Ongoing Clinical Trials for Neuroendocrine Carcinoma Metastatic
There are currently 5 clinical trials underway for patients with neuroendocrine carcinoma metastatic, exploring new imaging techniques, chemotherapy combinations, and targeted therapies. These studies are being conducted in Denmark, France, Sweden, and Italy, offering opportunities for patients to access investigational treatments aimed at improving disease management and survival outcomes.
Clinical trial locations
- Denmark
- 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
- Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms
- France
- Italy
- Sweden
Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms
This trial is investigating advanced imaging methods to predict how long patients with neuroendocrine neoplasms might remain stable before their disease progresses. The study uses two different imaging tracers—64Cu-DOTATATE and 18F-FDG—administered through intravenous injections, followed by PET/CT scanning. The combination of these two imaging agents provides detailed information about tumor characteristics and metabolic activity.
Inclusion criteria: Participants must be between 18 and 65 years old with a confirmed diagnosis of gastro-pancreatic neuroendocrine neoplasm or metastases suggesting this type of cancer. They should have a WHO Performance status of 0-2, meaning they can care for themselves with minimal limitations. Both men and women can participate.
Exclusion criteria: The trial excludes patients under 18 or over 65 years old, those unable to undergo PET/CT scanning, individuals with known allergies to the imaging agents, pregnant or breastfeeding women, and those with severe claustrophobia or metal implants that could interfere with imaging. People who participated in another clinical trial within the past 30 days or have a history of other active cancers in the past 5 years are also excluded.
Focus: The study aims to develop new predictive models for disease progression by analyzing measurements from combined scans. Participants undergo two imaging sessions on the same day, followed by monitoring until December 2026 to track disease progression and overall survival.
Investigational agents: 64Cu-DOTATATE binds to receptors commonly found on neuroendocrine tumors, helping visualize their location. 18F-FDG shows areas of high glucose consumption, indicating tumor activity. Together, these tracers provide complementary information about tumor behavior.
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 imaging study tests a new approach combining Magnetic Resonance Spectroscopy using hyperpolarized [1-13C]pyruvate with PET scanning using 18F-FDG. The research aims to better understand how tumors use energy and may lead to improved methods for detecting and monitoring various cancers, including neuroendocrine neoplasms.
Inclusion criteria: Adults aged 18 to 65 years with a confirmed diagnosis of breast cancer, neuroendocrine neoplasm, lymphoma, or sarcoma are eligible. The tumor must measure at least 1.5 centimeters. Both men and women can participate.
Exclusion criteria: The study excludes individuals under 18 or over 65, those unable to lie still for up to 60 minutes, people with claustrophobia or non-MRI-compatible metal implants, pregnant or breastfeeding women, patients with severe kidney dysfunction or known allergies to imaging substances, and those who received experimental drugs within 30 days. Patients weighing more than 180 kg or with blood glucose levels above 200 mg/dL at imaging time are also excluded.
Focus: The trial examines whether both imaging methods can be performed simultaneously to provide detailed information about tumor metabolism. Participants receive two injectable substances through intravenous infusions, followed by imaging in a combined PET/MR scanner.
Investigational agents: Hyperpolarized [1-13C]pyruvate helps visualize how cancer cells process nutrients in real-time, while 18F-FDG accumulates in cells with high glucose consumption, typically seen in cancer. The combination provides complementary metabolic information using two different imaging techniques.
Study Comparing FOLFIRINOX and Cisplatin-Etoposide for Patients with Metastatic Gastroenteropancreatic Neuroendocrine Carcinoma
This trial compares two chemotherapy regimens for metastatic grade 3 poorly differentiated neuroendocrine carcinoma affecting the digestive system. The study aims to determine which treatment—mFOLFIRINOX or platinum-etoposide combination—is more effective in helping patients live longer without disease progression.
Inclusion criteria: Participants must be at least 18 years old with grade 3 neuroendocrine carcinoma or similar high-grade cancer originating from the gastro-entero-pancreatic area or of unknown origin. The cancer must have spread to other parts of the body, and this must be the first treatment for metastatic disease. Patients need an ECOG performance status of 0 or 1, at least one measurable tumor on imaging, and adequate blood test results showing normal liver and kidney function.
Exclusion criteria: The trial excludes patients with other cancer types not being studied, those who received cancer treatment recently, individuals with serious health conditions that could interfere with the study, pregnant or breastfeeding women, and those unable to follow study procedures. People with allergies to study medications, recent participation in another trial, drug or alcohol abuse history, certain infections, or inability to give informed consent are also excluded.
Focus: The research monitors progression-free survival and overall response to treatment through regular assessments using CT scans or MRI. The study also collects genetic information about the cancer to identify potential targets for future therapies and continues until 2029.
Investigational drugs: FOLFIRINOX is a combination of four chemotherapy drugs that attack cancer cells in multiple ways. Platinum drugs damage cancer cell DNA to prevent growth and division. Etoposide interferes with cancer cell DNA, preventing division and growth. All medications are administered intravenously.
Study of AdVince (Modified Adenovirus) Treatment Through Hepatic Artery Injection in Patients with Advanced Neuroendocrine Neoplasms
This study tests AdVince, a specially engineered virus solution injected directly into the liver’s artery to target neuroendocrine neoplasms that have spread to the liver. The main purpose is to determine if repeated injections are safe for patients with advanced disease.
Inclusion criteria: Patients must be 18 years or older with written consent to participate and use reliable contraception if sexually active. They need normal kidney function, liver function tests less than 5 times the normal limit, adequate blood cell counts, and if they have an active hormone-producing tumor, must be taking somatostatin medications. The disease must be confirmed neuroendocrine tumor from gut, pancreas, or lung origin, showing progression in the last 6 months, not removable by surgery, with all standard treatments tried. Cancer must mainly affect the liver with less than 60% involvement, proper liver blood flow, good physical function, and at least 6 months life expectancy.
Exclusion criteria: The trial excludes patients with prior oncolytic virus or gene therapy, active autoimmune disease, brain metastases, severe liver dysfunction, active viral infections including hepatitis B/C or HIV, pregnant or breastfeeding women, history of organ transplantation, current use of immunosuppressive medications, significant heart disease or uncontrolled high blood pressure, other active cancers within 3 years, major surgery within 4 weeks, and known allergies to study medication components.
Focus: The treatment involves multiple infusions of AdVince into the liver artery over several cycles, with blood samples collected to measure virus levels and immune response. Regular imaging tests monitor disease progression, and patients are followed for 30 days after the last treatment dose.
Investigational drug: AdVince is a recombinant adenovirus-based gene therapy that uses a modified virus engineered to specifically attack cancer cells in the liver while leaving healthy cells unharmed. It is administered through hepatic artery infusion.
Study of Durvalumab, Carboplatin and Etoposide combination therapy for patients with metastatic large-cell neuroendocrine lung cancer who have not received previous treatment
This trial tests a combination of three medications—durvalumab, carboplatin, and etoposide—for patients with metastatic pulmonary large-cell neuroendocrine carcinoma who have not received previous treatment. The study aims to determine how effective this combination is in treating this rare and aggressive type of lung cancer.
Inclusion criteria: Participants must be at least 18 years old, weigh more than 30 kg, and have confirmed pulmonary large-cell neuroendocrine carcinoma through tissue testing. They must have advanced disease (Stage IV or inoperable Stage IIIB), at least one measurable tumor visible on scans, adequate blood cell counts, normal liver and kidney function, and good physical function (ECOG 0-1). Women who can become pregnant must have a negative pregnancy test and use effective birth control during treatment and for 6 months after, as must men.
Exclusion criteria: The trial excludes patients with previous treatment for metastatic disease, active or untreated brain metastases, other cancers within the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ), severe heart conditions, active infections including hepatitis B/C or HIV, autoimmune conditions requiring treatment, severe lung disease, pregnant or breastfeeding women, those unable to give informed consent, allergic reactions to study medications, recent participation in another trial, psychiatric conditions, substance abuse, or serious infections requiring antibiotics within 14 days.
Focus: Patients receive four cycles of all three medications through intravenous infusion, followed by durvalumab alone as maintenance therapy. Regular assessments track tumor response using CT scans or MRI, monitor side effects through blood tests checking blood count, liver, and kidney function, and continue follow-up until June 2026.
Investigational drugs: Durvalumab is an immunotherapy that helps the immune system fight cancer by blocking a protein cancer cells use to hide. Carboplatin is a platinum-based chemotherapy that interferes with cancer cell DNA. Etoposide blocks an enzyme cancer cells need to divide and grow. These medications work together, with chemotherapy attacking cancer cells directly while immunotherapy enhances the body’s natural defenses.
Summary
The five ongoing trials for neuroendocrine carcinoma metastatic reflect diverse approaches to understanding and treating this disease. Two Danish studies focus on advanced imaging techniques to better predict disease progression and understand tumor metabolism, offering non-invasive methods to evaluate patient outcomes. The remaining three trials test active treatments: a French study comparing two chemotherapy combinations for gastroenteropancreatic disease, a Swedish trial investigating gene therapy delivered directly to the liver, and an Italian study combining immunotherapy with chemotherapy for lung-based disease.
Geographically, the trials are distributed across four European countries, with Denmark leading in imaging research. The treatment approaches vary significantly—from traditional chemotherapy combinations to innovative gene therapy and immunotherapy—reflecting the complexity of this disease and the need for multiple therapeutic strategies. Notably, several trials target liver metastases, acknowledging the liver as a common site of spread in neuroendocrine carcinomas.
Patients interested in participating should discuss eligibility with their healthcare providers, as each trial has specific requirements regarding disease characteristics, previous treatments, and overall health status.
