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Study of AdVince (Modified Adenovirus) Treatment Through Hepatic Artery Injection in Patients with Advanced Neuroendocrine Neoplasms

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What is this study about?

This study focuses on treating neuroendocrine neoplasms (NENs), a group of tumors that can develop in various organs, most commonly in the digestive system and lungs. These tumors are often discovered at an advanced stage when they have already spread to other parts of the body. While surgery can cure some cases, more than half of patients have cancer that has spread, making complete removal impossible.

The treatment being tested is called AdVince (also known as ELC-100), which is a modified virus solution that is injected directly into the liver’s artery. This medication is a specially engineered version of a human virus that has been modified to target tumor cells. The main purpose of this research is to determine if repeated injections of AdVince into the liver artery are safe for patients with NENs that have spread to other parts of the body.

The study involves giving participants injections of AdVince through the liver artery. During the treatment, doctors will monitor patients’ health through blood tests and various imaging techniques including CT scans, MRI, and PET scans. They will also track how the body responds to the treatment by measuring substances in the blood that can indicate tumor activity. The treatment period lasts up to 7 days, and patients will be monitored for any side effects.

1 Initial assessment

Your eligibility for the study will be evaluated based on medical history and test results.

Various tests will be performed, including blood tests to check liver function, blood cell counts, and clotting factors.

Imaging tests will confirm that less than 60% of your liver is affected by the disease.

2 Treatment preparation

Your liver blood flow will be evaluated to ensure proper treatment delivery.

If you have a functioning neuroendocrine tumor, you will receive somatostatin analog medication.

3 Treatment administration

You will receive AdVince, a solution for injection, directly into the liver artery.

The treatment consists of multiple infusions over several cycles.

Blood samples will be collected before injection, 24 hours after, and optionally 72 hours after injection.

4 Monitoring during treatment

Your blood will be tested on days 1, 8, 22, and 50 to measure virus levels.

Your immune response will be checked through blood tests at the start, on day 8, and day 50.

Regular assessments will monitor any side effects of the treatment.

5 Imaging and evaluation

You will undergo imaging tests (CT, PET, and/or MRI) before the first treatment and after the last treatment cycle.

Hormone levels will be regularly monitored throughout the treatment period.

Your disease progression will be evaluated 24 weeks after the fourth treatment cycle.

6 Follow-up period

You will be monitored for 30 days after the last treatment dose.

Any side effects or changes in your condition will be documented during this period.

Who Can Join the Study?

  • Must provide written consent to participate in the study
  • Must be 18 years or older
  • Must use reliable contraception if sexually active and able to have children
  • Must have normal kidney function (creatinine blood test below 105 µg/ml)
  • Must have liver function tests (AST, ALT) less than 5 times the normal limit
  • Must have bilirubin (liver function test) less than 3 times the normal limit
  • Must have normal blood clotting tests (PT/INR below 2.0 and normal PTT)
  • Must have adequate blood cell counts:
    – White blood cells (neutrophils) above 1,500/µl
    – Red blood cells (hemoglobin) above 100 g/L
    – Platelets above 100,000/µl
  • If you have an active hormone-producing tumor, you must be taking somatostatin medications
  • Must have confirmed neuroendocrine tumor from gut, pancreas, or lung origin
  • Must show disease progression in the last 6 months on CT or MRI scans
  • Must have disease that cannot be removed by surgery
  • Must have tried all standard treatment options according to European guidelines
  • Must have proper blood flow to the liver
  • Must have cancer mainly affecting the liver, with less than 60% of liver involved
  • Must have good physical function (Karnofsky score 70% or higher, meaning able to care for self but unable to work)
  • Must have life expectancy of at least 6 months

Who Cannot Join the Study?

  • Prior treatment with any oncolytic virus therapy or gene therapy
  • Active autoimmune disease (a condition where your immune system attacks healthy cells in your body)
  • Presence of brain metastases (cancer that has spread to the brain)
  • Severe liver dysfunction
  • Active or chronic viral infections including hepatitis B, hepatitis C, or HIV
  • Pregnant or breastfeeding women
  • History of organ transplantation
  • Current use of systemic immunosuppressive medications (drugs that weaken the immune system)
  • Significant heart disease or uncontrolled high blood pressure
  • Other active cancers within the past 3 years (except for adequately treated non-melanoma skin cancer)
  • Major surgery within 4 weeks before starting the study
  • Known allergy or hypersensitivity to study medication components
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Uizxgue Ugaosectsg Hlbdkzvk Uppsala Sweden

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

Trial status

Country Status Recruitment Start
Sweden Sweden
Not recruiting
01.03.2016

Trial locations

Investigated drugs:

AdVince is a medical treatment that uses a modified virus (recombinant adenovirus) designed to target neuroendocrine tumors. It is given through infusion into the liver artery to reach cancer cells that have spread to the liver. This type of treatment is known as gene therapy, where the modified virus is engineered to specifically attack cancer cells while leaving healthy cells unharmed. The treatment is administered multiple times through the hepatic artery (the blood vessel that supplies blood to the liver).

Investigated diseases:

Neuroendocrine neoplasms (NENs) – A diverse group of tumors that develop from specialized cells called neuroendocrine cells. These tumors can occur throughout the body but are most commonly found in the digestive system (gastroenteropancreatic system) and lungs. The condition varies in how it presents and develops, with different tumors showing different growth patterns and behaviors. Neuroendocrine neoplasms can produce various hormones and chemicals that affect body functions. The disease typically develops slowly over time, though some forms may grow more rapidly. These tumors can spread from their original location to other parts of the body, particularly to the liver.

Trial ID:
2024-517654-10-00
Protocol code:
VIRUSNET201401
NCT ID:
NCT02749331
Trial Phase:
Human Pharmacology (Phase I) – First administration to humans

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