Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC

Exclusion Criteria

• •1. Participants who were diagnosed as mixed pathological type of small cell lung cancer
• •2. Participants who had long-term use of metformin (\>2 weeks) 6 months prior to study entry, or diagnosed with type-2 diabetes,
• •3. Participants received treatment with anti-PD1, -PDL1, -CTLA4, -CD137 inhibitors before, or any therapy specifically targeting T-cell co-stimulation or checkpoint pathways.
• •4. Participants received cellular immunotherapy before
• •5. Participants with Uncontrolled intercurrent illness including, but not limited to:
• •Ongoing or active infection; Known history of Human Immunodeficiency Virus (HIV) infection Acute or chronic active hepatitis B (HBV DNA \>1\*10\^3 copies/ml or \>200 IU/mL) or, acute or chronic active hepatitis C (with a positive Hepatitis C antibody test result) Active tuberculosis Congestive heart failure (Class III-IV, according to New York Heart Association classification), or and clinically significant Cardiac arrhythmia if poorly controlled; Uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) Any arterial thrombosis, embolism, ischemia, myocardial infarction, unstable angina, or cerebrovascular accident within 6 months prior to enrollment,
• •6. Participants with symptomatic Central nervous metastasis or meningeal carcinomatosis are excluded; Participants with asymptomatic brain metastases or with brain metastases that have been treated and stable in a subsequent scan are allowed to include if there is measurable lesion outside the Central nervous system and no history of intracranial hemorrhage, and not midbrain, pons, cerebellum, medulla or spinal cord metastasis, and do not need glucocorticoid therapy.
• •7. Participants receiving glucocorticoid (\>30 mg prednisone equivalent a day) or any Immunosuppressive drug within 14 days prior to study recruitment; Participants receiving inhaled or Topical corticosteroids, adrenal corticosteroid replacement therapy (\>10 mg prednisone equivalent a day) are allowed if they have no active autoimmune disease
• •8. Participants with a known additional malignancy (Except for Non-melanoma skin cancer and the following in situ carcinoma: in situ bladder carcinoma, in situ gastric carcinoma, in situ colonic carcinoma, in situ endometrial carcinoma, in situ cervical carcinoma /dysplasia, in situ melanoma carcinoma and in situ breast Carcinoma) unless they Maintained Complete Remission for at least 5 years and do not need corresponding treatment during the study
• •9. Participants who have not recovered (i.e., ≤ Grade 1 according to NCI CTCAE V4or at baseline) from adverse effects due to a previously administered agent.
• •10. Participants who have uncontrollable effusion, such as pleural and ascites that cannot be controlled by drainage or other treatment
• •11. Patients who have active autoimmune diseases; excluding patients whose active autoimmune disease is caused by Vitiligo or asthma that is completely relieved in childhood and Patients with hypothyroidism requiring only hormone replacement therapy
• •12. Patients with known Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
• •13. Patients who are pregnant or breastfeeding,
• •14. Patients who are allergic to monoclonal antibody drugs
• •15. Patients who have contraindications to metformin including severe allergic reactions and intolerance