Inclusion criteria and exclusion criteria
Inclusion criteria | Exclusion criteria |
Aged 18–75 years. | Histologically or cytologically confirmed mixed SCLC. |
Histologically or cytologically confirmed SCLC. | Suitable for surgery. |
Limited stage SCLC. | Patients with other active malignancies within 5 years or at the same time. Localised tumours that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ and breast cancer in situ, are acceptable. |
Score of Eastern Cooperative Oncology Group performance status (ECOG PS) being 0 or 1. | Patients with pleural, pericardial effusions or ascites requiring clinical intervention. |
Without previous anti-tumour treatment history | Uncontrolled or symptomatic hypercalcaemia (>1.5 mmol/L ionised calcium or calcium >12 mg/dL or corrected serum calcium>ULN). |
Without serious abnormalities in haematopoietic function or cardiac, hepatic, or renal function or immunodeficiency. | Patients with peripheral neuropathy≥grade 2 by CTCAE. |
Expected survival of at least 3 months | Patients with HIV, Hepatitis B or C infection. |
Voluntarily participate in this clinical study and signed the informed consent form. | Patients with active pulmonary tuberculosis, previous and current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis and severely impaired pulmonary function as judged by the investigator. |
Subjects with known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to be enrolled. |
CTCAE, Common Terminology Criteria for Adverse Events; SCLC, small-cell lung cancer; ULN, Upper Limit of Normal.