An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Trifluridine–tipiracil plus Bevacizumab Versus Trifluridine–tipiracil plus Bevacizumab Alone in Patients with Refractory Metastatic Colorectal Cancer with Liver Dominant Disease

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520356-24-00

Acronym

PHP-CRC-201

Enrollment

Registered

2025-07-08

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-11-21

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

Conditions

Refractory Metastatic Colorectal Cancer with Liver Dominant Disease

Brief summary

hPFS (time from randomization to the first occurrence of hepatic disease progression or death due to any cause)

Detailed description

Progression free survival (PFS), Objective response rate (ORR) (complete response [CR] + partial response [PR]), Hepatic ORR (hORR), Duration of response (DOR), Hepatic DOR (hDOR), Disease control rate (DCR), Hepatic DCR (hDCR), Overall survival (OS)

Interventions

DRUGMELPHALAN HIKMA 50 mg/10ml

DRUGpoudre et solvant pour solution injectable / pour perfusion

DRUGLonsurf 15 mg/6.14 mg film-coated tablets

DRUGZirabev 25 mg/ml concentrate for solution for infusion.

DRUGLonsurf 20 mg/8.19 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
hPFS (time from randomization to the first occurrence of hepatic disease progression or death due to any cause)	—

Secondary

Measure	Time frame
Progression free survival (PFS), Objective response rate (ORR) (complete response [CR] + partial response [PR]), Hepatic ORR (hORR), Duration of response (DOR), Hepatic DOR (hDOR), Disease control rate (DCR), Hepatic DCR (hDCR), Overall survival (OS)	—

Countries

Czechia, Germany, Italy, Netherlands, Spain

Outcome results

None listed

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