drugset

drugset / Trial / NCT04548440

Efficacy and Safety of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in BR-ESCC Patients

NCT04548440 ↗

Phase 2 Completed 50 enrolled Sun Yat-sen University Cancer Center CSPC Pharmaceutical Group Limited · collab Innovent Biologics (Suzhou) Co. Ltd. · collab

NaSingle-groupOpen-labelTreatment

Summary

An open-label, non-randomized, phase II study to assess the safety and efficacy of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Cell Carcinoma patients

Timeline

Start: 2020-08-31
Primary completion: 2022-12-31
Completion: 2022-12-31

Publications

Wu JD, Wang DS, Wang ZQ, Li QQ, Xu BY, Ren C, Fang CY, Huang Y, Li ZC, Chen JY, Tan Q, Li YH, Yang H. Sintilimab plus cisplatin and nab-paclitaxel induction treatment for locally advanced borderline-resectable oesophageal squamous cell carcinoma: A single-arm, prospective, phase 2 study (NEOCRTEC2001). Clin Transl Med. 2026 May;16(5):e70691. doi: 10.1002/ctm2.70691.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Nab-paclitaxel	Small molecule	125 mg/m2	Intravenous
Subject	Sintilimab	Monoclonal antibody	200 mg	Intravenous

Indications