drugset

drugset / Trial / NCT03946969

Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer

NCT03946969 ↗

Phase 2 Unknown 30 enrolled The First Affiliated Hospital with Nanjing Medical University Innovent Biologics (Suzhou) Co. Ltd. · collab

NaSingle-groupOpen-labelTreatment

Summary

This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.

Timeline

Start: 2019-05-09
Primary completion: 2021-11-09
Completion: 2022-10-31

Publications

Chen X, Xu X, Wang D, Liu J, Sun J, Lu M, Wang R, Hui B, Li X, Zhou C, Wang M, Qiu T, Cui S, Sun N, Li Y, Wang F, Liu C, Shao Y, Luo J, Gu Y. Neoadjuvant sintilimab and chemotherapy in patients with potentially resectable esophageal squamous cell carcinoma (KEEP-G 03): an open-label, single-arm, phase 2 trial. J Immunother Cancer. 2023 Feb;11(2):e005830. doi: 10.1136/jitc-2022-005830.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	25 mg/m2	Other
Subject	Paclitaxel	Small molecule	135 mg/m2	Other
Subject	S-1	Small molecule	40 mg	Oral
Subject	Sintilimab	Monoclonal antibody	200 mg	Intravenous

Indications