NCT06703047

Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma: a Prospective, Double-blind, Multicenter, Randomized Controlled Phase II Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Tislelizumab combined with chemotherapy and all trans retinoic acid for locally advanced or metastatic esophageal squamous cell carcinoma: a prospective, double-blind, multicenter, randomized controlled phase II trial

Detailed description

This study is a prospective, double-blind, multicenter, randomized controlled phase II clinical trial of tislelizumab combined with chemotherapy and all trans retinoic acid in the treatment of locally advanced non-surgical or metastatic esophageal squamous cell carcinoma. The aim is to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and all trans retinoic acid in the treatment of locally advanced non-surgical or metastatic esophageal squamous cell carcinoma. Patients with locally advanced inoperable or metastatic ESCC can only be enrolled after meeting the criteria. They will receive treatment with tislelizumab combined with chemotherapy+all trans retinoic acid or tislelizumab combined with chemotherapy+placebo, with a treatment cycle of every 3 weeks. The treatment will continue until disease progression or reaching the criteria for terminating the study drug treatment, for a maximum of two years.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	ATRA+pd-1+chemo	All trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)
DRUG	placebo+PD-1+chemo	Placebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)

Timeline

• Start date: 2024-11-20
• Primary completion: 2029-11-20
• Completion: 2030-10-24
• First posted: 2024-11-25
• Last updated: 2024-11-25