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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Unviersitario Miguel Servet	Zaragoza	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hcenebty Uuksonvoqorus Meevcov Dt Vhpqdsusda	Santander	Spain
Ibomzgmk Clhqfi Dxyspfxlmrytdpfdq	L'hospitalet De Llobregat	Spain
Hqxhyioc Voxs dsmvzpuf	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.10.2022

Trial locations

Investigated drugs:

Genetically Modified Human Adenovirus Encoding Human Ph20 Hyaluronidase

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.

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.

Trial ID:

2024-511290-30-00

Protocol code:

P-VCNA-003

NCT ID:

NCT05673811

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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