypothyroidism treated with a steady dose of thyroid replacement hormone; Type I diabetes with a steady dose of insulin. 6.The patient who have a history of immunodeficiency, including positive HIV antibody test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation. 7.The patient who have cardiovascular without control and have clinical symptoms or disease, such as: (1)The NYHA class II above heart failure; (2)Unstable angina pectoris; (3)Had a myocardial infarction within 6 months; (4)Clinically significant supraventricular or ventricular arrhythmias are poorly controlled without or after clinical intervention; 8.Patient who have had severe allergic reactions to other monoclonal antibody treatment. 9.Patient who are receiving long-term systemic steroid therapy.Patients with asthma requiring intermittent bronchodilators, inhaled steroids, or local steroid injections are not excluded. 10.Patient who an active infection requiring treatment. 11.Patients with active TB infection detected by history or CT examination, or with active TB infection in 1 year before enrollment, or with active TB infection more than 1 year before . 12.Patient with HBsAg (+) and/or HBcAb (+) were enrolled with HBV-DNA >=500 IU/mL or 2500 copies /mL. Those above this threshold were eligible for enrolment unless they first received antiviral therapy, were required to drop to the normal range for at least 2 weeks, and had to continue antiviral therapy throughout the study period. For subjects who were receiving antiviral therapy at the time of prior treatment or screening, they must continue to receive antiviral therapy throughout the study period, even if their HBV-DNA met the eligibility criteria. Hepatitis C (HCV antibody positive and HCV-RNA positive). 13.The patient who receive probiotic-related products in the previous 14 days. 14.pregnancy or breastfeeding, or pregnancy during the period of contraception required during the study medication and after the last administration of the study medication; 15.Other circumstances deemed unsuitable for participation in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the number of intestinal flora;Immune function assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;progression free survival;overall survival;inflammatory index;Subjective global nutritional status scale assessment, body composition analysis, serum albumin, prealbumin, etc;safety;living quality; | — |
Countries
China
Contacts
Public ContactLi Suyi
Anhui Provincial Cancer Hospital
Outcome results
None listed