Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer

Phase 2 Unknown 130 enrolled First People's Hospital of Hangzhou

RandomizedParallel-groupOpen-labelTreatment

Summary

To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.

Timeline

Start: 2015-01
Primary completion: 2017-12
Completion: 2018-12

Outcome

Met primary endpoint

paper Median OS was 24.0 (95% CI, 22.2-25.8) months in the RT plus icotinib group vs 16.3 PMID 33026449 ↗

paper (hazard ratio, 0.53; 95% CI, 0.33-0.87; P = .008). PMID 33026449 ↗

Publications

Luo H, Jiang W, Ma L, Chen P, Fang M, Ding L, Hua Y, Du D, Jing Z, Xie R, Song Y, Wang J, Zhou R, Tian Z, Wu S. Icotinib With Concurrent Radiotherapy vs Radiotherapy Alone in Older Adults With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019440. doi: 10.1001/jamanetworkopen.2020.19440.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Icotinib	Small molecule	125 mg	Oral