NCT05469061

Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC

The Safety and Efficacy of Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC，A Single-arm Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a single-arm，open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.

Conditions

• Esophageal Squamous Cell Carcinoma
• Locally Advanced Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	The 1st to 3rd doses were administered concurrently with FP regimen chemotherapy, 200 mg Tislelizumab each, on D1, D22 and D43 by intravenous infusion. In patients with successful conversion, one dose of 200 mg was administered 21 days after surgery in concurrent with the 4th to 6th cycles of 5-Fu, then 6 cycles of 200 mg Tislelizumab as adjuvant therapy; in patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
DRUG	5-FU	A FP regimen with 5-Fu 850mg/m\^2 d1-4 + cis-platinum 850mg/m\^2 d1-4 was used, on D1, D22 and D43 infused intravenously. 3 cycles of 5-Fu 850mg/m\^2 d1-4 adjuvant chemotherapy were started at 21 days after surgery in patients with a successful conversion. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
DRUG	cis Platinum	A FP regimen with 5-Fu 850mg/m\^2 d1-4 + cis-platinum 850mg/m\^2 d1-4 was used, on D1, D22 and D43 infused intravenously. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-08-01
• Completion: 2022-11-01
• First posted: 2022-07-21
• Last updated: 2022-07-21

Locations

1 site across 1 country: China