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Clinical Trial Summary

Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our study found that the mutation spectrum and somatic CNV spectrum of SCCE were similar to those of esophageal squamous cell carcinoma (ESCC). Paclitaxel combined with cisplatin or carboplatin is the first-line treatment for ESCC. JS001 is a Chinese anti-PD-1 monoclonal antibody, which has been approved for the treatment of melanoma. This is a prospective, single arm, single center, phase II clinical trial of JS001 combined with nab-paclitaxel and cisplatin or carboplatin in the first-line treatment of unresectable or advanced SCCE. Aim to evaluate the safety and efficacy of this regimen in patients with unresectable or advanced SCCE.


Clinical Trial Description

Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our previous studies found that the mutation spectrum and somatic CNV spectrum of SCCE were similar to those of esophageal squamous cell carcinoma (ESCC). Paclitaxel combined with cisplatin or carboplatin is a common first-line treatment for ESCC. In addition, some studies have shown that PD-1 mAb combined with paclitaxel chemotherapy in esophageal cancer has better efficacy and tolerability than chemotherapy alone. JS001 is a Chinese monoclonal antibody against PD-1 for injection, which has been approved for the treatment of melanoma. This is a prospective, single arm, single center, phase II clinical trial of JS001 combined with nab-paclitaxel and cisplatin or carboplatin in the first-line treatment of unresectable or advanced SCCE. Aim to evaluate the safety and efficacy of this regimen in patients with unresectable or advanced SCCE. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05173246
Study type Interventional
Source Sun Yat-sen University
Contact Zhi-da Lv, Bachelor
Phone +862087342635
Email lvzd@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date November 17, 2020
Completion date November 17, 2025