The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1/L1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) , disease control rate (DCR) and safety.
1. At the time of signing the informed consent form, both men and women must be at least 18 years old.
2. Widespread recurrent small cell lung cancer diagnosed by histology or cytology and progressing after 3 months of standard immunization.
3. According to RECIST 1.1 criteria, patients must have at least one measurable lesion (lesions that have undergone radiotherapy must show clear progression in order to be considered measurable lesions).
4. ECOG PS score: 0-1 points.
1. Imaging shows that the tumor has invaded large blood vessels or has unclear boundaries with blood vessels.
2. Imaging shows the presence of obvious pulmonary hollow or necrotic tumors.
3. Symptomatic central nervous system metastases (such as brain metastases or meningeal metastases).
4. Patients with conditions such as malignant meningitis and spinal cord compression.
Single group
sintilimab combined with anlotinib
DrugPatients who met the inclusion criteria were treated with Sintilimab plus anlotinib every 3 weeks until disease progression or intolerable adverse reactions or death(up to 24 months).
ORR
the rate of patients with PR and CR
OS
The time from the beginning of treatment to the time when the patient dies from any cause
PFS
The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause
AE
Safety will be evaluated by AE
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