An open-label, randomised, phase III study comparing trifluridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in first-line treatment of patients with metastatic colorectal cancer who are not candidate for intensive therapy (SOLSTICE study).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516180-85-00

Acronym

CL3-95005-006

Enrollment

Registered

2024-10-15

Start date

2019-04-15

Completion date

Unknown

Last updated

2025-09-29

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

Progression-free survival (PFS) based on investigator judgement

Detailed description

Overall survival (OS), Overall response rate (ORR), Disease control rate (DCR), Duration of response (DoR), Time to treatment failure (TTF), Safety and tolerability assessed by incidence of adverse events (AE), laboratory tests, physical examination and performance status (ECOG), vital signs, 12-leads ECG parameters, Quality of life (QoL)

Interventions

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

DRUGLonsurf 20 mg/8.19 mg film-coated tablets

DRUGLonsurf 15 mg/6.14 mg film-coated tablets

DRUGXeloda 150 mg film-coated tablets

DRUGXeloda 500 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) based on investigator judgement	—

Secondary

Measure	Time frame
Overall survival (OS), Overall response rate (ORR), Disease control rate (DCR), Duration of response (DoR), Time to treatment failure (TTF), Safety and tolerability assessed by incidence of adverse events (AE), laboratory tests, physical examination and performance status (ECOG), vital signs, 12-leads ECG parameters, Quality of life (QoL)	—

Countries

Denmark, Poland, Slovakia, Sweden

Outcome results

None listed

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