The standard second-line treatment for metastatic colorectal cancer (mCRC) involves chemotherapy (FOLFOX or FOLFIRI) combined with an antiangiogenic agent, such as bevacizumab or aflibercept. Maintaining VEGF inhibition between first and second-line treatments has shown modest clinical benefits, with exploratory analyses suggesting that bevacizumab is more effective in smaller tumors. The ULYSSE trial aims to evaluate the efficacy and safety of Fruquintinib, a potent antiangiogenic agent, combined with a doublet chemotherapy (FOLFOX or FOLFIRI) in second-line treatment for BRAF wild-type, MSS mCRC patients who have failed prior treatment.
- Age ≥ 18 years and ≤ 80 years; provided the score of the G8 geriatric questionnaire is >14 for patients 75 years or older
Patients with a histologically confirmed diagnosis of metastatic colorectal cancer (mCRC), with a documented disease progression (as per RECIST v1.1, assessed by the investigator and confirmed through CT or MRI).
Patients must have previously received first-line therapy with Bevacizumab or an EGFRi, in combination with either FOLFOX or FOLFIRI, for non-resectable mCRC. Patients who progressed during the adjuvant chemotherapy (FOLFOX) or within the 6 months following its completion are eligible for inclusion
Patients must have an unresectable tumor at the time of enrollment.
- Patients who have received more than one prior systemic therapy
FOLFIRINOX Regimen +/- targeted therapy in the first line setting
Unknown RAS status
BRAF V600E mutated tumor
Parallel
Oxaliplatin intravenous
Drug85 mg/m² IV over 2 hours ; 1 cycle each 15 days
5 FU bolus
Drug5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous)
Folinic acid
Drug400 mg/m² in intravenous
5 FU continuous
Drug2400 mg/m² intravenously over 46 hours
Irinotecan
Drug180 mg/m² IV over 1h30
FRUQUINTINIB
Drug5 mg capsule, taken orally, once daily for 3 weeks, followed by a 7-day break, then resumed (Day 1= Day 29).
BEVACIZUMAB
Drug5 mg/kg over 90 minutes for the 1st course and in case of good tolerance the 2nd course should be administered over 60 minutes. The next courses should be administered in 30 minutes in case of good tolerance during the 2nd course
Disease Control Rate (DCR)
the percentage of patients with a complete response, a partial response or a stable disease at 4 months after the start of treatment.
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