This is a the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety. 23 patients are expected to be enrolled in this study.
Subjects will receive sintilimab 200mg, IV, Q3W and anlotinib 12mg, PO, QD,d1-14, Q3W treatment until disease progression, unacceptable toxicity, or death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
A humanized anti-PD-1 monoclonal antibody
A tyrosine kinase inhibitor selectively targeting VEGFR-2
ORR
Objective response rate according to RECIST v1.1
Time frame: 12 month
DCR
Disease control rate according to RECIST v1.1
Time frame: 12 months
DoR
Duration of response according to RECIST v1.1
Time frame: 12 months
PFS
Progression-free survival according to RECIST v1.1
Time frame: 12 months
OS
Overall survival
Time frame: on average of 2 years
Adverse Event
Evaluation of adverse event rate according to CTCAE v4.03
Time frame: 12 months
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