Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer
- Registration Number
- NCT03377400
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description study arm Durvalumab Concurrent radiotherapy with chemotherapy (5FU/CDDP) and immune checkpoint inhibitors (durvalumab/tremelimumab), and followed by consolidation immune checkpoint inhibitors
- Primary Outcome Measures
Name Time Method Progression-free survival 1 year Time interval from enrollment to disease progression or death
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, MA, Korea, Republic of