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Study on the Effect of Tinzaparin Sodium on Survival in Patients with Advanced Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called tinzaparin sodium on patients with advanced pancreatic cancer. Pancreatic cancer is a serious condition where cancer cells form in the tissues of the pancreas, an organ that helps with digestion and blood sugar regulation. The treatment being tested is a type of medication known as a low molecular weight heparin, which is used to prevent blood clots. The study aims to see if using tinzaparin sodium can help improve the time patients live without their cancer getting worse, known as progression-free survival.

Participants in the study will receive tinzaparin sodium through injections. The study will compare the outcomes of patients receiving this treatment with those who do not, to understand its effectiveness in preventing blood clots during cancer treatment. The study will also monitor any side effects, such as bleeding, and assess the overall survival of patients receiving the treatment. The goal is to determine if tinzaparin sodium can be a beneficial addition to the standard chemotherapy regimen for pancreatic cancer.

The study will take place over a period of time, with regular check-ups to monitor the health and progress of the participants. The results will help researchers understand if tinzaparin sodium can improve the quality of life and survival rates for patients with advanced pancreatic cancer. This research is important for developing better treatment strategies for this challenging disease.

1 joining the study

Participation begins after meeting specific criteria, including a confirmed diagnosis of locally advanced or metastatic pancreatic cancer, being 18 years or older, and planning to start first-line chemotherapy with NabG.

A written informed consent is required to proceed.

2 treatment initiation

The study involves the administration of tinzaparin sodium, a medication used to prevent blood clots.

The medication is provided as a solution for injection in pre-filled syringes, administered subcutaneously (under the skin).

The dosage options include 10,000 anti Xa IU/0.5mL, 18,000 anti Xa IU/0.9mL, and 14,000 anti Xa IU/0.7mL, depending on the specific requirements of the treatment plan.

3 ongoing treatment and monitoring

The primary goal is to evaluate the impact of preventing venous thromboembolism (VTE) on progression-free survival.

The study also investigates the effectiveness of long-term VTE prevention while receiving chemotherapy.

Regular monitoring for any VTE events, including deep vein thrombosis or pulmonary embolism, is conducted.

4 evaluation of outcomes

The primary outcomes include progression-free survival and the occurrence of VTE events.

Secondary outcomes involve the percentage of patients experiencing bleeding events, overall response rate, quality of life changes, and overall survival.

The study is expected to conclude by August 2025.

Who Can Join the Study?

  • The patient must have locally advanced or metastatic pancreatic cancer. This means the cancer is either in the pancreas and nearby areas or has spread to other parts of the body. This must be confirmed by recommended tests.
  • The patient must be 18 years or older.
  • The patient should be planning to start 1st line chemotherapy with a drug called NabG. This is the first treatment given for cancer.
  • The patient must have an ECOG score of 0-2. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, while 2 means the patient is up and about more than half the day.
  • The patient should have a life expectancy of more than 6 months.
  • The patient must provide written informed consent. This means they agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

  • Patients who are not receiving treatment for advanced pancreatic cancer.
  • Patients who are not undergoing chemotherapy with NabG.
  • Patients who are not eligible for VTE prevention. VTE stands for venous thromboembolism, which is a condition where blood clots form in the veins.
  • Patients who are not able to receive the medication tinzaparin. Tinzaparin is a type of medication used to prevent blood clots.
  • Patients who are not in the age range specified for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Bioclinic S.A. Thessaloniki Greece
401 General Military Hospital Of Athens Athens Greece
Aocctr Mssulig Gdtxdp Pghyvtlo Cmoysr Athens Greece
Pzzkihtloiwf Hutnxsll Thessaloniki Greece
Txsloxislt Cqcuna Hrcyfedg Thessaloniki Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Not yet recruiting
11.04.2022

Trial locations

Investigated drugs:

Tinzaparin is a medication used in this study to prevent blood clots in patients with advanced pancreatic cancer. It is administered alongside chemotherapy to help reduce the risk of venous thromboembolism (VTE), which is a common complication in cancer patients. The study aims to see if using tinzaparin can improve the time patients live without their cancer getting worse.

Nab-Paclitaxel (NabG) is a form of chemotherapy used in the treatment of advanced pancreatic cancer. It works by stopping the growth of cancer cells and is used as a first-line treatment in this study. The goal is to evaluate its effectiveness when used together with tinzaparin in preventing cancer progression.

Investigated diseases:

Pancreatic Cancer – Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas, an organ located behind the stomach. It often progresses silently, with symptoms appearing only in advanced stages. As the cancer grows, it can spread to nearby organs and tissues, such as the liver and lymph nodes. The disease can cause symptoms like jaundice, weight loss, and abdominal pain. In advanced stages, it may lead to complications such as blockages in the bile duct or intestines. The progression of pancreatic cancer can vary, but it typically advances quickly once symptoms become noticeable.

Trial ID:
2024-520043-17-00
Protocol code:
imPaCT-PRO-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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