Concurrent or sequential chemoradiotherapy has been recommended as the standard treatment for locally advanced and unresectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. PD-1/PD-L1 inhibitors have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents have also been used for the first-line treatment of advanced or metastatic NSCLC. Therefore, we designed this single-arm clinical trial, which aims to investigate the safety and feasibility of sintilimab combined with anlotinib therapy for patients with initially unresectable stage II-III NSCLC.
Concurrent or sequential chemoradiotherapy is the standard treatment for patients with locally advanced NSCLC, but patients receiving chemoradiotherapy have limited improvement in prognosis and are almost impossible to achieve a radical cure. Considering the excellent effect of immunotherapy and anti-angiogenesis therapy in NSCLC, we designed this single-arm clinical study, which aims to investigate the safety and feasibility of sintilimab combined with anlotinib therapy for patients with initially unresectable stage II-III NSCLC, in order to enable patients to achieve further surgical treatment and prolonged survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Sintilimab will be given intravenously at a dose of 200mg every 21 days.
Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.
Surgical conversion rate
The surgical conversion rate was defined as the proportion of subjects with the successful conversion over all subjects who received the tested regime.
Time frame: 18 weeks from the initiation of the tested regime therapy
Objective response rate (ORR)
ORR is defined as the percentage of participants who have the best overall response (BOR) of complete response (CR) or partial response (PR) assessed based on RECIST 1.1.
Time frame: 18 weeks from the initiation of the tested regime therapy
R0 resection rate
R0 resection rate is defined as the complete resection rate of all tumor under microscope.
Time frame: within 28 working days after operation
Major pathological response rate
Major pathological response rate is defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%).
Time frame: within 28 working days after operation
Pathological complete response rate
Pathological complete response rate is defined as the percentage of patients who achieved a pathological complete response (residual tumor = 0%).
Time frame: within 28 working days after operation
Overall survival (OS)
OS is measured from the time from the treatment onset (date of first study dose) until the date of death from any cause.
Time frame: 2 years from the initiation of the tested regime therapy
Progression-free survival (PFS)
PFS is measured from the time from the treatment onset (date of first study dose) until the date of tumor progression or death from any cause.
Time frame: 2 years from the initiation of the tested regime therapy
Disease-free survival (DFS)
DFS is measured from the time from radical surgery until the date of tumor progression or death from any cause.
Time frame: 2 years from the initiation of the tested regime therapy
Treatment-related adverse events
Incidence and grade of treatment-related adverse events assessed based on CTCAE 5.0
Time frame: 3 months from the end of the tested regime therapy
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