Dynamic Changes in Circulating Tumour Cells Protein Expression

Dynamic Changes in RAS Gene Status and HER2 Expression in Circulating Tumour Cells: a Phase II Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06314997

Acronym

Liquid-DRER2

Enrollment

150

Registered

2024-03-18

Start date

2019-01-14

Completion date

2027-12-18

Last updated

2026-06-10

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

Conditions

Objective Responsive Rate (ORR)

Brief 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 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.

Interventions

DRUGpanitumumab (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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* evidence of infective disease before enrollment , * a history of another primary cancer within the previous 3 years, * the presence of synchronous primary colorectal cancer.

Design outcomes

Primary

Measure	Time frame
The primary efficacy end point was Objective Responsive Rate (ORR) at 12 months.	12 months

Countries

Italy

Contacts

CONTACTNatalia Malara, prof

nataliamalara@unicz.it03489705145

CONTACTNatalia Malara

nataliamalara@unicz.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026