Trials / Unknown
UnknownNCT03377400
Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer
Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Samsung Medical Center · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | concurrent radiotherapy |
Timeline
- Start date
- 2017-12-14
- Primary completion
- 2021-06-30
- Completion
- 2021-12-30
- First posted
- 2017-12-19
- Last updated
- 2020-12-17
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03377400. Inclusion in this directory is not an endorsement.