Not recruiting

Study on the Effects of VCN-01 with Nab-Paclitaxel and Gemcitabine for Patients with Advanced Pancreatic Cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying metastatic pancreatic cancer, a type of cancer that has spread from the pancreas to other parts of the body. The study is evaluating a new treatment called VCN-01, which is a genetically modified virus designed to help fight cancer. This treatment is being tested in combination with standard chemotherapy drugs, nab-paclitaxel and gemcitabine. The purpose of the study is to see if adding VCN-01 to the standard treatment can improve the overall survival of patients with advanced pancreatic cancer.

Participants in the study will be randomly assigned to one of two groups. One group will receive the standard chemotherapy treatment, while the other group will receive the standard treatment plus VCN-01. The VCN-01 is given through an intravenous infusion, which means it is delivered directly into the bloodstream. The study will monitor patients over a period of time to assess the safety and tolerability of VCN-01, as well as its impact on survival.

The trial aims to provide valuable information on whether VCN-01 can be a beneficial addition to the current treatment options for metastatic pancreatic cancer. By participating in this study, researchers hope to gather data that could lead to improved treatment strategies for this challenging disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent is required. This involves understanding the study's purpose and agreeing to participate.
Eligibility is confirmed based on specific criteria, including age, diagnosis of metastatic pancreatic cancer, and overall health status.
Step 2
Initial assessment
An initial assessment is conducted to evaluate health status. This includes imaging tests to measure tumor size and laboratory tests to assess organ function.
Step 3
Treatment allocation
Participants are randomly assigned to one of two groups. One group receives standard therapy with nab-paclitaxel and gemcitabine. The other group receives the same standard therapy plus an additional treatment with VCN-01.
Step 4
Treatment administration
Standard therapy involves the administration of nab-paclitaxel and gemcitabine. The frequency and dosage are determined by the healthcare provider.
VCN-01 is administered intravenously at Week 1 and Week 14 for those in the additional treatment group.
Step 5
Ongoing monitoring
Regular monitoring is conducted to assess the treatment's effects. This includes imaging tests and laboratory analyses to track changes in tumor size and overall health.
Safety and tolerability of the treatments are evaluated throughout the study.
Step 6
Completion of study
The study is estimated to conclude by October 2025. Participants' overall survival and health outcomes are assessed at the end of the study.

Who can join the trial?

8 criteria

Provide written informed consent before any study-specific procedures or assessments. This means you agree to participate after understanding the study details.
Be a male or female patient aged 18 years or older.
Have a confirmed diagnosis of metastatic pancreatic adenocarcinoma at stage IV, which is a type of advanced pancreatic cancer. You should not have received any previous treatment for this cancer.
Be willing to follow the study treatment plan.
Have a minimum life expectancy of 5 months.
Have an ECOG performance status of 0 or 1. This is a scale that measures your ability to perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Use a reliable method of contraception if you are a fertile man or woman. Women who can have children must agree to use effective birth control. Men must agree to use effective birth control or be surgically sterile, and all men must use a condom.
Have adequate baseline organ function, which means your blood, liver, kidneys, and nutrition levels are within acceptable ranges based on recent lab tests. This includes specific blood counts, liver enzymes, and kidney function tests.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital General Universitario De Valencia
Verified
Valencia, Spain
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Nab-Paclitaxel
is a type of chemotherapy medication used to treat various cancers, including pancreatic cancer. It works by stopping the growth of cancer cells and is often used in combination with other cancer-fighting drugs to enhance its effectiveness.
Gemcitabine
is another chemotherapy drug that is commonly used to treat pancreatic cancer. It helps to slow or stop the growth of cancer cells and is often used in combination with other medications to improve treatment outcomes.
VCN-01
is an investigational therapy being studied for its potential to treat metastatic pancreatic cancer. It is administered intravenously and is being evaluated for its safety and effectiveness when used alongside other chemotherapy drugs.

Genetically Modified Human Adenovirus Encoding Human Ph20 Hyaluronidase

What is already known about the treatment

Nab-Paclitaxel
This medication is administered intravenously and is used in combination with other drugs for the treatment of metastatic pancreatic cancer. It is currently well-established in medical practice and literature for this indication. Nab-Paclitaxel works by inhibiting cell division, which helps to slow or stop the growth of cancer cells. It belongs to the pharmacological class of taxanes, which are known for their role in cancer treatment.
Gemcitabine
Administered intravenously, Gemcitabine is used alongside other medications to treat metastatic pancreatic cancer. It is a recognized treatment option in medical literature for this condition. The drug works by interfering with DNA synthesis, thereby preventing cancer cells from multiplying. Gemcitabine is classified as an antimetabolite, a type of chemotherapy agent that targets rapidly dividing cells.
VCN-01
This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating metastatic pancreatic cancer. It is not yet widely established in medical practice. VCN-01 is designed to selectively replicate within tumor cells, leading to their destruction. It is classified as an oncolytic virus, a novel approach in cancer therapy that uses viruses to target and kill cancer cells.

Investigated diseases

Metastatic Pancreatic Cancer – This is a type of cancer that begins in the pancreas and spreads to other parts of the body. The pancreas is an organ that helps with digestion and blood sugar regulation. In metastatic pancreatic cancer, cancer cells break away from the original tumor and travel through the blood or lymph system to form new tumors in other organs. This disease often progresses rapidly, as the cancer cells can spread to vital organs such as the liver and lungs. Symptoms may include abdominal pain, weight loss, and jaundice. The progression of the disease can vary, but it typically involves the growth and spread of cancerous cells beyond the pancreas.