Esophagus Cancer, Neoadjuvant Therapy
Conditions
Brief summary
Neoadjuvant chemoradiotherapy is recommended as standard therapy for resectable esophageal cancer. The recurrence rate after surgery following neoadjuvant chemoradiotherapy is about 35%. Whether achieving pathological complete response after neoadjuvant chemoradiotherapy is significantly associated with recurrence after surgery. It is reported that immunotherapy combined with chemotherapy improved survival compared with chemotherapy alone in first line therapy of advanced esophageal cancer. We hypothesize that the addition of immunotherapy to neoadjuvant chemoradiotherapy is helpful to improving pathologic complete response and survival.
Interventions
DRUGTislelizumab
neoadjuvant immunotherapy
Sponsors
BeiGene
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Pathologically diagnosed as esophageal squamous cell carcinoma * Initially diagnosed as thoracic esophageal cancer * resectable or potantially resectable * II-IVA according to AJCC 8th edition； * KPS≥70 * Adequate organ function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response rate | 1 day on which pathologic results is reported | Pathologic complete response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 2 years after enrollment | overall survival |
| Disease free survival | 2 years after surgery | Disease free survival |
Countries
China
Outcome results
None listed