Study of FOLFOX or FOLFIRI chemotherapy with fruquintinib or bevacizumab as second-line treatment for patients with metastatic colorectal cancer

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What is this study about?

This study focuses on treating metastatic colorectal cancer, a condition where cancer that started in the colon or rectum has spread to other parts of the body. The study compares two different treatment combinations for patients who have already received one previous treatment. One group will receive FOLFOX or FOLFIRI chemotherapy combined with Fruquintinib (also known as FRUZAQLA), while the other group will receive the same chemotherapy combined with Bevacizumab (also known as Avastin).

The purpose of this study is to evaluate how well these treatment combinations control the disease after 4 months of treatment. FOLFOX chemotherapy includes the drugs fluorouracil, folinic acid, and oxaliplatin, while FOLFIRI chemotherapy includes fluorouracil, folinic acid, and irinotecan. Fruquintinib is taken as capsules by mouth, while the other medications are given through an intravenous infusion into a vein.

The treatment will continue for up to 12 months, with regular medical check-ups and imaging scans to monitor how the cancer responds to treatment. Throughout the study, doctors will track any side effects and how well patients tolerate the treatments. They will also monitor patients’ overall health status and quality of life using questionnaires.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups. Both groups receive standard chemotherapy (FOLFOX or FOLFIRI) combined with either fruquintinib or bevacizumab.

Before starting treatment, you will complete a quality of life questionnaire (EORTC QLQ-C30).

2 Treatment administration

If assigned to the fruquintinib group, you will receive hard capsules for oral use along with chemotherapy through intravenous infusion.

If assigned to the bevacizumab group, you will receive the medication through intravenous infusion along with chemotherapy.

Your physical condition will be assessed before each treatment cycle.

3 Regular monitoring

Your response to treatment will be evaluated through imaging scans at regular intervals.

Quality of life questionnaires will be completed every 2 months.

Side effects will be monitored and recorded for up to 30 days after the last treatment dose.

4 Four-month evaluation

A major assessment will occur 4 months after starting treatment to evaluate how well the treatment is controlling the disease.

This evaluation will include imaging scans to measure tumor response.

5 Ongoing treatment period

Treatment will continue as long as it remains beneficial and tolerable.

Regular assessments will continue to monitor disease status and side effects.

Treatment may be adjusted or discontinued based on how your body responds.

6 Follow-up period

After completing treatment, you will continue to be monitored for disease progression.

Follow-up visits will include health assessments and imaging scans.

Quality of life assessments will continue during this period.

Who Can Join the Study?

  • Age between 18 and 80 years old (for patients 75 or older, a special geriatric assessment score must be above 14)
  • Must have received previous treatment with specific medications (Bevacizumab or EGFRi, combined with FOLFOX or FOLFIRI) for colorectal cancer that has spread
  • Must have cancer that cannot be surgically removed
  • Must have at least one tumor that can be measured through imaging
  • Cancer spread (metastases) that cannot be treated with surgery, heat treatment, or targeted radiation
  • Must be able to perform daily activities with minimal assistance (WHO performance status 0 or 1)
  • Must have normal liver function tests
  • Must have a specific genetic type of tumor (BRAF V600E wild type)
  • Must have adequate blood counts:
    – Hemoglobin level at least 10 g/dL
    – Platelet count at least 100,000 per microliter
    – White blood cell count at least 1,500 per microliter
  • Must have adequate kidney function
  • Must have protein in urine below certain levels
  • Life expectancy of at least 3 months
  • Must agree to use effective birth control during the study and for:
    – Women: 15 months after treatment ends
    – Men: 12 months after treatment ends
  • Must be able to understand and sign informed consent documents
  • Must have health insurance or social security coverage
  • Must have available tumor tissue sample for testing
  • Must have confirmed diagnosis of colorectal cancer that has spread, with evidence of disease progression on imaging scans

Who Cannot Join the Study?

  • Having brain metastases (cancer that has spread to the brain) that are not treated or stable
  • Previous treatment with immune checkpoint inhibitors (a type of immunotherapy drug)
  • Active or chronic autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Severe heart conditions including heart failure or uncontrolled high blood pressure
  • Active infections requiring systemic treatment, including hepatitis B, hepatitis C, or HIV
  • Other active cancers requiring treatment (except for treated non-melanoma skin cancer or cervical cancer in situ)
  • Severe liver problems or cirrhosis (scarring of the liver)
  • Severe kidney disease requiring dialysis
  • Bone marrow problems causing low blood cell counts
  • History of organ transplant requiring immunosuppressive medications
  • Pregnant or breastfeeding women
  • Unable to give informed consent
  • Participation in another clinical trial within the last 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hôpital Privé du Confluent Nantes France
Clinique de Flandre Coudekerque Branche France
Hôpital Européen Georges-Pompidou Paris France
Aix Marseille University Marseille France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre De Cancerologue Du Grand Montpellier Montpellier France
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Institut Godinot Reims France
Clinique Tivoli Ducos Bordeaux France
IHFB Cognacq Jay Levallois-Perret France
Chorale Du Centre Hospitalier De Lens Lens France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier De Cholet Cholet France
Centre Hospitalier D Auxerre Auxerre France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
Institut De Cancerologie De Bourgogne Dijon France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Groupe Hospitalier Rance Emeraude Saint-Malo France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
Clinique Mutualiste de l’Estuaire St Nazaire France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
31.10.2025

Trial locations

FOLFOX is a combination chemotherapy treatment that includes different medications working together to fight cancer cells. It is commonly used to treat colorectal cancer.

FOLFIRI is another combination chemotherapy treatment used to treat colorectal cancer. Like FOLFOX, it combines different medications that work in different ways to fight cancer cells.

Fruquintinib is a targeted therapy medication that works by blocking the formation of new blood vessels that feed cancer cells, helping to slow or stop tumor growth.

Bevacizumab is a targeted therapy medication that also works by preventing the formation of new blood vessels that supply tumors with nutrients and oxygen. It is often used in combination with other cancer treatments to improve their effectiveness.

Metastatic Colorectal Cancer – A condition that begins as cancer in the colon or rectum and spreads to other parts of the body. It develops when abnormal cells in the large intestine grow uncontrollably and form tumors that can break away and travel through the bloodstream or lymphatic system to other organs. The cancer typically starts as small growths called polyps on the inner lining of the colon or rectum. As the disease progresses, cancer cells can spread (metastasize) most commonly to the liver, lungs, or distant lymph nodes. The condition can affect both the body’s digestive function and the function of organs where the cancer spreads.

Trial ID:
2025-522108-26-00
Trial Phase:
Therapeutic exploratory (Phase II)

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