Esophageal Squamous Cell Carcinoma
Conditions
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.
Interventions
DRUGDurvalumab
concurrent radiotherapy
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 1 year | Time interval from enrollment to disease progression or death |
Countries
South Korea
Outcome results
None listed