Who is sponsoring NCT07213570?

NCT07213570 is sponsored by National Cancer Institute, Naples.

What condition does NCT07213570 study?

NCT07213570 studies Colorectal Cancer Metastatic.

What drugs are being tested in NCT07213570?

Interventions: standard second line treatment, at discretion of the investigator, Regorafenib (BAY73-4506).

What is the status of NCT07213570?

NCT07213570 is currently RECRUITING.

Last reviewed 2025-12-16 · How we verify

Regorafenib as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer: a Multicentre, Phase 2 Study

NCT07213570 Phase 2 RECRUITING

The investigators hypothesize that patients with mCRC RAS-mutant eligible for a second line treatment with good prognostic features, identified as single metastatic site, long progression free survival (PFS) in first line treatment, might benefit from a personalized approach, with less intensive treatment with regorafenib as part of a continuum-of-care strategy aimed at ensuring quality of life and extending survival.

Details

Lead sponsor	National Cancer Institute, Naples
Phase	Phase 2
Status	RECRUITING
Enrolment	60
Start date	2025-10-16
Completion	2027-04

Conditions

Colorectal Cancer Metastatic

Interventions

standard second line treatment, at discretion of the investigator
Regorafenib (BAY73-4506)

Primary outcomes

Progression Free Survival rate at 6 months in the two arms. — up to 6 months from randomization
Progression Free Survival rate at 6 months(PFS rate at 6-months) is defined as the rate of assessable patients alive and not progressed after 6 months from study initiation (i.e randomization) to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first.

Countries

Italy