NCT05007145

PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

A Randomized, Open-label, Phase II Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of compare the efficacy and safety of PD-1 inhibitor and chemotherapy（treatment group） with chemoradiotherapy（control group） in neoadjuvant treatment of resectable thoracic esophageal squamous cell carcinoma.

Detailed description

This is a randomized, open-label, phase II study of PD-1 inhibitor combined With neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy in subjects With resectable locally advanced thoracic esophageal squamous cell carcinoma. The patients will be divided into two groups(1:1). In the treatment group, PD-1 inhibitor ,albumin-bound paclitaxel and cisplatin will be given every 3 weeks for 2-4 cycles as neoadjuvant therapy. In the control gourp, albumin-bound paclitaxel and cisplatin will be given every 3 weeks for 2 cycles as neoadjuvant therapy.

Conditions

• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	PD-1 Inhibitor 200mg D1 Q3W
DRUG	Albumin-Bound Paclitaxel	125 mg/m\^2 D1/D8 Q3W
DRUG	Cisplatin	75 mg/m\^2 D1 Q3W
RADIATION	Radiation	40Gy/2.0Gy

Timeline

• Start date: 2021-08-15
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2021-08-16
• Last updated: 2021-12-21

Locations

6 sites across 1 country: China