Objective Responsive Rate (ORR)Phase 2Liquid-DRER2NCT06314997
Dynamic Changes in Circulating Tumour Cells Protein Expression
A Phase 2 study testing panitumumab (EGFR inhibitors) in people with Objective Responsive Rate (ORR), run by Matteo's Friends at 1 site in Italy.
Trial summary
This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Objective Responsive Rate (ORR)
- What is being tested?
- panitumumab (EGFR inhibitors)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jan 2019to 18 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2 (scores range from 0 to 5, with higher numbers reflecting greater disability) ,
- medically able to receive chemotherapy.
Who cannot join
- evidence of infective disease before enrollment ,
- a history of another primary cancer within the previous 3 years,
- the presence of synchronous primary colorectal cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natalia Malara contact
About this study
Official title: Dynamic Changes in RAS Gene Status and HER2 Expression in Circulating Tumour Cells: a Phase II Trial
This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4).
Read the detailed description
The investigators enroll patients with histologically confirmed advanced stage (T3 or T4, N1/2, M0/1) colorectal adenocarcinoma with molecular analysis on RAS mutant status. The participants are enrolled within 3 weeks at the time of progression disease (PD) from any line of therapy. Blood samples were collected from each participant after obtaining informed consent. Permission to perform CTCs analysis from blood was obtained from the Regional Ethical Committee (No.2013/34) and the study is conducted in accordance with the Declaration of Helsinki.
- Conditions
- Objective Responsive Rate (ORR)
- Being tested
- panitumumab (EGFR inhibitors)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panitumumab (EGFR inhibitors)Drug
Chemotherapy treatment includes anti-EGFR biologics such as cetuximab or panitumumab, antiangiogenic drugs such as bevacizumab or aflibercept. The indication to treat depends from the presence of CTCs analysed for Ras mutation and HER2 expression
| Study group | Role | What they receive |
|---|---|---|
| RAS unmutated CTCs HER positive | Experimental | Not described Receives: Drug: panitumumab (EGFR inhibitors) |
| CTCs | Experimental | Not described Receives: Drug: panitumumab (EGFR inhibitors) |
| RAS unmutated CTCs HER negative | Experimental | Not described Receives: Drug: panitumumab (EGFR inhibitors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy end point was Objective Responsive Rate (ORR) at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start14 Jan 2019
- Primary completion17 Dec 2024
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Objective Responsive Rate (ORR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matteo's Friends
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314997
- Sponsor's protocol ID
- 2013.34
- Acronym
- Liquid-DRER2
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malara N, Donato G, Ferrazzo F, Garo NC, Fulciniti F. The Charactex Protocol for Blood-Derived Cytological Preparation of Nonhematological Cancer. Acta Cytol. 2023;67(3):295-303. doi: 10.1159/000527904. Epub 2022 Dec 12.
PubMed 36509041Malara N, Coluccio ML, Grillo F, Ferrazzo T, Garo NC, Donato G, Lavecchia A, Fulciniti F, Sapino A, Cascardi E, Pellegrini A, Foxi P, Furlanello C, Negri G, Fadda G, Capitanio A, Pullano S, Garo VM, Ferrazzo F, Lowe A, Torsello A, Candeloro P, Gentile F. Multicancer screening test based on the detection of circulating non haematological proliferating atypical cells. Mol Cancer. 2024 Feb 13;23(1):32. doi: 10.1186/s12943-024-01951-x.
PubMed 38350884Malara N, Trunzo V, Foresta U, Amodio N, De Vitis S, Roveda L, Fava M, Coluccio M, Macri R, Di Vito A, Costa N, Mignogna C, Britti D, Palma E, Mollace V. Ex-vivo characterization of circulating colon cancer cells distinguished in stem and differentiated subset provides useful biomarker for personalized metastatic risk assessment. J Transl Med. 2016 May 12;14(1):133. doi: 10.1186/s12967-016-0876-y.
PubMed 27176720
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in RAS Gene Status and HER2 Expression in Circulating Tumour Cells: a Phase II Trial
- ClinicalTrials.gov ID
- NCT06314997
- Acronym / sponsor ID
- Liquid-DRER2 / 2013.34
- Conditions
- Objective Responsive Rate (ORR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Matteo's FriendsUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4).
Detailed description
The investigators enroll patients with histologically confirmed advanced stage (T3 or T4, N1/2, M0/1) colorectal adenocarcinoma with molecular analysis on RAS mutant status. The participants are enrolled within 3 weeks at the time of progression disease (PD) from any line of therapy. Blood samples were collected from each participant after obtaining informed consent. Permission to perform CTCs analysis from blood was obtained from the Regional Ethical Committee (No.2013/34) and the study is conducted in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RAS unmutated CTCs HER positive | Experimental | Drug: panitumumab (EGFR inhibitors) |
| CTCs | Experimental | Drug: panitumumab (EGFR inhibitors) |
| RAS unmutated CTCs HER negative | Experimental | Drug: panitumumab (EGFR inhibitors) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2 (scores range from 0 to 5, with higher numbers reflecting greater disability) ,
- medically able to receive chemotherapy.
Key exclusion criteria (3 listed)
- evidence of infective disease before enrollment ,
- a history of another primary cancer within the previous 3 years,
- the presence of synchronous primary colorectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| panitumumab (EGFR inhibitors)Chemotherapy treatment includes anti-EGFR biologics such as cetuximab or panitumumab, antiangiogenic drugs such as bevacizumab or aflibercept. The indication to treat depends from the presence of CTCs analysed for Ras mutation and HER2 expression | Drug | CTCs, RAS unmutated CTCs HER negative, RAS unmutated CTCs HER positive |
Primary outcome
The primary efficacy end point was Objective Responsive Rate (ORR) at 12 months.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 36509041Malara N, Donato G, Ferrazzo F, Garo NC, Fulciniti F. The Charactex Protocol for Blood-Derived Cytological Preparation of Nonhematological Cancer. Acta Cytol. 2023;67(3):295-303. doi: 10.1159/000527904. Epub 2022 Dec 12.
- Background: PubMed 38350884Malara N, Coluccio ML, Grillo F, Ferrazzo T, Garo NC, Donato G, Lavecchia A, Fulciniti F, Sapino A, Cascardi E, Pellegrini A, Foxi P, Furlanello C, Negri G, Fadda G, Capitanio A, Pullano S, Garo VM, Ferrazzo F, Lowe A, Torsello A, Candeloro P, Gentile F. Multicancer screening test based on the detection of circulating non haematological proliferating atypical cells. Mol Cancer. 2024 Feb 13;23(1):32. doi: 10.1186/s12943-024-01951-x.
- Background: PubMed 27176720Malara N, Trunzo V, Foresta U, Amodio N, De Vitis S, Roveda L, Fava M, Coluccio M, Macri R, Di Vito A, Costa N, Mignogna C, Britti D, Palma E, Mollace V. Ex-vivo characterization of circulating colon cancer cells distinguished in stem and differentiated subset provides useful biomarker for personalized metastatic risk assessment. J Transl Med. 2016 May 12;14(1):133. doi: 10.1186/s12967-016-0876-y.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalia Malara contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing panitumumab (EGFR inhibitors) in people with Objective Responsive Rate (ORR), run by Matteo's Friends at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Malara, prof (03489705145, nataliamalara@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy end point was Objective Responsive Rate (ORR) at 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06314997, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.