Back to resultsDefinitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Durvalumab
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed squamous esophageal cancer
- The clinical stage T2-3N0M0 or T1-3N1-3M0
- Inoperable case: it refers to medically inoperable status and/or patient's refusal to surgery and/or cervical location and/or locoregionally recurrent tumor after primary surgery
- ECOG PS of 0 to 1
Exclusion Criteria:
- clinical T4 disease (for example, invasion to aorta, vertebral body, or trachea/bronchus) or distant metastasis (M1)
- previously received radiotherapy for esophageal cancer
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study arm
Arm Description
Concurrent radiotherapy with chemotherapy (5FU/CDDP) and immune checkpoint inhibitors (durvalumab/tremelimumab), and followed by consolidation immune checkpoint inhibitors
Outcomes
Primary Outcome Measures
Progression-free survival
Time interval from enrollment to disease progression or death
Secondary Outcome Measures
Full Information
NCT ID
NCT03377400
First Posted
December 14, 2017
Last Updated
December 15, 2020
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03377400
Brief Title
Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer
Official Title
Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent radiotherapy for inoperable locally advanced esophageal squamous cell carcinoma. Four weeks after completion of CCRT combined with immunotherapy, 2 cycles of durvaluma and tremelimumab will be administered every 4 weeks and thereafter durvalumab monotherapy Q4W will be maintained until unacceptable toxicity or disease progression, or for maximum 2 years after enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study arm
Arm Type
Experimental
Arm Description
Concurrent radiotherapy with chemotherapy (5FU/CDDP) and immune checkpoint inhibitors (durvalumab/tremelimumab), and followed by consolidation immune checkpoint inhibitors
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
tremelimumab, 5FU, Cisplatin
Intervention Description
concurrent radiotherapy
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Time interval from enrollment to disease progression or death
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed squamous esophageal cancer
The clinical stage T2-3N0M0 or T1-3N1-3M0
Inoperable case: it refers to medically inoperable status and/or patient's refusal to surgery and/or cervical location and/or locoregionally recurrent tumor after primary surgery
ECOG PS of 0 to 1
Exclusion Criteria:
clinical T4 disease (for example, invasion to aorta, vertebral body, or trachea/bronchus) or distant metastasis (M1)
previously received radiotherapy for esophageal cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Mu Sun, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
MA
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer
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