Small cell lung cancer
Conditions
Interventions
Control group:PD-1 plus chemotherapy
Experimental group:PD-1 combined with chemotherapy + PostbioticsJK-5G
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed small cell carcinoma, extensive-stage small cell Lung cancer (ED-SCLC) according to Veterans Administration Lung Study Group (VALG) stage 2) Age: 18-75 years old, both male and female. 3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-1. 4) life expectancy = 12 weeks. 5) resolution of all acute toxic effects from previous antineoplastic therapy or surgery to grade 0-1 (according to the NCI CTCAE, version 5.0) or to the level specified in the inclusion/exclusion criteria. Other toxicities, such as alopecia, that were deemed by the investigators not to pose a safety risk to patients were excluded. 6) At least one measurable lesion according to RECIST 1.1 criteria. 7) The patient could eat normally through the mouth. 8) Before the first dose of study drug, laboratory values should meet the following conditions: a. blood routine (no blood transfusion or hematopoietic stimulation drugs within 14 days before screening) : white blood cell count (WBC) =3.0 × 10^9/L; absolute neutrophil count (ANC) =1.5 × 10^9/L; platelet (PLT) =100 × 10^9/L; hemoglobin (HGB) =9.0 g/dL; b. Liver function: aspartate transferase (AST) = 2.5x ULN in subjects without liver metastasis; alanine aminotransferase (ALT) =2.5 x ULN, ALT and AST=5 x ULN in patients with liver metastasis; Serum total bilirubin (TBIL) =1.5 x ULN (except Gilbert's syndrome total bilirubin =3.0 mg/dL); c. Renal function: serum creatinine = 1.5x ULN or creatinine clearance rate (CrCl) =50 mL/minute; d. Coagulation function: international normalized ratio (INR) = 1.5x ULN, activated partial thromboplastin time (APTT) of 1.5 x ULN or less (only in patients who are not currently receiving anticoagulant therapy, and those who are currently receiving anticoagulant therapy should be treated with a stable dose of anticoagulant); e. Others: lipase = 1.5x ULN (if lipase > 1.5x ULN without clinical or imaging evidence of pancreatitis); Amylase = 1.5x ULN (if amylase > 1.5x ULN without clinical or imaging evidence of pancreatitis); alkaline phosphatase (ALP) =2.5ULN, liver metastasis or bone metastasis, ALP=5ULN. 9) Female participants of childbearing age must have taken a serum pregnancy test with a negative result within 3 days before starting study medication and be willing to use a medically approved, highly effective contraceptive (e.g., IUD, contraceptive pill, or condom) during the study and for 3 months after last administration of study medication; Male subjects whose partner is a female of reproductive age should be surgically sterilized or agree to use an effective method of contraception for the duration of the study and for 3 months after the last study dose. 10) Patients consented and signed the informed consent, willing and able to follow the planned visits, study treatments, laboratory tests, and other trial procedures .
Exclusion criteria
Exclusion criteria: 1) unable to eat normally by mouth; 2) any prior T cell costimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T cell-targeting drugs; 3) known uncontrolled or symptomatic active central nervous system (CNS) metastases as indicated by the presence of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth. Patients with a history of central nervous system metastases or spinal cord compression could be enrolled if they were clearly treated and had a clinically stable condition 4 weeks after discontinuation of anticonvulsants and steroids before the first study dose. 4) patients with symptoms, visceral spread, and risk of life-threatening complications in the short term (including patients with uncontrollable large amount of exudate [pleural, pericardial, abdominal cavity]), who are not suitable for enrollment after evaluation by investigators; 5) a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or clinically active pneumonitis; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area can participate in this study); 6) presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects controlled only with hormone replacement therapy were eligible]; Subjects with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, type I diabetes mellitus, or asthma that had resolved completely in childhood without any intervention in adulthood were included. Patients with asthma who required medical intervention with bronchodilators were excluded.) 7) active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within 48 weeks or less before screening, with or without treatment; 8) Severe infection at randomization, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.; 9) patients with myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac dysfunction, or clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention within 6 months before study entry; 10)HBsAg positive with HBV DNA copies greater than the upper limit of normal (1000 copies /ml or 500IU/ml), or HCV positive (HCV RNA or HCV Ab test indicated acute or chronic infection); A known history of HIV positivity or known acquired immunodeficiency syndrome (AIDS); 11) had other active malignancies within 2 years before study entry. Exceptions were basal-cell or squamous-cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid that could be treated locally and cured. 12) had undergone major surgery within 28 days before randomization or were scheduled to undergo major surgery during the study period; 13) antineoplastic therapy (including chemotherapy, rad
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Quality Of Life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall survival;Disease Control Rate;Adverse Effects Rate;CD4 +/ CD8+ T lymphocytes count;16S DNA sequencing of gut microbiota;Blood inflammatory cytokines;Metabolomics of blood; | — |
Countries
China
Contacts
Public ContactYu Huiqing
Chongqing University Cancer Hospital
Outcome results
None listed