Efficiency and Safety of Radiotherapy Combined With Anlotinib in Locally Advanced Non-small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: A Phase II Single-arm Trial
Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.
• ≥18 years old with no restrictions on sex;
• Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;
• Eastern cooperative oncology group (ECOG) score ≤2 was required;
• Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;
• .No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk;
• No symptoms of hemoptysis;
• Adequate hepatic and renal functions with a negative urine protein;
• Expected survival of more than 6 months.