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Study on Preventing Blood Clots with Tinzaparin in Patients with Metastatic Colorectal Cancer Starting First-Line Treatment

Verified siteRegistered drugNo placebo
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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 patients with metastatic colorectal cancer, which is an advanced form of cancer that starts in the colon or rectum and spreads to other parts of the body. The study is investigating the use of a medication called tinzaparin sodium, which is an antithrombotic agent. This means it helps prevent blood clots. The medication is given as a solution for injection, specifically through a subcutaneous injection, which is an injection under the skin.

The purpose of the study is to evaluate the effectiveness of using tinzaparin sodium for four months to prevent blood clots in patients with metastatic colorectal cancer who are starting their first line of treatment. This treatment may include chemotherapy, targeted therapy, or immunotherapy. The study will monitor patients for any blood clot events, whether they show symptoms or are found incidentally, during this period.

Participants in the study will receive either the medication or a placebo, and their health will be closely monitored throughout the trial. The study aims to gather information on how well the medication works in preventing blood clots in this specific group of patients. The trial is expected to continue until April 2025, providing valuable insights into the management of blood clots in patients with metastatic colorectal cancer.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written informed consent.

    Eligibility is confirmed for patients aged 18 or older with a diagnosis of stage IV colon or rectal adenocarcinoma.

    Patients must have genomic alterations assessed and be starting their first line of treatment for metastatic disease.

  2. Step 2

    Treatment initiation

    The patient begins the first line of systemic treatment, which may include chemotherapy, targeted therapy, or immunotherapy.

    The treatment plan is determined based on the patient's specific medical condition and genomic profile.

  3. Step 3

    Prophylaxis with tinzaparin

    The patient receives prophylaxis with tinzaparin sodium to prevent venous thromboembolic events.

    Tinzaparin is administered as a subcutaneous injection.

    The dosage is either 8,000 UI anti-Xa/0.4 ml or 4,500 UI anti-Xa/0.45 ml, depending on the specific prescription.

    The prophylaxis lasts for a duration of four months.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, the patient is monitored for any symptoms or incidents of venous thromboembolic events.

    The primary focus is on the prevention of events such as pulmonary thromboembolism, deep vein thromboembolism, and other related conditions.

    Regular assessments are conducted to evaluate the efficacy of the prophylaxis.

  5. Step 5

    Completion of trial

    The trial is estimated to conclude by April 23, 2025.

    Upon completion, the patient's health and any outcomes related to the prophylaxis are thoroughly reviewed.

Who can join the trial?

7 criteria

  • Must be a male or female who is at least 18 years old.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Must have a confirmed diagnosis of stage IV colon or rectal adenocarcinoma. This is a type of cancer that starts in the colon or rectum and has spread to other parts of the body.
  • Must have information about specific genetic changes, called BRAF and RAS genomic alterations, available during the screening process.
  • Must be starting the first line of treatment for cancer that has spread, using chemotherapy (a type of cancer treatment) with or without additional treatments like targeted therapy (treatments that target specific cancer cells) or immunotherapy (treatments that help the immune system fight cancer).
  • Must have an ECOG performance status of 0-2. This is a scale used to assess how well a person can perform daily activities, with 0 being fully active and 2 indicating some limitations but still able to care for oneself.
  • Must have a life expectancy of more than 6 months.

Who cannot join the trial?

8 criteria

  • Patients who do not have Stage IV colon or rectal adenocarcinoma. This is a type of advanced cancer that starts in the colon or rectum.
  • Patients who are not starting their first line of systemic treatment. This means treatments that affect the whole body, like chemotherapy.
  • Patients who are not eligible for prophylaxis with LMWH (tinzaparin). This is a medication used to prevent blood clots.
  • Patients who are not at risk of symptomatic or incidental VTE events. VTE stands for venous thromboembolism, which is a condition where blood clots form in the veins.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Tinzaparin is a medication used in this clinical trial to prevent blood clots in patients with metastatic colorectal cancer. It is a type of low molecular weight heparin (LMWH) that helps reduce the risk of venous thromboembolic events, which are blood clots that can occur in the veins. The trial aims to assess the effectiveness of using tinzaparin for four months to prevent these clots in patients starting their first line of cancer treatment.

What is already known about the treatment

Tinzaparin – Tinzaparin is administered as an injection under the skin, typically in the abdomen or thigh. It is currently used in medicine to prevent blood clots, particularly in patients with advanced colorectal cancer undergoing treatment. The main therapeutic indication for tinzaparin is the prevention of venous thromboembolic events, which are blood clots that can occur in veins. At the molecular level, tinzaparin works by enhancing the activity of antithrombin, a protein in the blood that inhibits clotting factors, thus reducing the formation of clots. It is classified as a low molecular weight heparin, a type of anticoagulant medication.

Investigated diseases

  • Stage IV Colon or Rectal Adenocarcinoma

    This is an advanced form of cancer that originates in the colon or rectum and has spread to other parts of the body. It typically begins as a growth called a polyp on the inner lining of the colon or rectum, which can become cancerous over time. In stage IV, the cancer has metastasized, meaning it has spread beyond the original site to distant organs such as the liver or lungs. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression. Management focuses on controlling the spread and alleviating symptoms.

  • Venous Thromboembolism (VTE)

    This condition involves the formation of blood clots in the veins, which can lead to serious complications if not managed. It includes deep vein thrombosis (DVT), where clots form in deep veins, usually in the legs, and pulmonary embolism (PE), where a clot travels to the lungs. Symptoms of DVT may include swelling, pain, and redness in the affected limb, while PE can cause shortness of breath, chest pain, and coughing. VTE can occur incidentally or be symptomatic, and it may be associated with certain risk factors such as cancer, surgery, or prolonged immobility. The condition can progress if clots dislodge and travel to vital organs, necessitating careful monitoring and management.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508860-31-00Protocol codeGIT-PRo-2022-02Estimated enrolment631 patientsSponsorGrupo Gallego De Investigacion En Tumores Digestivos

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