Actively Recruiting
Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2026-02-17
42
Participants Needed
28
Research Sites
104 weeks
Total Duration
On this page
Sponsors
G
Gruppo Oncologico del Nord-Ovest
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic/locally advanced unresectable colorectal cancer
CONDITIONS
Official Title
Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Able and willing to comply with study treatments and follow-up at participating center
- Age 18 years or older at consent
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 3 months
- Histologically confirmed adenocarcinoma of colon or rectum, metastatic or unresectable locally advanced
- Willing to provide recent tumor tissue samples for analysis before treatment
- HER2 overexpression/amplification defined as IHC 3+ or 2+/ISH amplified per ASCO/CAP guidelines
- Known RAS and pMMR/MSS status by local testing
- Measurable disease by RECIST v1.1 imaging criteria
- Adequate blood counts, liver, kidney, heart, and coagulation function within 7 days before enrollment
- Completed required washout periods from previous treatments before screening
- Female participants of childbearing potential must have negative pregnancy tests and use effective contraception
- Male participants sexually active with female partners of childbearing potential must use condoms with spermicide and agree to contraception measures
- Agree to avoid breastfeeding during and for 7 months after treatment
You will not qualify if you...
- Previous systemic treatment for metastatic or unresectable colorectal cancer or participation in related clinical trials
- Spinal cord compression or active brain metastases needing treatment
- Prior treatment with anti-HER2 agents or topoisomerase I inhibitors
- Conditions affecting oral medication intake or absorption
- Significant cardiac or psychological conditions interfering with study participation
- Recent history of heart attack within 6 months or symptomatic heart failure
- Prolonged QT interval on ECG
- Uncontrolled high blood pressure
- History or current interstitial lung disease or pneumonitis requiring steroids
- Significant lung diseases or lung involvement by autoimmune disorders
- Complete lung removal or ongoing pleural, pericardial, or abdominal effusions needing drainage
- Unresolved toxicities from previous cancer therapies except stable chronic conditions
- Known allergies to study drugs or monoclonal antibodies
- Pregnant or breastfeeding women or patients planning pregnancy
- Other recent or concurrent cancers except certain treated skin or in-situ cancers
- Specific genetic polymorphisms affecting drug metabolism
- Recent major cardiac or bleeding events
- Recent major surgery or trauma
- Serious wounds or fractures not healing
- Organ transplant recipients
- Known HIV infection
- Active infections including tuberculosis, hepatitis B or C without proper control
- Recent live attenuated vaccine administration
- Psychiatric conditions preventing informed consent or trial compliance
- Use of disallowed medications
- Additional country-specific criteria for France and Germany regarding enzyme deficiencies and legal consent status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Hopital Prive Jean Mermoz
Lyon, France
Actively Recruiting
2
Hôpital La Timone - APHM
Marseille, France
Actively Recruiting
3
Hopital Saint Louis
Paris, France
Actively Recruiting
4
Centre Hospitalier Universitaire Reims
Reims, France
Actively Recruiting
5
Groupe Hospitalier Rance Emeraude
St-Malo, France
Actively Recruiting
6
Charite Universitaetsmedizin
Berlin, Germany
Actively Recruiting
7
Krankenhaus Nordwest
Frankfurt, Germany
Actively Recruiting
8
Istituto Tumori Bari Giovanni Paolo II
Bari, Bari, Italy, 70124
Actively Recruiting
9
A.O.U Careggi
Florence, Firenze, Italy, 50134
Actively Recruiting
10
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy, Italy, 20141
Actively Recruiting
11
Azienda Unita Sanitaria Locale Della Romagna
Ravenna, Italy, Italy, 48121
Actively Recruiting
12
Humanitas Mirasole S.p.A.
Rozzano, Italy, Italy, 20089
Actively Recruiting
13
Azienda Ospedaliera Card. G. Panico
Tricase, LE, Italy, 73039
Actively Recruiting
14
Fondazione IRCCS Istituto Nazionale dei Tumori - Milano
Milan, Milan, Italy, 20133
Actively Recruiting
15
Azienda Ospedaliero Universitaria di Modena
Modena, Missouri, Italy, 41124
Actively Recruiting
16
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy, 00168
Actively Recruiting
17
Policlinico Tor Vergata Roma
Roma, Roma, Italy, 00133
Actively Recruiting
18
IFO-Regina Elena Institute for Cancer Research
Roma, Roma, Italy, 00144
Actively Recruiting
19
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Udine, Italy, 33100
Actively Recruiting
20
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy, 80131
Actively Recruiting
21
IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale"
Naples, Italy, 80131
Actively Recruiting
22
Fondazione IRCCS Istituto Oncologico Veneto
Padova, Italy, 35128
Actively Recruiting
23
U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa
Pisa, Italy, 56126
Actively Recruiting
24
Hospital del Mar
Barcelona, Spain
Actively Recruiting
25
Hospital Universitario Virgen de las Nieves
Granada, Spain
Actively Recruiting
26
Hospital Universitario Fundación Jiménez
Madrid, Spain
Actively Recruiting
27
Hospital Clínico Universitario Santiago de Compostela
Santiago de Compostela, Spain
Actively Recruiting
28
Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
Research Team
F
Filippo Pietrantonio, MD
CONTACT
F
Federica M Palermo, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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