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Durvalumab after chemoradiation in rectal cancer
NCT04083365Phase 2
Key facts
- Status
- Unknown
- Start
- Jan 2020
- Primary completion
- Nov 2022
- Countries
- 1
- Sponsor
- AUSL Romagna
- Drugs
- durvalumab
- Conditions
- rectal cancer
01
Overview
Phase 2, open-label trial of durvalumab in rectal cancer, sponsored by AUSL Romagna. Status: unknown.
02
Design
- Study design
- Non-randomizedOpen-labelSingle group
03
Who it enrols
Patients with operable stage II-III rectal adenocarcinoma, ECOG 0-1, adequate organ function, and no prior PD-1/PD-L1 inhibitor treatment.
04
Registry description
This is a prospective phase II, open label, single arm, multi-centre study to evaluate activity of an innovative sequence on capecitabine plus concomitant radiation therapy followed by durvalumab in patients with operable rectal cancer. The enrollment period will be of 12 months. Eligible patients will be initiated to a standard concomitant chemoradiation therapy for 5 weeks. One week after the end of CT/RT patients will be treated with durvalumab for 3 administrations. Patient will undergo surgery after 10-12 weeks from the end of CT/RT and the surgical piece will be analyzed. After surgery…
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