drugset / Trial / NCT03904927
Local Therapy for Oligorecurrent and Oligometastatic Esophageal Squamous Cell Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the study is to determine if intervening with combined local therapy and chemotherapy prior to chemotherapy alone in patients with oligorecurrent and oligometastatic esophageal squamous cell carcinoma led to significant improvements in progression-free survival (PFS).
Timeline
- Start
- 2019-02-01
- Primary completion
- 2022-01-01
- Completion
- 2024-09-15
Outcome
Met primary endpoint
paper (stratified hazard ratio 0·26 [95% CI 0·16-0·42]; stratified log rank p<0·0001). PMID 37980921 ↗
Publications
- Liu Q, Chen J, Lin Y, Ye J, Shen W, Luo H, Li B, Huang W, Wei S, Song J, Wang Y, Yang H, Lai S, Zhu H, Ai D, Chen Y, Deng J, Hao S, Zhao K. Systemic therapy with or without local intervention for oligometastatic oesophageal squamous cell carcinoma (ESO-Shanghai 13): an open-label, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):45-55. doi: 10.1016/S2468-1253(23)00316-3. Epub 2023 Nov 18.
- Liu Q, Chen J, Li B, Ye J, Wei S, Wang Y, Yang H, Zhu Z, Lai S, Li L, Chen Y, Wang J, Xiang J, Zhao K. Local therapy for oligometastatic esophageal squamous cell carcinoma: a prospective, randomized, Phase II clinical trial. Future Oncol. 2021 Apr;17(11):1285-1293. doi: 10.2217/fon-2020-0873. Epub 2021 Feb 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Systemic therapy | Unknown | 75 mg/m2 | Intravenous |