Lung Neoplasm
Conditions
Interventions
Control group:immune checkpoint inhibitors
Experimental group:Immune checkpoint inhibitor combined with Clostridium butyricum tablets at maintenance phase
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, above 18 years old (including); 2. The patient's ECOG score should be 0-2; 3. The expected survival time is greater than 12 weeks. 4. After histologically or cytologically confirmed metastatic or extensive small cell lung cancer (SCLC), four cycles ofplatinum based doublet-chemotherapy, including at least two cycles of immune checkpoint inhibitor combined with chemotherapy were performed. Subjects were radiologically assessed (RECIST1.1 criteria) as stable disease (SD), partial remission (PR), or complete remission (CR) after the last treatment. (The immune checkpoint inhibitor used were NCCN, ESMO, and CSCO guidelines recommended for extensive SCLC, including but not limited to: Duvaliumab, atrilizumab, Srulizumab, Addebiliumab, etc.). 5. Limited stage SCLC can be enrolled in this study if evaluated chemo-sensitive (relapsed more than 6 months after the end of first-line treatment) when progresses as extensive stage after standard concurrent chemoradiotherapy and meets the 4th inclusion condition. 6. Patients regularly received anti-tumor Chinese patent medicine should be eluted for at least 2 weeks before randomized. 7. There is at least one evaluable lesion (non-intracranial lesion) under RECIST1.1 criteria; 8. Able to swallow pills; 9.blood routine examination: Absolute neutrophil count (ANC) =1.5×109/L or White blood cell count >3.5×109/L, platelet (PLT) =80×109/L, hemoglobin (HGB) =90 g/L; 10. Liver function: serum total bilirubin (TBIL) =1.5 times of the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or Aspertate Aminotransferase (AST) =2.5 times ULN, serum albumin (ALB) =2.8g/dL; 11. Kidney function: serum creatinine (Cr) =1.5×ULN, or creatinine clearance rate=40 mL/min (standard Cockcroft; -Gault formula) For females: CrCl=[(140-age) × weight (kg) × 0.85]/[72 × serum creatinine (mg/dL)] For males: CrCl=[(140-age) × weight (kg) ×1.00]/[72 × serum creatinine (mg/dL)] 12. The subjects and his/her couple are required to use at least one medical approved contraceptive measures (e.g. intrauterine device, contraceptive pill or condom) during the study treatment period and 6 months after the end of study treatment. 13. Before the treatment and sampling (peripheral blood and Defecate) analysis related to this study, the subject can fully understand and cooperate, then an informed consent should be signed.
Exclusion criteria
Exclusion criteria: 1. Patients with active or untreated CNS metastases found by CT scan or MRI during screening and prior radiographic evaluation, and asymptomatic CNS metastases who have previously received treatment, may participate in this study if all of the following criteria are met:? only supratentorial and cerebellar metastases (no metastases from the midbrain, oblongata, medulla oblongata, or spinal cord); ?the CNS disease do not need corticosteroids and there was no evidence of progression on imaging between the end of stereotactic radiotherapy and screening; ? If new asymptomatic CNS metastases was found on screening period, radiation therapy and/or CNS metastases surgery must be performed. 2. Spinal compression that cannot be relieved by surgery and/or radiotherapy, or previously diagnosed spinal compression after treatment without clinical evidence showing stable disease for = 1 week before the treatment period; 3. The third space effusion with clinical symptoms needs repeated drainage (for example, once less than 4 weeks), such as pericardial effusion, pleural effusion and peritoneal effusion that cannot be controlled after thoracentesis or other treatments; 4. Other malignant tumors diagnosed =5 years before the first dose, except for adequately treated carcinoma in situ of cervix, basal cell or squamous cell skin cancer, local prostate cancer after radical mastectomy, and ductal carcinoma in situ after radical mastectomy ( Endocrine therapy for non-metastatic prostate or breast cancer is allowed); 5. Active, known or suspected autoimmune diseases (autoimmune diseases that may exist before enrollment), including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease etc. (1) Type 1 diabetes mellitus (glycemic control with insulin therapy), residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or no replase expected in the absence of external stimulus are allowed; (2) Patients with eczema, psoriasis, lichen simplex chronicus or only skin disease manifestations of vitiligo (psoriatic head arthritis needs to be excluded) if the rash covers area less than 10% of the body surface area, the disease has been adequately controlled at baseline and requires only low potency topical steroids with no acute exacerbations of underlying disease within past 12 months (no psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calcineurin inhibitors, high potency oral steroids) can enter the study: 6. HBsAb positive and HIV DNA copy number greater than 1000 copy number/ml or 200 IU/ml, or HCV positive (HCV RNA or HCV Ab detection indicates acute and chronic infection) or known HIV positive medical history or known Acquired Immunodeficiency Syndrome (Acquired Immunodeficiency Syndrome, AIDs); HCV positive (HCV RNA or HCV Ab detection indicates acute and chronic infection) can be enrolled after control. 7. Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obstructive bronchiolitis), drug-induced pneumonia, radiation-related pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms, or other moderate to severe lung disease seriously affect pulmonary function (patients with a history of radiation pneumonitis (fibrosis) limited in the radiation area can participate in this study); 8. Subjects with active tuberculosis (tuberculosis, TB) o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission;Overall survival time;safety; | — |
Countries
China
Contacts
Public ContactRunXiang Yang
Yunnan Cancer Hospital
Outcome results
None listed