NCT05174325

Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Operable Esophageal Squamous Cell Carcinoma

Phase II Exploratory Study of the Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Single-center, Single-arm Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of sintilimab combined with concurrent chemotherapy as a neoadjuvant treatment for patients with operable esophageal squamous cell carcinoma. It will also evaluate the changes in the immune microenvironment of tumor specimens before and after the medication, and predict the operable period (stage I\~III) Patients with thoracic esophageal squamous cell carcinoma were treated with neoadjuvant chemotherapy combined with PD-1 monoclonal antibody, and the effect of neoadjuvant chemotherapy combined with PD-1 monoclonal antibody was evaluated by detecting the changes of microbial diversity and metabolites in stool samples before and after treatment.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab + chemotherapy	Biological : Sintilimab 100mg: 10ml Method of administration: 200mg IV D1 Q3W. Drug: Cisplatin Injection Specification: 75mg/m2, IV D1 Q3W. Drug: Albumin Paclitaxel Injection specifications: 260mg/m2, IV D1 Q3W.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-06-01
• Completion: 2022-07-01
• First posted: 2021-12-30
• Last updated: 2021-12-30

Locations

1 site across 1 country: China