Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer (CRISEC)
Primary Purpose
Esophagus Cancer, Neoadjuvant Therapy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Esophagus Cancer
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
Sites / Locations
- Union HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tislelizumab arm
Arm Description
Radiotherapy: PTV 41.4Gy in 23 Fractions,5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg per square meter of body-surface area weekly) and Caboplatin (area under the curve of 2 mg per milliliter per minute weekly) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks)
Outcomes
Primary Outcome Measures
Pathologic complete response rate
Pathologic complete response rate
Secondary Outcome Measures
Disease free survival
Disease free survival
overall survival
overall survival
Full Information
NCT ID
NCT04776590
First Posted
February 23, 2021
Last Updated
February 26, 2021
Sponsor
Wuhan Union Hospital, China
Collaborators
BeiGene
1. Study Identification
Unique Protocol Identification Number
NCT04776590
Brief Title
Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer
Acronym
CRISEC
Official Title
Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by Surgery for Thoracic Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
February 15, 2023 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
Collaborators
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Neoadjuvant Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tislelizumab arm
Arm Type
Experimental
Arm Description
Radiotherapy: PTV 41.4Gy in 23 Fractions,5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg per square meter of body-surface area weekly) and Caboplatin (area under the curve of 2 mg per milliliter per minute weekly) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks)
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
neoadjuvant immunotherapy
Primary Outcome Measure Information:
Title
Pathologic complete response rate
Description
Pathologic complete response rate
Time Frame
1 month after surgery
Secondary Outcome Measure Information:
Title
Disease free survival
Description
Disease free survival
Time Frame
2 years after first medication of Tislelizumab
Title
overall survival
Description
overall survival
Time Frame
2 years after first medication of Tislelizumab
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsong Yang, MD
Phone
18271451606
Email
ray63@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunyu Yang, MD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsong Yang, MD
Phone
18271451606
Email
ray63@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer
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