Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.

NCT03401294 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Saskatchewan

Phase

Phase 2

Started

2025-05-01

Last updated

2025-05-09

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

FOLFOXIRI and Bevacizumab →

FOLFOXIRI and Bevacizumab: Every 2 week for a total of 12 cycles

Study summary

Most patients with mCRC are treated with palliative chemotherapy and only a small number of patients with limited metastatic disease achieve long-term remission following metastasectomy. There is a growing need for more effective treatment in patients with liver-only mCRC to improve the rate of curative resection without compromising QOL.The current study is informed by our patient's needs. It aims to evaluate the rate of conversion therapy in patients with unresectable liver-only mCRC using the combination of FOLFOXIRI and bevacizumab and to assess the association between an early FDG-PT/CT response and other clinical and pathological biomarkers and hepatic metastasectomy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Adult patients, aged between 18 and 70 years with histologically proven adenocarcinoma or poorly differentiated carcinoma of the colon and rectum with unresectable liver-only metastases and no extra-hepatic disease. * World Health Organization (WHO) performance status of 0-1. * No previous chemotherapy for advanced disease. * Adequate functioning of the bone marrow, liver, and kidneys. Exclusion Criteria: * Breastfeeding or pregnancy. * An active second primary cancer with the exception of squamous cell carcinoma of the skin or an in situ cancer. * Severe or uncompensated concomitant medical conditions.

Primary outcome measure(s)

Rate of liver metastasectomy — Up to 3 years from the date of enrolment into the study
Conversion From Unresectable To Resectable Liver Metastases

Trial sites (1)

Facility	City	Region	Status
Allan Balir Cancer Center	Regina	Saskatchewan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03401294 on ClinicalTrials.gov ↗ ← All trials in Canada