Clinical trial · Interventional
Adjuvant Durvalumab for Esophageal Cancer
Randomised, Double-blind, Phase II Trial of Adjuvant Durvalumab or Placebo for Completely Resected Esophageal Squamous Cell Carcinoma Previously Treated With Neoadjuvant Concurrent Chemoradiotherapy
NCT02520453CI-TRIAL-00042119unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Durvalumab
- description
- Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
- interventionNames
- Drug: Durvalumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous esophageal cancer, irrespective of PD-L1 status * The enrolment should be done during the time interval from 20 days to 56 days after complete resection after neoadjvuant CCRT (no residual tumor after operation) * Clinical tumor stage before neoadjuvant CCRT should be T3-4N0M0 or T1-4N1-3M0 * Available tumor specimen for biomarker analysis acquired before neoadjuvant CCRT or at operation Exclusion Criteria: * Other PD-1 or PD-L1 inhibitors history * Mean QT interval corrected for heart rate (QTc) ≥470 ms using Bazett's correction * Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid * Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
References
Publications (0)
Data not yet available
No reference posted for this study.