A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC

Phase 2 Completed 126 enrolled Fudan University

RandomizedParallel-groupOpen-labelTreatment

Summary

This primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.

Timeline

Start: 2015-09
Primary completion: 2022-09
Completion: 2022-12

Outcome

Missed primary endpoint

paper Compared with radiotherapy alone, concurrent radiotherapy with Huachansu injection did not improve the locoregional control rate or survival rate in elderly patients or chemotherapy-ineligible patients with locally advanced ESCC. PMID 41021440 ↗

Publications

Liu Q, Shen J, Chen Y, Zhou J, Luo H, Deng J, Ai D, Zhu H, Hao S, Zhao K. Phase II trial of radiotherapy plus Huachansu in elderly or chemotherapy-ineligible patients with locally advanced esophageal squamous cell carcinoma. Oncologist. 2025 Oct 1;30(10):oyaf325. doi: 10.1093/oncolo/oyaf325.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Huachansu	Traditional medicine (herbal / TCM)	20 unknown	Other