Actively Recruiting
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2026-03-12
197
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent.
- Age 18 years or older.
- ECOG performance status 0 or 1.
- Histologically confirmed colorectal adenocarcinoma judged resectable with intent for complete removal.
- Radiological stage cT3-4, N0-2, M0.
- For rectal cancer, candidates for surgery without needing pre-operative radiotherapy, with tumors meeting specific MRI criteria.
- Availability of archival tumor tissue for molecular pre-screening.
- Presence of one selected molecular alteration for matching treatment.
- No prior systemic or neoadjuvant radiation therapy for colorectal cancer.
- Adequate bone marrow, renal, and liver function.
- Negative pregnancy test for women of childbearing potential.
- Willingness to use effective contraception during and after the trial.
- Ability to comply with study visits and procedures.
You will not qualify if you...
- Presence of distant metastases.
- Risk of obstructing disease.
- Need for neoadjuvant radiation or chemoradiation.
- Known allergy to assigned study drug or similar drugs.
- Other cancers within 2 years.
- Significant heart diseases including recent heart attack or symptomatic heart failure.
- Known HIV infection.
- Active infections including tuberculosis, hepatitis B or C unless adequately controlled.
- Severe acute or chronic illnesses affecting study participation.
- Psychiatric conditions limiting informed consent or compliance.
- Pregnancy or breastfeeding.
- Use of disallowed drugs.
- Specific exclusions per treatment cohort, such as prior related drug treatments, lung diseases, autoimmune conditions, magnesium or swallowing issues, and other medical conditions as detailed in the protocol.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Lombardia/MI, Italy, 20133
Actively Recruiting
Research Team
F
Filippo Pietrantonio, MD
CONTACT
F
Federica Palermo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
13
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