Clinical trial NCT04776590: Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer
Official title: Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by Surgery for Thoracic Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Esophagus Cancer
Neoadjuvant Therapy
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: BeiGene
First posted: 2021-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pathologic complete response rate
timeFrame: 1 day on which pathologic results is reported
Secondary outcomes:
measure: Disease free survival
timeFrame: 2 years after surgery
measure: overall survival
timeFrame: 2 years after enrollment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Kunyu Yang, MD
role: PRINCIPAL_INVESTIGATOR
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