A phase 1/2 study exploring the safety and activity of Trifluridine/Tipiracil in combination with Capecitabine and Bevacizumab in metastatic colorectal cancer patients. The TriComB trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513271-41-00

Acronym

TRICOMB

Enrollment

Registered

2024-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

metastatic colorectal cancer, colorectal metastatic cancer

Brief summary

Objective Response Rate (ORR) is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, determined by investigator reported measurements. According to RECIST 1.1 criteria and the non-randomised nature of the study, a confirmation of CR and PR is required.

Detailed description

Overall Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (version 5.0)., Progression Free Survival (PFS), Overall Survival (OS), The analysis of PROs endpoints

Interventions

DRUGBEVACIZUMAB

DRUGCAPECITABINE

DRUGLonsurf 15 mg/6.14 mg film-coated tablets

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
Objective Response Rate (ORR) is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, determined by investigator reported measurements. According to RECIST 1.1 criteria and the non-randomised nature of the study, a confirmation of CR and PR is required.	—

Secondary

Measure	Time frame
Overall Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (version 5.0)., Progression Free Survival (PFS), Overall Survival (OS), The analysis of PROs endpoints	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

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