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Gastroenteropancreatic neuroendocrine tumour disease – Trials in Disease

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Ongoing Clinical Trials for Gastroenteropancreatic Neuroendocrine Tumour Disease

There are currently 14 clinical trials investigating new treatments and diagnostic approaches for gastroenteropancreatic neuroendocrine tumour disease. These studies are taking place across multiple European countries and are testing various treatment options including radioactive therapies, targeted medications, and advanced imaging techniques. Researchers are working to find more effective ways to manage this rare type of cancer that affects the digestive system and pancreas.

Clinical trial locations

Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms

This imaging study is being conducted in Denmark and focuses on improving the prediction of disease progression in patients with neuroendocrine tumors. The trial uses two different radioactive tracers for PET/CT scanning: 64Cu-DOTATATE and 18F-FDG.

Main inclusion criteria: Participants must be between 18 and 65 years old with a confirmed diagnosis of gastro-pancreatic neuroendocrine neoplasm. They must have a WHO Performance status of 0-2, which measures their ability to perform daily activities.

Main exclusion criteria: People under 18 or over 65 years cannot participate. Those unable to undergo PET/CT scanning, pregnant or breastfeeding women, and people with known allergies to the imaging agents are excluded. Participants must not have other active cancers in the past 5 years, severe claustrophobia, or metal implants that could interfere with imaging.

Focus of the trial: The study aims to develop new ways to predict how long patients might remain stable without their disease worsening. This will be done by combining two different types of PET/CT scans. Participants will receive both imaging solutions on the same day through intravenous injections and undergo scanning. The medical team will then monitor their health status until December 2026 to track disease progression.

Investigational agents: 64Cu-DOTATATE is a radioactive tracer that binds to specific receptors commonly found on neuroendocrine tumors, helping doctors visualize where these tumors are located. 18F-FDG (fluorodeoxyglucose) shows areas in the body that use a lot of glucose, which is common in fast-growing cancer cells. Using both tracers together provides complementary information about tumor behavior and activity.

Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas

This Danish study is testing a new combined imaging approach for several cancer types, including neuroendocrine tumors. The research combines Magnetic Resonance Spectroscopy using hyperpolarized [1-13C]pyruvate with PET scanning using 18F-FDG.

Main inclusion criteria: Adults aged 18 to 65 with confirmed diagnosis of breast cancer, neuroendocrine neoplasms, lymphomas, or sarcomas. The tumor must be at least 1.5 centimeters in size.

Main exclusion criteria: People under 18 or over 65 years old cannot participate. Those unable to lie still in the PET/MR scanner for up to 60 minutes, people with claustrophobia, pregnant or breastfeeding women, and patients with severe kidney dysfunction are excluded. People with metal implants incompatible with MRI, known allergies to the imaging substances, or blood glucose levels above 200 mg/dL at imaging time cannot participate.

Focus of the trial: The study aims to determine whether performing both imaging methods simultaneously can better understand how tumors use energy. Participants will receive two injectable substances through intravenous lines and then undergo imaging in a combined PET/MR scanner. This single imaging procedure will help doctors evaluate how tumors process different nutrients.

Investigational agents: Hyperpolarized [1-13C]pyruvate helps doctors see how cancer cells process nutrients differently from normal cells. When injected, it allows visualization of metabolic processes in real-time. 18F-FDG is a radioactive form of glucose that accumulates in cancer cells because they typically consume more glucose than healthy cells, making them visible on PET images.

Study of Intra-Arterial Infusion of Lutetium (177Lu) Oxodotreotide for Adults with Gastroenteropancreatic Neuroendocrine Tumors with Liver Metastases

This French trial is exploring a specialized delivery method for peptide receptor radionuclide therapy in patients whose cancer has spread mainly to the liver. The study involves delivering Lutathera through a method called intra-arterial hepatic infusion, where medication is injected directly into blood vessels supplying the liver.

Main inclusion criteria: Participants must be adults with well-differentiated neuroendocrine tumors of gastrointestinal or pancreatic origin, with liver metastases as the dominant or exclusive site of disease. They must have previously completed four standard cycles of Lutathera and have adequate kidney and liver function, as well as normal blood cell counts. The disease must be measurable by RECIST 1.1 criteria and cannot be surgically removed.

Main exclusion criteria: People who cannot undergo PET scans or receive radiolabeled somatostatin analogs are excluded. The study does not include vulnerable populations who cannot provide informed consent.

Focus of the trial: The trial examines whether delivering Lutathera directly into the liver through intra-arterial infusion is safe and effective. Participants will receive the fifth cycle of therapy via this specialized delivery route. The study monitors both the effectiveness in treating liver metastases and the safety regarding other organs like kidneys, spleen, and bone marrow.

Investigational agents: 68Ga-DOTA-peptides are used for imaging purposes, labeled with radioactive Gallium-68, helping to visualize tumors on PET scans. 177Lu-DOTA-peptides are used for therapy, labeled with radioactive Lutetium-177, designed to deliver radiation directly to tumor cells, helping reduce tumor size and control growth.

Study of Lutetium-177-DOTA-TATE with octreotide LAR in newly diagnosed patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET) with high disease burden

This international trial, taking place in Italy, France, Spain, Poland, Germany, Hungary, and the Netherlands, is testing a combination treatment approach for newly diagnosed patients with advanced disease and high tumor burden.

Main inclusion criteria: Participants must be at least 12 years old (18 or older in some countries) with confirmed advanced or metastatic gastroenteropancreatic neuroendocrine tumor diagnosed within 6 months before screening. The disease must show high burden, which may include tumors larger than 4 cm, multiple tumors over 2 cm, high alkaline phosphatase levels, bone or abdominal lining spread, or symptoms like pain and weight loss. Tumors must show up on somatostatin receptor scans, and participants must have adequate blood counts, kidney and liver function, and at least one measurable tumor.

Main exclusion criteria: People with other cancers within the past 5 years, previous PRRT treatment, severe heart or kidney problems, severe liver problems, pregnancy or breastfeeding, known allergies to study medications, participation in another trial within 30 days, mental conditions interfering with study procedures, severely low blood cell counts, active infections, major surgery within 4 weeks, or life expectancy less than 12 months are excluded.

Focus of the trial: The study compares Lutathera combined with Sandostatin LAR against Sandostatin LAR alone to determine if the combination is more effective at delaying disease progression or extending survival. Participants will be randomly assigned to treatment groups and monitored through regular medical examinations and imaging tests. The study continues until 2035.

Investigational drugs: Lutetium Lu-177 dotatate (Lutathera) is a radioactive medication that delivers targeted radiation to cancer cells having specific receptors on their surface, helping destroy them while minimizing damage to healthy tissue. Octreotide LAR (Sandostatin LAR) is a long-acting medication that helps control symptoms by reducing hormone production and helps slow tumor growth by blocking signals cancer cells use to multiply.

Study on Continuing Somatostatin Analogues with Sunitinib, Octreotide, and Lutetium (177Lu) Oxodotreotide for Patients with Neuroendocrine Tumors

This Belgian and Dutch study examines whether continuing somatostatin analogue treatment when the disease progresses can provide additional benefits when patients start second-line therapy.

Main inclusion criteria: Participants must be at least 18 years old with confirmed locally advanced or metastatic, non-functional, well-differentiated WHO 2019 grade 1-2 gastroenteropancreatic neuroendocrine tumor. They must have documented radiological disease progression while on first-line somatostatin analogue treatment and an ECOG performance status of 2 or less. For the targeted therapy substudy, participants must have an indication to start sunitinib or everolimus; for the PRRT substudy, they must be candidates for PRRT with 177Lu-DOTATATE.

Main exclusion criteria: The study excludes patients with other cancer types, those who haven’t started second-line therapy, patients outside the specified age range, vulnerable populations, and those unwilling or unable to follow study procedures.

Focus of the trial: The study is divided into two parts: one examining effects when patients start PRRT as second-line treatment, and another when they start targeted therapy. The goal is to see if continuing somatostatin analogues can help delay disease worsening and improve quality of life. Participants receive either medication or placebo, and their progress is monitored over time.

Investigational drugs: Somatostatin analogues mimic a natural hormone that helps slow tumor growth by regulating hormone levels and inhibiting substances that promote growth. PRRT (Peptide Receptor Radionuclide Therapy) uses radioactive material attached to a molecule targeting tumor cells, delivering radiation directly to tumors. Targeted therapy includes medications that specifically interfere with cancer’s ability to grow and spread while causing less harm to normal cells.

Study on RYZ101 for Patients with Advanced Gastroenteropancreatic Neuroendocrine Tumors After Previous Treatment

This trial, conducted in France, Netherlands, Spain, and Belgium, is investigating RYZ101 as a new treatment option for patients whose tumors have progressed despite previous therapy with 177Lu-labelled somatostatin analogue.

Main inclusion criteria: Participants must have gastro-enteropancreatic neuroendocrine tumors expressing somatostatin receptors and be candidates for one of several standard treatments (everolimus, sunitinib, high-dose octreotide, or high-dose lanreotide). They must have adequate kidney function with eGFR of 60 or more, adequate blood function with specific hemoglobin, white blood cell, and platelet counts, and total bilirubin three times normal limit or less. Women of childbearing potential must have a negative pregnancy test and agree to use two forms of effective birth control during treatment and for 7 months after. Male participants must use condoms during treatment and for 4 months after.

Main exclusion criteria: Patients without gastro-enteropancreatic neuroendocrine tumors, those whose tumors lack somatostatin receptors, patients not previously treated with 177Lu-SSA, those outside the age range, people unable to follow procedures, pregnant or breastfeeding women, and vulnerable populations are excluded.

Focus of the trial: The study is divided into two parts. The first focuses on finding the right dose of RYZ101 and assessing safety and tolerability. The second aims to see if RYZ101 can help patients live longer without disease progression compared to standard treatments. Participants will be monitored through regular check-ups and assessments.

Investigational drug: RYZ101 is an investigational medication being studied for treating advanced gastro-enteropancreatic neuroendocrine tumors expressing somatostatin receptors that have progressed despite previous treatment with 177Lu-labelled somatostatin analogue. The trial aims to determine appropriate dosage and evaluate safety and effectiveness.

Study on the Safety and Effectiveness of Cabozantinib and Lanreotide for Patients with Gastroenteropancreatic and Thoracic Neuroendocrine Tumors

This Italian study evaluates the combination of cabozantinib and lanreotide for patients with neuroendocrine tumors in the gastroenteropancreatic system and thoracic region, including the lungs.

Main inclusion criteria: Participants must be 18 years or older and provide voluntary written consent. They must have advanced or inoperable neuroendocrine tumors in the pancreas, small intestine, stomach, rectum, lungs, thymus, or unknown primary location. The cancer must be progressive as shown by imaging tests, with at least one measurable tumor. They must have good general health according to ECOG performance status, positive results from imaging or tissue tests showing certain receptors, adequate laboratory test results for blood counts, liver, and kidney function.

Main exclusion criteria: Patients with different cancer types than those being studied, those outside the age range, vulnerable populations, people unable to safely take study medications, those with interfering medical conditions, current participation in another trial, pregnant or breastfeeding women, allergies to study medications, inability to follow procedures, uncontrolled medical conditions, weight over 180 kg, or blood glucose above 200 mg/dL at imaging time are excluded.

Focus of the trial: The study evaluates safety and effectiveness of using cabozantinib and lanreotide together over up to 24 months. Researchers will monitor how well patients tolerate treatment and how tumors respond, while also exploring biological markers that might predict treatment effectiveness or safety. The study is divided into stages, with initial focus on safety and subsequent stages evaluating effectiveness.

Investigational drugs: Cabozantinib works by blocking certain proteins that promote tumor growth and spread. Lanreotide manages symptoms and slows tumor growth by mimicking a natural hormone that helps regulate various body functions. In this trial, both are being combined to evaluate effectiveness and safety in treating neuroendocrine tumors.

Study on the Safety and Effectiveness of Domvanalimab and Zimberelimab for Adults with Advanced Rare Cancers Resistant to Standard Treatment

This French study focuses on testing a combination immunotherapy approach for patients with five rare cancer types, including gastroenteropancreatic neuroendocrine tumors, whose diseases have progressed after standard treatment.

Main inclusion criteria: Participants must have one of five rare cancers (including GEP-NET and carcinoid tumors) that is advanced or metastatic and has shown progression or resistance after at least one standard treatment. They must be at least 18 years old with life expectancy of at least 16 weeks and ECOG performance status of 0 or 1. Participants must be willing to provide tumor tissue samples, have adequate bone marrow, kidney, and liver function, agree to use effective contraception, sign informed consent, be able to comply with the study protocol, and be affiliated with French social security.

Main exclusion criteria: Patients without one of the specified rare cancers, those whose cancer is not advanced or metastatic, those whose cancer is not progressive or resistant after standard treatment, non-adults, and vulnerable populations are excluded.

Focus of the trial: The study evaluates the combination of Domvanalimab and Zimberelimab given through intravenous infusion over 24 weeks. The goal is to determine if this immunotherapy combination provides a new treatment option for these challenging conditions. Participants will be grouped into different cohorts based on their specific cancer type, and researchers will assess outcomes such as cancer progression rate and overall survival.

Investigational drugs: Domvanalimab is an antibody medication that helps the body’s immune system recognize and attack cancer cells by blocking proteins that help cancer cells hide. Zimberelimab is another antibody medication that boosts immune response by targeting and blocking a protein that usually helps cancer cells evade detection. Both are being tested in combination to see if they work better together.

Study of Gallium (68Ga) edotreotide, Fluorocholine (18F) and Fludeoxyglucose (18F) PET imaging for detection and staging of liver cancer and gastro-entero-pancreatic tumors

This French study evaluates a new multiplexed imaging approach that combines multiple PET scans into a single session for detecting and determining the stage of gastro-entero-pancreatic tumors and liver cancer.

Main inclusion criteria: Participants must be 18 years or older, provide written informed consent, be covered by French social security, have good physical performance (ECOG score of 2 or less), have at least one measurable tumor on recent CT or MRI, and be willing to attend all scheduled visits. For patients with gastro-entero-pancreatic tumors, they must have confirmed diagnosis by tissue biopsy and liver or pancreatic involvement. For male participants, condom use is required for 3 months after the scan. Female participants must either have a negative pregnancy test and use effective contraception for 6 months, be post-menopausal, or have had surgical sterilization.

Main exclusion criteria: Pregnant or breastfeeding women, persons under 18, those with severe kidney problems, known allergies to imaging substances, inability to lie still for scanning time, recent nuclear medicine procedures, metal implants interfering with imaging, weight exceeding scanner limits, inability to provide informed consent, current participation in other trials, and certain medical conditions are excluded.

Focus of the trial: The study aims to evaluate whether combining multiple PET scans into a single imaging session provides accurate information about cancer location and extent. Participants will receive injections of two different imaging substances through their veins and undergo scanning. The safety of this combined approach will be monitored, and image quality will be evaluated.

Investigational approach: Multiplexed PET imaging is a novel technique involving simultaneous administration of two different radiopharmaceutical tracers through a single injection route, designed for detecting and staging hepatocellular carcinoma and gastro-entero-pancreatic tumors. This advanced method combines multiple PET scans to provide enhanced diagnostic capabilities.

Study comparing 177Lu-edotreotide versus everolimus in patients with inoperable progressive neuroendocrine tumors of gastroenteric or pancreatic origin

This large international study, taking place in Poland, Czechia, Italy, France, Spain, Austria, Germany, Netherlands, and Belgium, compares radioactive therapy with targeted medication for patients whose tumors cannot be surgically removed and continue to grow.

Main inclusion criteria: Participants must be 18 years or older and provide written informed consent. They must have well-differentiated neuroendocrine tumors of gastroenteric or pancreatic origin that are advanced or metastatic. The disease must be measurable through imaging scans, tumors must be somatostatin receptor positive, and participants must have documented progressive disease on two imaging scans using the same method.

Main exclusion criteria: People with other cancers within the last 3 years, previous PRRT or everolimus treatment, severe heart, kidney, or liver problems, pregnant or breastfeeding women, uncontrolled diabetes, active brain metastases, major surgery within 4 weeks, serious medical conditions interfering with participation, known allergies to study medications, participation in another trial within 30 days, inability to follow procedures or attend visits, or life expectancy less than 6 months are excluded.

Focus of the trial: The study compares 177Lu-Edotreotide given through intravenous infusion with everolimus tablets taken daily to determine which treatment is more effective at slowing tumor growth. Patients receiving radioactive therapy will also get an Arginine-Lysine solution to protect their kidneys. The study continues until March 2029, and participants will be regularly monitored for treatment response and side effects.

Investigational drugs: 177Lu-edotreotide is a radiopharmaceutical administered intravenously as part of PRRT, working by binding to somatostatin receptors on tumor cells while delivering radioactive lutetium-177 to destroy cancer cells. Everolimus is an oral medication belonging to mTOR inhibitors that blocks a specific protein promoting cancer cell growth, thereby helping to slow or stop tumor growth.

Due to the large number of trials (14 in total), only the first 10 have been described in detail above. Additional trials are available for patients to explore through the links provided in the country overview section.

Summary

The ongoing clinical trials for gastroenteropancreatic neuroendocrine tumour disease demonstrate a strong focus on radioactive therapies, particularly those involving lutetium-based treatments. Multiple studies are investigating peptide receptor radionuclide therapy in various forms and delivery methods, reflecting the importance of this treatment approach for this condition.

European countries, especially France, show significant concentration of trial activity, with France hosting nine of the fourteen trials. Other countries with substantial research involvement include Italy, Spain, Germany, and the Netherlands, each hosting multiple studies. This geographic distribution suggests strong European leadership in advancing treatment options for this rare cancer.

The trials cover a broad spectrum of approaches, from advanced imaging techniques to help predict disease progression and guide treatment decisions, to new drug combinations aimed at improving outcomes for patients whose disease has progressed after standard therapy. Several studies specifically address challenging patient populations, including adolescents and those with aggressive forms of the disease.

Many trials compare new treatment approaches against established standard treatments, providing valuable information that will help doctors and patients make informed decisions about care options. The inclusion of quality of life assessments in several studies reflects growing recognition of the importance of maintaining patient well-being throughout treatment.

Ongoing Clinical Trials on Gastroenteropancreatic neuroendocrine tumour disease

  • Study on the Effectiveness and Safety of CAM2029 Compared to Octreotide and Lanreotide in Patients with Gastroenteropancreatic Neuroendocrine Tumors

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy The Netherlands +2

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