Ongoing Clinical Trials for Gastrointestinal Neuroendocrine Tumour
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for gastrointestinal neuroendocrine tumours. This trial is testing a combination of two radioactive therapies designed to target tumours that cannot be removed by surgery. The study is being conducted in Poland and aims to develop personalized treatment options for patients with this rare type of tumour.
Clinical trial locations
Study of Lutetium-177 and Yttrium-90 DOTATATE combination therapy for patients with inoperable gastrointestinal neuroendocrine tumors
This clinical trial focuses on treating patients with neuroendocrine tumours of the gastrointestinal tract using a combination therapy called DuoNEN. The treatment consists of two radioactive substances: Lutetium-177 and Yttrium-90, which are combined with a special molecule called DOTATATE. These substances are designed to target and treat tumours that cannot be removed by surgery.
Main inclusion criteria:
- You must have a confirmed diagnosis of a neuroendocrine tumour in the digestive system that cannot be surgically removed
- Your tumour must show high levels of specific receptors on special imaging tests performed within the last 12 weeks
- Recent CT or MRI scans must show that your tumour has grown in size within the last 18 months
- Your blood test results must meet certain minimum levels, including hemoglobin above 9g/dl, blood platelets above 100,000/μl, and white blood cells above 3,000/μl
- Your kidney function must be adequate, with creatinine less than 120 μmol/l or a kidney filtration rate above 45 ml/min
- Your liver function tests should not exceed 3 times the normal range
- You must have a Karnofsky score of 60% or higher, which measures your ability to perform daily activities
- You must be 18 years old or older with a life expectancy of more than 6 months
Main exclusion criteria:
- You cannot participate if you are under 18 years old, pregnant, or breastfeeding
- Previous treatment with peptide receptor radionuclide therapy is not allowed
- Severe kidney dysfunction with creatinine clearance less than 40 mL/min excludes participation
- Severe liver dysfunction or bone marrow dysfunction are not permitted
- You cannot participate if your life expectancy is less than 3 months
- Active participation in other clinical trials is not allowed
- Mental conditions that prevent understanding of the study procedures exclude participation
- Known allergies to the study medications or their components are not permitted
Focus and goal of the trial:
The purpose of this study is to develop a personalized treatment approach for patients with gastroenteropancreatic neuroendocrine tumours using a mixture of radioactive medications. The treatment will be administered through injection, and patients will receive carefully calculated doses of the medication based on their individual needs.
During the study, you will undergo regular medical examinations and monitoring. The treatment effectiveness will be evaluated through various imaging tests, including CT or MRI scans, at specific intervals: 3, 6, 12, 24, 36, 48, and 60 months after completing therapy. Regular blood tests will also be performed every 3 months during the observation period to ensure your safety throughout the treatment. The study will continue monitoring your condition until September 2027.
Investigational drugs:
The study uses two investigational drugs in combination:
LutaPol (Lutetium-177 DOTATATE) is a radioactive medication that works by attaching to specific receptors on tumour cells and delivering targeted radiation to destroy cancer cells. This treatment allows for precise delivery of radiation directly to the tumour while minimizing damage to healthy tissue.
ItraPol (Yttrium-90 DOTATATE) is also a radioactive treatment that targets specific receptors on tumour cells, but it uses a different type of radiation to kill cancer cells. When used together with Lutetium-177 DOTATATE as a combination therapy, this approach allows for more personalized and potentially more effective treatment based on each patient’s specific condition.
Summary
Currently, there is one active clinical trial investigating new treatment options for gastrointestinal neuroendocrine tumours. This study is being conducted in Poland and focuses on patients whose tumours cannot be removed by surgery. The trial tests a novel combination approach using two different radioactive therapies that target specific receptors on tumour cells, offering a personalized treatment strategy for this rare type of cancer. The study includes comprehensive monitoring over a five-year period to assess both the safety and effectiveness of this combination therapy. Patients interested in participating should discuss their eligibility with their healthcare provider, particularly regarding the specific blood test, kidney function, and liver function requirements.
