Study of melphalan followed by trifluridine-tipiracil and bevacizumab combination versus trifluridine-tipiracil and bevacizumab in liver metastatic colorectal cancer

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What is this study about?

This study focuses on patients with Refractory Metastatic Colorectal Cancer where cancer has spread mainly to the liver. The study compares two treatment approaches. One group of patients will receive a combination of medications including Melphalan delivered directly to the liver, followed by treatment with Trifluridine-tipiracil and Bevacizumab. The other group will receive only Trifluridine-tipiracil and Bevacizumab without the liver-directed Melphalan treatment.

The main purpose of this research is to determine if adding Melphalan treatment to the liver before starting the combination of Trifluridine-tipiracil and Bevacizumab helps to better control cancer growth in the liver compared to using Trifluridine-tipiracil and Bevacizumab alone. Trifluridine-tipiracil is given as tablets by mouth, while Bevacizumab is given through an infusion into a vein.

Throughout the study, patients will have regular medical check-ups and imaging tests to monitor their cancer. These tests will help determine how well the treatment is working and track any changes in the cancer, both in the liver and elsewhere in the body. The study will continue until the cancer shows signs of growth or until other factors require stopping the treatment.

1 Initial randomization

You will be randomly assigned to one of two treatment groups:

Group 1: Melphalan/HDS treatment followed by Trifluridine-tipiracil plus Bevacizumab

Group 2: Trifluridine-tipiracil plus Bevacizumab alone

2 Medical imaging

You will undergo chest, abdomen, and pelvis CT scans

An MRI scan of your liver will be performed

These scans help monitor your condition throughout the treatment

3 Treatment administration

Group 1 patients receive:

– Melphalan through a special injection procedure into the liver

– After completion, treatment continues with Trifluridine-tipiracil tablets taken by mouth

– Bevacizumab given through an intravenous infusion

Group 2 patients receive:

– Trifluridine-tipiracil tablets taken by mouth

– Bevacizumab given through an intravenous infusion

4 Regular monitoring

Your liver condition will be regularly assessed

Regular scans will track any changes in tumor size

Your overall health status will be monitored throughout the study period

5 Study duration

The study continues until February 2027

Your participation duration depends on how your condition responds to treatment

Regular assessments will determine if the treatment should continue

Who Can Join the Study?

Must be 18 years or older at the time of giving consent
Women who can become pregnant must have a negative pregnancy test within 7 days before starting the study
Women who can become pregnant and men who are fertile must use effective birth control methods from the time of consent until at least 6 months after the last study treatment
Must provide signed informed consent
Must have confirmed colorectal cancer that has spread to the liver, with liver tumors taking up 50% or less of the liver
Must have cancer that is mainly in the liver that cannot be removed by surgery
Liver tumors must be measurable by CT scan or MRI
Must weigh at least 35 kg (77 pounds)
If cancer has spread outside the liver, it must be limited to:
- Up to 5 lung tumors no larger than 2 cm each
- Up to 5 lymph nodes no larger than 2 cm each
Must have recent scans (within 28 days) of chest, abdomen, and liver before starting the study
Must have previously received and either did not respond to or could not tolerate standard cancer treatments including chemotherapy and biological therapy
Must have good physical function ability (ECOG performance status of 0-1)

Who Cannot Join the Study?

Age below 18 years or above 75 years
Previous treatment with trifluridine-tipiracil (a type of chemotherapy medication)
Active brain metastases (cancer that has spread to the brain)
Known allergies to study medications
Severe heart conditions or uncontrolled high blood pressure
Significant liver dysfunction not related to cancer
Active bleeding or high risk of bleeding
Major surgery within 4 weeks before starting the study
Pregnant or breastfeeding women
Active infections requiring systemic treatment
Other active cancers (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
Psychiatric or other conditions that could interfere with the ability to provide informed consent
Life expectancy less than 3 months
Participation in another clinical trial within 30 days before starting this study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Lkhrd Ugwrgbbsjxbd Mowxquo Cquykka (qcjzn	Leiden	The Netherlands
Iiparkbq Cltmuy Dtqdxyyitmhsynskj	L'hospitalet De Llobregat	Spain
Hqeyup Pjtsezadhopus Lqjlrlk Gsxa	Leipzig	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	02.06.2025
Germany	Recruiting	02.06.2025
Italy	Recruiting	02.06.2025
Spain	Recruiting	02.06.2025
The Netherlands	Not yet recruiting	02.06.2025

Trial locations

Investigated drugs:

Melphalan is a chemotherapy medication used to treat various types of cancer. In this trial, it is delivered through a specialized system called HDS (Hepatic Delivery System) that targets the liver specifically. This method helps to deliver the medication directly to liver tumors while minimizing exposure to other parts of the body.

Trifluridine-tipiracil is an oral combination medication used to treat colorectal cancer. It works by interfering with cancer cell DNA, which helps stop or slow down the growth of cancer cells.

Bevacizumab is a targeted therapy that works by blocking the formation of new blood vessels that feed tumors. By reducing the blood supply to cancer cells, it can help slow down or stop tumor growth. It is given through an intravenous infusion and is commonly used in combination with other cancer treatments.

Investigated diseases:

Metastatic Colorectal Cancer with Liver Dominant Disease – A form of colorectal cancer that has spread beyond its original location in the colon or rectum, with the liver being the main site of cancer spread. The disease begins in the large intestine (colon) or rectum and develops secondary tumors primarily in the liver tissue. This condition occurs when cancer cells from the primary colorectal tumor travel through the bloodstream or lymphatic system and establish new growth in the liver. The liver becomes the predominant site of cancer activity, though other organs may also be affected to a lesser extent. The disease typically develops gradually, with the liver metastases growing over time and potentially affecting liver function.

Trial ID:

2024-520356-24-00

Protocol code:

PHP-CRC-201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of melphalan followed by trifluridine-tipiracil and bevacizumab combination versus trifluridine-tipiracil and bevacizumab in liver metastatic colorectal cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?