Investigate the efficacy and safety of a bio-marker driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518534-81-00

Acronym

CAPRI-2

Enrollment

200

Registered

2024-12-09

Start date

2021-07-01

Completion date

Unknown

Last updated

2025-08-28

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

Conditions

metastatic colorectal cancer

Brief summary

Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRC.

Detailed description

Progression Free Survival (PFS): measured from the start of therapy until the first observation of disease progression or death due to any cause., Overall Survival (OS): calculated from the start of the study treatment until death., Safety: Adverse events graded according NCI CTCAE v 5.0., Molecular profiles of tumor tissue and liquid biopsy: molecular analysis of formalin fixed paraffin embedded (FFPE) tumor tissue, which is representative of the primary tumor or of a metastatic site at the diagnosis of mCRC, will be performed before the first line, whilst blood samples for liquid biopsy will be collected before each line of treatment.

Interventions

DRUGLonsurf 15 mg/6.14 mg film-coated tablets

DRUGFLUOROURACIL SODIUM

DRUGOXALIPLATIN

DRUGREGORAFENIB

DRUGBEVACIZUMAB

DRUGCETUXIMAB

DRUGCALCIUM LEVOFOLINATE

DRUGIRINOTECAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRC.	—

Secondary

Measure	Time frame
Progression Free Survival (PFS): measured from the start of therapy until the first observation of disease progression or death due to any cause., Overall Survival (OS): calculated from the start of the study treatment until death., Safety: Adverse events graded according NCI CTCAE v 5.0., Molecular profiles of tumor tissue and liquid biopsy: molecular analysis of formalin fixed paraffin embedded (FFPE) tumor tissue, which is representative of the primary tumor or of a metastatic site at the diagnosis of mCRC, will be performed before the first line, whilst blood samples for liquid biopsy will be collected before each line of treatment.	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026