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NCT03377400 Clinical Trial

Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03377400
Other study ID # SMC 2017-06-138
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 14, 2017
Est. completion date December 30, 2021

Study information
Verified date December 2020
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date December 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Durvalumab
concurrent radiotherapy

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul MA

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival Time interval from enrollment to disease progression or death 1 year
See also
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