RecruitingPhase 2NCT06425133

Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers

Impact of Regorafenib in Combination With Multimodal Metronomic Chemotherapy on Progression-free Survival Compared With Standard Regorafenib for the Treatment of Chemo-resistant Metastatic Colorectal Cancers

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

174 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal Cancer

Summary

The main objective is to evaluate the impact of a Regorafenib combined with metronomic chemotherapy (capecitabine and cyclophosphamide) and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer by assessing progression-free survival.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of regorafenib plus low-dose, multi-drug chemotherapy (a strategy called metronomic chemotherapy) can help control metastatic colorectal cancer that has stopped responding to standard treatments. **You may be eligible if...** - You are over 18 years old - You have metastatic colorectal cancer confirmed by biopsy - Your cancer has progressed after standard treatments (including 5-FU, irinotecan, oxaliplatin, and relevant targeted therapies) - You have measurable tumors on scans - You are in good overall health (performance status 0–1) - Your blood counts, liver, and kidney function are within acceptable levels - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an allergy to iodine contrast used in CT scans - Your organ function is significantly impaired - You have had recent major surgery or are on strong anticoagulants without adequate control 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

PROCEDUREBlood sample

Blood sample for plasma collection, Blood sample for ctDNA (circulating tumoral DNA) collection

OTHERQuality of life questionnaires

EORTC QLQ-C30 questionnaire (Quality of life questionnaire Cancer 30) CR29 questionnaire (Colo-rectal cancer 29) EQ-5D5L questionnaire (EuroQol-5 Dimensions, 5 levels): repeated measures at baseline, M2, M4, M6, M8, M10, M12 and during the end of treatment visit and during the follow-up

PROCEDUREBiopsy

Fresh tumor biopsy at baseline and week 8

DRUGRegorafenib

For the first cycle: Regorafenib will be administered according to the "REDOS" schedule: week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle.

COMBINATION_PRODUCTRegorafenib + metronomic chemotherapy

• Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity. For the first cycle: Regorafenib will be administered according to the "REDOS" schedule: week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle. * Metronomic chemotherapy will be administrated as following:Cyclophosphamide: 50 mg per os, daily, for 6 months,Capecitabine: 625mg/m²/orally twice daily, for 6 months. * Low-dose Aspirin: 75 mg orally, daily, until progression.