drugset

drugset / Trial / NCT02649361

Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102)

NCT02649361 ↗

Phase 2 Completed 164 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC).

Timeline

Start: 2016-01
Primary completion: 2018-07-23
Completion: 2018-07-23

Outcome

Met primary endpoint

paper Median PFS was 3.02 months (95% CI 2.63-3.65) in the anlotinib group and 1.41 months (95% CI 1.38-1.41) in the placebo group PMID 33586360 ↗

paper hazard ratio 0.46 [95% CI 0.32-0.66]; p < 0.001). PMID 33586360 ↗

Publications

Huang J, Xiao J, Fang W, Lu P, Fan Q, Shu Y, Feng J, Zhang S, Ba Y, Zhao Y, Liu Y, Bai C, Bai Y, Tang Y, Song Y, He J. Anlotinib for previously treated advanced or metastatic esophageal squamous cell carcinoma: A double-blind randomized phase 2 trial. Cancer Med. 2021 Mar;10(5):1681-1689. doi: 10.1002/cam4.3771. Epub 2021 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Catequentinib	Small molecule	12 mg	Oral

Indications