Study of bevacizumab and trifluridine combination given bi-weekly to reduce severe neutropenia in patients with metastatic colorectal cancer

2 1 1 1

What is this study about?

This clinical trial focuses on patients with metastatic colorectal adenocarcinoma, a type of cancer that has spread beyond the colon or rectum to other parts of the body. The study examines two medications: bevacizumab and trifluridine, which are used in combination to treat this type of cancer. The purpose of the study is to determine if giving these medications on a different schedule (every two weeks) can reduce the occurrence of severely low white blood cell counts (called neutropenia) compared to the standard treatment schedule.

The treatment involves receiving bevacizumab through an intravenous infusion (a drip into the vein) and taking trifluridine as oral tablets. Participants will be randomly assigned to receive either the standard treatment schedule or the new two-weekly schedule. The treatment period may last up to 24 months, during which patients will have regular check-ups to monitor their health and any side effects.

The study will track how often patients experience severe neutropenia with both treatment schedules. Other aspects being monitored include how long patients survive, whether their cancer responds to treatment, and how well patients tolerate the medications. This information will help determine if the new treatment schedule is safer and more effective than the current standard approach.

1 Initial assessment

A medical evaluation will be performed, including blood tests and tumor imaging (CT scan or MRI) to confirm eligibility

Blood tests will check liver function, kidney function, and blood cell counts

A pregnancy test will be required for women who can become pregnant

2 Treatment assignment

You will be randomly assigned to one of two treatment groups

Both groups will receive bevacizumab (given through an intravenous infusion) and trifluridine (taken as oral tablets)

The difference between groups is in how often the medication is given

3 Treatment period

Regular clinic visits will be required for treatment administration and monitoring

Blood tests will be performed to monitor blood cell counts and other health indicators

Imaging scans will be conducted to assess how the tumor responds to treatment

Side effects will be monitored, with special attention to reduced white blood cell counts (neutropenia)

4 Follow-up assessments

Regular health assessments will continue throughout the study period

Your physical condition will be monitored using a scale called ECOG PS

The study will track how long the treatment remains effective

The overall duration of the study is expected to continue until January 31, 2029

5 Safety monitoring

Any side effects will be recorded and evaluated

Treatment doses may be adjusted if necessary

You will be monitored for at least 6 months after completing the treatment

Who Can Join the Study?

Must be at least 18 years old
Must have signed and dated informed consent form
Must have a life expectancy of at least 3 months
Must be able to swallow tablets
Must have good blood cell counts:
– Sufficient white blood cells (neutrophils >1.5 x 109/L)
– Sufficient platelets (>100 x 109/L)
– Sufficient hemoglobin (≥9 g/dL)
Must have adequate kidney function:
– Good creatinine clearance (≥30 mL/min)
– Limited protein in urine (<2+ on dipstick test or ≤1g/24h)
Must have adequate liver function:
– Liver enzymes within acceptable limits
– Total bilirubin within normal range
– Sufficient albumin levels (≥25 g/L)
Must have confirmed stage IV colorectal adenocarcinoma
Must have good physical performance status (ECOG 0-1, meaning able to perform daily activities)
Must have previously received treatment with specific cancer medications including fluoropyrimidine, oxaliplatin, irinotecan, and targeted therapies
Must have at least one measurable tumor that can be evaluated by CT scan or MRI
Must have known tumor genetic status (BRAF, RAS, and MSI/dMMR status)
For women who can become pregnant:
– Must have negative pregnancy test
– Must use effective birth control during study and 6 months after
– Must not be pregnant or breastfeeding
For men who can father children:
– Must use effective birth control during study and 6 months after
Must be willing to attend all scheduled visits and follow study requirements
Must be registered with French National Health Care System or PUMA

Who Cannot Join the Study?

Age below 18 years or above 75 years
Known hypersensitivity (allergic reaction) to bevacizumab or trifluridine/tipiracil
Presence of active brain metastases (cancer spread to the brain)
Severe kidney dysfunction (poor kidney function)
Severe liver dysfunction (poor liver function)
Uncontrolled high blood pressure
Major surgery within the past 28 days
Active bleeding or high risk of bleeding
Pregnancy or breastfeeding
Serious heart conditions, including:
- Heart attack within the past 6 months
- Unstable angina (chest pain)
- Severe heart failure
Active infections requiring systemic treatment (medications that affect the whole body)
Other active cancers (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
Inability to swallow oral medications
Any condition that, in the opinion of the investigator, would interfere with the safe conduct of the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Prive Jean Mermoz	Lyon	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Institut Sainte Catherine	Avignon	France
Centre Francois Baclesse	Caen	France
Groupe Hospitalier Rance Emeraude	Saint-Malo	France
Cpskvh Hatpauxywls Eg Unmifzeluhkdb Dj Leomuml	Limoges	France
Bgrnbgae Unyywbenjd Hrpxobsh Cczduj	Besançon	France
Cvwqer Hnyhoajkejp Rxdtbkli Ugskscthctmrr Dr Tgsnb	Tours	France
Cjpxaf Lcxw Bhwvri	Lyon	France
Cuoxmk Hranvlgaogq Utigjndfghryn Rrdaw	Reims	France
Ibtwqwui Mzfrwkflvd Mmbwenfkpy	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.10.2025

Trial locations

Investigated drugs:

Bevacizumab is a medication used in cancer treatment that works by blocking the formation of new blood vessels that feed tumors. It helps to slow down or stop cancer growth by cutting off the tumor’s blood supply. This medication is commonly used in treating various types of cancer, including metastatic colorectal cancer.

Trifluridine/tipiracil is a combination medication used to treat advanced colorectal cancer. It works by interfering with cancer cell DNA and preventing cancer cells from growing and multiplying. This medication is typically used when other treatments have not been successful.

These medications are being studied together to see if changing how often they are given can reduce the side effect of neutropenia (a decrease in white blood cells that can increase the risk of infection) while maintaining their effectiveness in treating metastatic colorectal cancer.

Investigated diseases:

Colorectal adenocarcinoma

Colorectal Adenocarcinoma – A type of cancer that begins in the large intestine (colon) or rectum. It develops when cells in the inner lining of the colon or rectum start growing abnormally and form tumors. The disease typically starts as small, benign growths called polyps that can slowly develop into cancer over time. This cancer usually develops gradually, and early stages may not cause noticeable symptoms. As it progresses, it can spread through the layers of the intestinal wall and potentially to other parts of the body. The condition most commonly affects the cells that produce mucus and other fluids in the colon and rectum.

Trial ID:

2024-520128-27-00

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of bevacizumab and trifluridine combination given bi-weekly to reduce severe neutropenia in patients with metastatic colorectal cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?