To assess the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who do not progress after first-line chemoradiotherapy. Based on the incidence and severity of benign and serious adverse events, as well as abnormal laboratory
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Anlotinib Hydrochloride Capsules: multi-target receptor tyrosine kinase inhibitor; TQB2450 injection: programmed cell death protein 1 (PD-1) human monoclonal antibody
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
RECRUITINGAdverse event
Incidence and severity of adverse events
Time frame: Start from the first dose until the last dose to within 84 days after the last dose or start new target indication treatment (whichever occurs first)
serious adverse event
Incidence and Severity of Serious Adverse Events
Time frame: Start from the first dose until the last dose to within 84 days after the last dose or start new target indication treatment (whichever occurs first)
Overall response rate (ORR)
ORR:According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Time frame: Up to approximately 36 months
disease control rate
The percentage of patients who have achieved remission or stable changes in their condition after treatment compared to the evaluable cases
Time frame: Up to approximately 36 months
duration of remission
The time from the first assessment of the tumor as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause
Time frame: Up to approximately 36 months
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