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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
All trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)
Placebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)
Overall Survival
Time frame: up to 3 years
Objective Response Rate
Time frame: up to 3 years
Progression Free Survival
Time frame: up to 3 years
Disease control rate
Time frame: up to 3 years
Duration of Response
Time frame: up to 3 years
Single cell TCR sequencing, whole exome sequencing, RNA seq, and methylation sequencing were performed on tumor tissue and blood samples
Time frame: up to 3 years
Skin adverse reactions
Time frame: up to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 3 years
EORTC QLQ-30
Time frame: up to 3 years
EORTC QLQ-LC13
Time frame: up to 3 years
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