NCT04844385

Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

A Prospective Single-arm Phase Ⅱ Study of Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

Detailed description

This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma. All patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. Then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (PO 1000 mg/m2, bid, d1-d14, q3w).

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240 mg, d1, Q3w for two cycles
DRUG	Paclitaxel-albumin	Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles
DRUG	Nedaplatin	Nedaplatin 75mg/m2, d1, Q3w for two cycles
RADIATION	radiation therapy at a total dose 60 Gy	Radiation therapy at a total dose 60 Gy
DRUG	Capecitabine	Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy
RADIATION	radiation therapy at a total dose 50 Gy	Radiation therapy at a total dose 50 Gy

Timeline

• Start date: 2021-02-20
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2021-04-14
• Last updated: 2024-02-09

Locations

1 site across 1 country: China