NCT05603065

Tislelizumab With Chemotherapy or Radiation for Neoadjuvant Therapy of Esophageal Squamous Cell Carcinoma (TINES)

A Randomized, Open-label, Uncontrolled Study of Tislelizumab in Combination With Chemotherapy or Radiation Therapy for Neoadjuvant Therapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma (TINES)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Esophageal squamous cell carcinoma (ESCC), one of the most common subtypes of esophageal cancer, has a poor prognosis and low 5-year overall survival. At present, the treatment of ESCC includes chemotherapy, immunity, radiotherapy, surgery and other methods, and in recent years, the treatment regimen of immune combined chemotherapy has begun to show results in the treatment of esophageal cancer. Tislelizumab has demonstrated good efficacy in advanced esophageal cancer and in the second- and third-line treatment. At present, neoadjuvant immunization is carried out less, and neoadjuvant immunization plus chemoradiotherapy has been achieved With a pCR rate of 55.6 and AEs of grade III and above 65%, and studies have shown that radiotherapy has immunosensitizing and coordinating effects, whether immunotherapy combined with radiotherapy has a better efficacy is worth further investigation. This review intends to conduct a randomized, open-label, uncontrolled study of tislelizumab in combination with chemotherapy or radiation therapy for neoadjuvant therapy for resectable locally advanced thoracic esophageal squamous cell carcinoma with a view to providing a new option for resectable locally advanced ESCC.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab + cisplatin + paclitaxel	Tislelizumab 200mgD1 + cisplatin 75mg/m\^2D1 + paclitaxel 150mg/m\^2D1 Q3W 3 cycles
DRUG	Tislelizumab + radiotherapy	Tislelizumab 200mgQ3W 3 cycles + radiotherapy (23 times in total, 1.8 Gy per dose, 5 times a week)

Timeline

• Start date: 2022-10-10
• Primary completion: 2023-10-01
• Completion: 2024-10-01
• First posted: 2022-11-02
• Last updated: 2023-06-29

Locations

1 site across 1 country: China