A randomized phase III trial assessing a regorafenib-irinotecan combination (REGIRI) versus regorafenib alone in metastatic colorectal cancer patients after failure of standard therapies, according to the A/A genotype of Cyclin D1.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512555-21-00

Acronym

PROICM 2018-01 NEX

Enrollment

Registered

2024-07-02

Start date

2019-09-18

Completion date

Unknown

Last updated

2025-10-29

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

Overall survival presented with its median and confidence interval at 95%, estimated from randomization date to the date of death, whatever the cause, using the Kaplan-Meier method.

Detailed description

Progression-free survival (PFS), Time to Deterioration, Disease control rate, Objective response rate, Safety according version 5 of NCI-CTCAE, Quality of life (EORTC QLQ-C30)

Interventions

DRUGIRINOTECAN

DRUGREGORAFENIB

DRUGStivarga 40 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival presented with its median and confidence interval at 95%, estimated from randomization date to the date of death, whatever the cause, using the Kaplan-Meier method.	—

Secondary

Measure	Time frame
Progression-free survival (PFS), Time to Deterioration, Disease control rate, Objective response rate, Safety according version 5 of NCI-CTCAE, Quality of life (EORTC QLQ-C30)	—

Countries

France

Outcome results

None listed

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