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Study on Regorafenib for Patients with Advanced RAS-Mutant Colorectal Cancer Using Regorafenib and Drug Combination

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called metastatic colorectal cancer that has a specific genetic change known as RAS mutation. The study is looking at how effective a medication called regorafenib is when used as a second treatment option for patients with this type of cancer. Regorafenib is taken in the form of a tablet. The purpose of the study is to see how well regorafenib works in stopping the cancer from getting worse over a period of six months.

During the study, participants will receive regorafenib and may also receive other treatments that are commonly used for this type of cancer. These treatments include medications like aflibercept, capecitabine, fluorouracil, bevacizumab, irinotecan hydrochloride trihydrate, oxaliplatin, and calcium levofolinate. Some of these medications are given through an IV infusion, which means they are delivered directly into the bloodstream through a vein, while others are taken orally as tablets.

The study will take place over a period of time, and participants will be monitored to see how their cancer responds to the treatment. The main goal is to determine if regorafenib can help control the cancer and improve the quality of life for patients. Participants will be regularly checked by healthcare professionals to track their progress and any side effects they may experience. The study aims to provide valuable information that could help improve treatment options for people with metastatic colorectal cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent to participate in the study procedures. This consent ensures that you understand the study and agree to take part in it.
Step 2
Initial assessments
You will undergo initial assessments to confirm eligibility. These assessments include checking your blood counts, liver function, kidney function, and electrolyte levels to ensure they are within normal ranges.
Your dihydropyrimidine dehydrogenase (DPYD) activity will be checked, and additional analysis of certain enzyme polymorphisms is recommended.
You must have a histologically proven diagnosis of colorectal adenocarcinoma and a RAS mutation confirmed at initial diagnosis.
Step 3
Treatment initiation
The treatment involves taking regorafenib as a second-line treatment. Regorafenib is administered in the form of Stivarga 40 mg film-coated tablets taken orally.
The dosage and frequency of regorafenib will be determined by the study protocol and your healthcare provider.
Step 4
Ongoing assessments
Throughout the study, your health and response to the treatment will be monitored regularly. This includes imaging tests to document measurable disease according to specific criteria.
Your quality of life will be assessed using specific questionnaires every 8 weeks until disease progression, treatment failure, or death.
Step 5
End of study participation
Your participation in the study will continue until the study's estimated end date or until you experience disease progression, treatment failure, or choose to withdraw from the study.
The study aims to assess the progression-free survival rate at 6 months and other outcomes related to your health and quality of life.

Who can join the trial?

14 criteria

Must provide written informed consent to participate in the study and related procedures.
Must have adequate bone marrow function: enough white blood cells (absolute neutrophil count ≥ 1.5 x 10⁹/L), enough platelets (platelet count ≥ 100 x 10⁹/L), and enough red blood cells (hemoglobin ≥ 9 g/dL).
Must have adequate liver function: total bilirubin ≤ 1.5 times the normal limit (or ≤ 2 if a biliary stent is present) and liver enzymes (AST/ALT) ≤ 5 times the normal limit.
Must have adequate kidney function: serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min for males and ≥ 50 mL/min for females.
Must have normal levels of electrolytes such as magnesium, calcium, sodium, and potassium.
Must have known activity of the enzyme dihydropyrimidine dehydrogenase (DPYD). Testing for another enzyme, UGT1A1, is recommended but not required.
Must be aged 18 or older.
Must have a confirmed diagnosis of colorectal adenocarcinoma.
Must have a diagnosis of metastatic disease.
Must have a RAS mutation at initial diagnosis, confirmed by a validated method, and known MMR/MSI status.
Must have achieved a progression-free survival (PFS) of more than 6 months with first-line chemotherapy combined with antiangiogenic treatment, or have only one metastatic site at study entry.
Must have an ECOG Performance Status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have measurable disease as shown by imaging, according to RECIST 1.1 criteria.
Must have an estimated life expectancy of more than 12 weeks.

Who cannot join the trial?

4 criteria

Patients who do not have metastatic colorectal cancer (mCRC) RAS-mutant cannot participate. Metastatic colorectal cancer means that the cancer has spread from the colon or rectum to other parts of the body. RAS-mutant refers to a specific genetic change in the cancer cells.
Patients who are not eligible for a second line treatment cannot participate. Second line treatment is the next treatment given when the first treatment doesn't work or stops working.
Patients who do not have good prognostic features cannot participate. Good prognostic features mean that the patient has certain health characteristics that suggest a better chance of responding well to treatment.
Patients who are not expected to have a progression-free survival rate at 6 months cannot participate. Progression-free survival means the length of time during and after treatment that the patient lives with the disease without it getting worse.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie
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Pozzuoli, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
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Naples, Italy
Casa Sollievo Della Sofferenza
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San Giovanni Rotondo, Italy

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Investigated drugs

Regorafenib is a medication used in this clinical trial to treat patients with advanced colorectal cancer that has a specific genetic mutation known as RAS-mutant. It is being tested as a second-line treatment, which means it is given to patients who have already tried another treatment that did not work well enough. The main goal of using regorafenib in this study is to see if it can help stop the cancer from getting worse for at least six months. Regorafenib works by blocking certain proteins that cancer cells need to grow, which may help slow down or stop the progression of the disease.

What is already known about the treatment

Regorafenib – Regorafenib is taken orally in the form of a tablet and is currently being studied as a second-line treatment for patients with advanced colorectal cancer that has spread to other parts of the body and has a specific genetic mutation known as RAS-mutant. In medical literature, it is recognized for its potential to improve the time patients live without their cancer getting worse. The main use of regorafenib is to treat certain types of cancer, including colorectal cancer, by blocking proteins that promote cancer cell growth. At the molecular level, it works by inhibiting multiple enzymes that are involved in the growth of cancer cells and the formation of blood vessels that supply tumors. Regorafenib is classified as a multi-kinase inhibitor, which means it targets several pathways that cancer cells use to grow and spread.

Investigated diseases

Metastatic Colorectal Cancer (mCRC) RAS-mutant – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and has spread to other parts of the body. The RAS-mutant form refers to a specific genetic mutation in the RAS gene, which can affect how the cancer grows and spreads. This mutation can lead to uncontrolled cell division and tumor growth. As the disease progresses, cancer cells can invade nearby tissues and organs, and may also spread to distant sites such as the liver or lungs. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower progression. The presence of the RAS mutation can influence the behavior of the cancer and its response to certain treatments.