Actively Recruiting
A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma
Led by Renmin Hospital of Wuhan University · Updated on 2024-11-14
155
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.
CONDITIONS
Official Title
A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the esophagus (per AJCC 8th edition)
- Unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma
- Not suitable for curative treatments like definitive chemoradiation or surgery
- PD-L1 expression (CPS) less than 10
- No prior systemic anticancer therapy for advanced or metastatic disease
- ECOG Performance Status of 0 or 1
- At least one measurable lesion by CT or MRI per RECIST 1.1 criteria, with tumor assessment within 28 days before randomization
- Adequate organ and bone marrow function
You will not qualify if you...
- Presence of symptomatic tumor cells in the brain or spinal cord requiring treatment
- Active known or suspected autoimmune disease
- Serious or uncontrolled medical disorder or active infection
- Positive test history for HIV or AIDS
- Positive test for hepatitis B or C indicating acute or chronic infection or detectable virus
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or drugs targeting T-cell co-stimulation or checkpoint pathways
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Renmin hosptial of Wuhan University
Wuhan, Hubei, China, 430060
Actively Recruiting
Research Team
Y
Yongshun Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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