Phase II study of Durvalumab (MEDI4736) plus Total Neoadjuvant Therapy (TNT) in locally advanced rectal cancer (The DUREC trial)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515240-24-00

Acronym

ESR-17-13082

Enrollment

Registered

2024-11-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced rectal cancer

Brief summary

1) Pathological complete response (pCR) rate.

Detailed description

1) Tumor downstaging., 2) Tumor regression grade (TGR)., 3) R0 resection rate., 4) Clear circumferential resection margin (CRM) rate., 5) 3-year disease-free survival (DFS)., 6) Toxicity profile (short and long-term)., 7) Reduction of surgical complications., 8) Calculation of the neoadjuvant rectal (NAR) score

Interventions

DRUGCAPECITABINE

DRUGCALCIUM FOLINATE

DRUGFLUOROURACIL

DRUGDURVALUMAB

DRUGOXALIPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1) Pathological complete response (pCR) rate.	—

Secondary

Measure	Time frame
1) Tumor downstaging., 2) Tumor regression grade (TGR)., 3) R0 resection rate., 4) Clear circumferential resection margin (CRM) rate., 5) 3-year disease-free survival (DFS)., 6) Toxicity profile (short and long-term)., 7) Reduction of surgical complications., 8) Calculation of the neoadjuvant rectal (NAR) score	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026