Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT
Recruiting · NCT07037680 · Interventional (participants receive a specific treatment) · Lead sponsor: JIANYANG WANG
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- ≥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.
Exclusion criteria
- currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ;
- previous malignancy within five years;
- thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months;
- uncontrolled or active pulmonary inflammation;
- participated in other clinical trials;
- Pregnant women.
Where it is running
1 location listed.
- Department of Radiation Oncology,Cancer Institute and Hospital,Chinese - Beijing, Beijing Municipality, China