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Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03377400
Recruitment Status : Active, not recruiting
First Posted : December 19, 2017
Last Update Posted : December 17, 2020
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
Allocation: N/A
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 : June 30, 2021
Estimated Study Completion Date : December 30, 2021

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

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT03377400

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Korea, Republic of
Samsung Medical Center
Seoul, MA, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center
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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 Identifier: NCT03377400    
Other Study ID Numbers: SMC 2017-06-138
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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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, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Antineoplastic Agents, Immunological