Natural History, Treatment Patterns and RW Outcomes in mCRC patients
Research type
Research Study
Full title
Natural History, Treatment Patterns, and Real-World Clinical Outcomes in Patients with Unresectable Advanced or Metastatic Colorectal Cancer in Europe
IRAS ID
369716
Contact name
Francisca Elena Marti
Contact email
Sponsor organisation
GlaxoSmithKline,LLC
Duration of Study in the UK
0 years, 5 months, 16 days
Research summary
Colorectal cancer (CRC) is one of the most common cancers worldwide. In 2024, CRC represented over 12% of all new cancer diagnoses and cancer-related deaths in Europe. Approximately 15% of CRC patients present with locally advanced disease, some of whom are considered unresectable (i.e., cannot be removed by surgery), and 25% are metastatic at presentation (i.e., synchronous); around a quarter of CRC patients will develop metachronous metastasis following treatment.
Depending on the location, patients with unresectable advanced CRC can have an equally poor prognosis as metastatic CRC, which is associated with a 5-year survival of less than 20%. First-line therapy (1L) in unresectable advanced or metastatic CRC tends to consist of a fluoropyrimidine used in combination with irinotecan (FOLFIRI) or oxaliplatin (FOLFOX). Monoclonal antibodies, including bevacizumab, cetuximab, and panitumumab, may be used in combination with 1L chemotherapies to improve outcomes. Second-line therapy (2L) involves a switch from initial FOLFOX or FOLFIRI to the other and third-line (3L) relies on monoclonal antibodies, with new evidence emerging for multi-targeted kinase inhibitors.
GSK’227 is a B7-H3 targeted antibody-drug conjugate (ADC) that has been shown to have promising anti-tumor activity and a favorable safety profile in a Phase 1 study performed by Hansoh (in China). At the American Society of Clinical Oncology 2025 meeting, GlaxoSmithKline (GSK) presented plans for their global Phase 1 dose escalation/expansion study ARTEMIS-002 of GSK’227 for use in patients with advanced solid tumors, including gastrointestinal cancers. There is an ongoing need for safe and effective treatments for patients with unresectable advanced or metastatic CRC, a disease where treatment options can be quickly exhausted due to an aggressive trajectory.The aim of this natural history of disease study is to describe real-world clinical outcomes, patient characteristics, and treatment patterns for patients with unresectable advanced or metastatic CRC in the EU and UK.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
26/SC/0192
Date of REC Opinion
10 Jun 2026
REC opinion
Favourable Opinion