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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
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 23, 2021
Last Updated
February 26, 2021
Sponsor
Wuhan Union Hospital, China
Collaborators
BeiGene
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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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