To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of Chemoradiation in Combination With Tislelizumab as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05919030
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Tislelizumab
Conditions: Keywords:
Chemoradiation
Immunotherapy
Advanced esophageal cancer
Low PD-L1 expression
Progression-free survival
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity-modulated radiotherapy (IMRT)
Description:
Esophageal primary tumor: 39.6Gy/2.2Gy Bone metastasis: 30Gy/3Gy Lung, liver, brain
metastases, metastatic lymph nodes: 45Gy/3Gy
Arm group label:
Chemoradiation + Tislelizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200 mg IV Q3W
Arm group label:
Chemoradiation + Tislelizumab
Arm group label:
Chemotherapy + Tislelizumab
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
During concurrent radiation therapy: 25 mg/m² IV QW During consolidation therapy: 75
mg/m² IV Q3W
Arm group label:
Chemoradiation + Tislelizumab
Arm group label:
Chemotherapy + Tislelizumab
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
During concurrent radiation therapy: 75 mg/m² IV QW During consolidation therapy: 220
mg/m² IV Q3W
Arm group label:
Chemoradiation + Tislelizumab
Arm group label:
Chemotherapy + Tislelizumab
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must have histologically confirmed squamous cell carcinoma of esophagus
(per AJCC 8th edition).
2. Subjects must have unresectable advanced, recurrent or metastatic ESCC.
3. Subjects must not be amenable to curative approaches such as definitive
chemoradiation and/or surgery.
4. PD-L1 expression (CPS) is less than 10.
5. No prior systemic anticancer therapy given as primary therapy for advanced or
metastatic disease.
6. ECOG Performance Status of 0 or 1.
7. Subjects must have at least one measurable lesion by CT or MRI per RECIST 1.1
criteria; radiographic tumor assessment must be performed within 28 days prior to
randomization.
8. Subjects must have adequate organ and bone marrow function.
Exclusion Criteria:
1. Presence of tumor cells in the brain or spinal cord which are symptomatic or require
treatment.
2. Active known or suspected autoimmune disease.
3. Any serious or uncontrolled medical disorder or active infection.
4. Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS).
5. Any positive test result for hepatitis B or C indicating acute or chronic infection
and/or detectable virus.
6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell
co-stimulation or checkpoint pathways.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Renmin hosptial of Wuhan University
Address:
City:
Wuhan
Zip:
430060
Country:
China
Status:
Recruiting
Contact:
Last name:
Liwei Chen
Phone:
86+15671578311
Email:
wdrmiit@163.com
Start date:
July 1, 2023
Completion date:
July 1, 2027
Lead sponsor:
Agency:
Renmin Hospital of Wuhan University
Agency class:
Other
Source:
Renmin Hospital of Wuhan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919030
