Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Trastuzumab deruxtecan for Colorectal Cancer

This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.

Official registry: https://clinicaltrials.gov/study/NCT05845450 · Gruppo Oncologico del Nord-Ovest · enrollment listed as 197

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Trastuzumab deruxtecan, Durvalumab, or Panitumumab. The registry lists allocation as randomized. This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration.

They plan to enroll about 197 people at Milan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Window-of-opportunity Umbrella Platform Trial of Short-course Pre-operative Targeted Treatments in Patients With Molecularly Selected and Resectable Primary Colorectal Cancer: the UNICORN Study

Interventions: Trastuzumab deruxtecan, Durvalumab, Panitumumab, Botensilimab, Balstilimab, Sotorasib, Vorbipiprant, Nivolumab, Amivantamab, Botensilimab, Balstilimab

Primary outcome (registry wording): major pathological response rate

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • General who can join
  • ECOG PS of 0 and 1
  • Histologically confirmed colorectal cancer adenocarcinoma that is judged as initially resectable with elective surgery aimed at radical intent with R0 margins as per multidisciplinary team assessment
  • Radiological stage cT3-4, N0-2, M0 using computed tomography (CT) as in the pivotal FOxTROT study
  • Patients with rectal cancer candidate for R0 resection, not requiring pre-operative radiotherapy based on multidisciplinary team assessment, with the following characteristics on high-resolution thin slice (3 mm) contrast-enhanced magnetic resonance imaging (MRI):
  • ≤ T3a defined at the MRI (perivisceral fat infiltration \<2 mm) and clinical N0
  • Upper-medium, defined as tumors with distal margin ≥ 5 cm from the anal verge

Public study contact (from the registry)

Filippo Pietrantonio, MD

+39 0223903807

filippo.pietrantonio@istitutotumori.mi.it

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05845450 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05845450?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05845450?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary