RecruitingPhase 2NCT06242067

Second-line Treatment of Metastatic Colorectal Cancer

Irinotecan in Combination With Trifluridine-tipiracil and Bevacizumab in Pre-treated Metastatic Colorectal Cancer


Sponsor

Qilu Hospital of Shandong University

Enrollment

50 participants

Start Date

Apr 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this multicenter, single-arm, observational cohort study is to investigate the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based chemotherapy (including 5-FU/capecitabine/S-1) exposure in the metastatic setting or within 12 months of recurrence.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a second-line treatment approach for metastatic colorectal cancer — cancer of the colon or rectum that has spread to other organs — in patients whose cancer has progressed after initial (first-line) chemotherapy. The trial evaluates a treatment combination to see whether it can slow or reverse disease progression. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed metastatic or recurrent colorectal cancer (adenocarcinoma) - Your cancer progressed during or after first-line treatment that included 5-FU or capecitabine, oxaliplatin, and a targeted therapy (bevacizumab or cetuximab) - You have at least one measurable tumor on scans - Your general health status is good (ECOG 0–1) and your life expectancy is more than 3 months - Your blood counts, kidney, and liver function meet the required levels **You may NOT be eligible if...** - You have not received prior first-line chemotherapy - Your organ function does not meet the required levels - You are pregnant or not using adequate contraception - Your urine protein levels are too high Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrifluridine/tipiracil

patients received biweekly Trifluridine/tipiracil (30 mg/m2 twice daily; days 1-5), irinotecan (150 mg/m2; day 1) and bevacizumab (5 mg/kg; day 1).


Locations(1)

Qilu hospital of Shandong University

Jinan, Shandong, China

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NCT06242067


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