Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

Sponsor
Federation Francophone de Cancerologie Digestive
Study ID
NCT07150403
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Carcinoma (mCRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin intravenous — DRUG
    85 mg/m² IV over 2 hours ; 1 cycle each 15 days
  • 5 FU bolus — DRUG
    5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous)
  • Folinic acid — DRUG
    400 mg/m² in intravenous
  • 5 FU continuous — DRUG
    2400 mg/m² intravenously over 46 hours
  • Irinotecan — DRUG
    180 mg/m² IV over 1h30
  • FRUQUINTINIB — DRUG
    5 mg capsule, taken orally, once daily for 3 weeks, followed by a 7-day break, then resumed (Day 1= Day 29).
  • BEVACIZUMAB — DRUG
    5 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

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Sep 2025
Primary completion
Feb 28, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm A FOLFOX/FOLFIRI + Fruquintinib
    FOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line); D1 = D15 + FRUQUINTINIB
  • Active Comparator: Control arm B FOLFOX/FOLFIRI + Bevacizumab
    FOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line); D1 = D15 + BEVACIZUMAB (D1 = D15)

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: at 4 months after the start of treatment ]

Central Contacts

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