This is a prospective, randomized, controlled phase II clinical study for evaluating anlotinib combined with concurrent chemoradiotherapy followed by consolidation immunotherapy versus concurrent chemoradiotherapy followed by consolidation immunotherapy in locally advanced, unresectable NSCLC.
This is a prospective, randomized, controlled phase II clinical study for evaluating anlotinib combined with concurrent chemoradiotherapy followed by consolidation immunotherapy versus concurrent chemoradiotherapy followed by consolidation immunotherapy in locally advanced, unresectable NSCLC. In this study, the enrolled patients were divided into the experimental group and the control group at a ratio of 1:1. The patients in the experimental group received anlotinib combined with curative concurrent chemoradiotherapy first, while the patients in the control group received curative concurrent chemoradiotherapy. Those who are evaluated as CR, PR or SD after the aforementioned treatment will enter consolidation immunotherapy. Patients will receive tislelizumab 200mg iv. drip, Q3W, for up to 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Anlotinib 8mg qd po. Taking anlotinib daily for 2 weeks and stop for 1 week.
Docetaxel 25mg/m2 + Cisplatin 25mg/m2 QW
Thoracic radiotherapy was delivered using the daily image-guided intensity modulated radiation therapy (IMRT) technique. The total radiation dose was 66-68 Gy to the gross tumor in 17-22 daily fractions.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
18-months progression-free survival rate
From the first day of treatment to the day of progression or the day of death.
Time frame: 18-months
Overall survival
It was calculated from the first day of treatment to the day of death.
Time frame: 18-months
objective response rate
The proportion patients evaluated for CR and PR
Time frame: 18-months
Incidence of Treatment-related Adverse Events
Adverse effects are graded according to the CTCAE 5.0 version, including multiple organs and tissues, such as gastrointestinal disease and symptom, cardiovascular disease, respiratory diseases and so on.
Time frame: 18 months after therapy
Score of EORTC QLQ-C30
The evaluation of life quality
Time frame: 18 months after therapy
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consolidation Immunotherapy (Tislelizhu 200mg iv. drip, Q3W, up to 12 months.)