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Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03377400
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Jong-Mu Sun, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Durvalumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: study arm
Concurrent radiotherapy with chemotherapy (5FU/CDDP) and immune checkpoint inhibitors (durvalumab/tremelimumab), and followed by consolidation immune checkpoint inhibitors
Drug: Durvalumab
concurrent radiotherapy
Other Names:
  • tremelimumab
  • 5FU
  • Cisplatin




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year ]
    Time interval from enrollment to disease progression or death



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377400


Contacts
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Contact: Jong-Mu Sun, MD 822-3410-1795 jongmu.sun@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, MA, Korea, Republic of, 06351
Contact: Jong-Mu Sun, Associate Professor    82234101795    jongmu.sun@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jong-Mu Sun, MD Samsung Medical Center

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Responsible Party: Jong-Mu Sun, Associated Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03377400     History of Changes
Other Study ID Numbers: SMC 2017-06-138
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Durvalumab
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs