Il principale motore di ricerca di sperimentazioni cliniche in Europa

AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES

Questa pagina riassume gli studi clinici che stanno valutando AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES. I trial stanno esaminando soprattutto efficacia e risultati clinici in persone con mesotelioma peritoneale e con cancro del pancreas borderline resecabile. Gli studi sono in fasi diverse e misurano esiti come sopravvivenza libera da progressione e sopravvivenza globale.

Table of contents

Overview of the clinical research

The available data describe two interventional clinical trials that study AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES in cancer care.[1][2] One trial is in people with peritoneal mesothelioma, and the other is in people with ABC borderline resectable pancreatic cancer.[1][2]

Both studies are authorised, but they are at different stages and ask different research questions.[1][2] The main focus is on clinical outcomes such as progression-free survival and overall survival, not on basic laboratory science.[1][2]

Trial in peritoneal mesothelioma

The first study is called IMMUNOPEC and is designed for patients with peritoneal mesothelioma.[1] It is a Phase 2 interventional trial with an enrolment of 18 participants.[1]

This study evaluates a treatment plan that combines neo-adjuvant checkpoint inhibition with nivolumab and dendritic cell therapy, together with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC).[1] Neo-adjuvant means treatment given before the main treatment, usually before surgery.[1]

The brief summary says the goal is to assess the efficacy of (neo-)adjuvant CPI (nivolumab) and DCT (MesoPher) around CRS-HIPEC.[1] The primary outcome is progression-free survival in patients who receive neo-adjuvant and adjuvant treatment with anti-PD-1 and DCT vaccinations, with up to 5 administrations if there is a production shortage.[1]

Trial in borderline resectable pancreatic cancer

The second study is the PREOPANC-6 study, which is for patients with ABC borderline resectable pancreatic cancer.[2] It is listed as a Phase 4 interventional trial with an enrolment of 143 participants.[2]

This study looks at AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES given after FOLFIRINOX chemotherapy.[2] The brief summary says Phase II explores whether adjuvant dendritic cell therapy may improve progression-free survival, while Phase III looks at overall survival.[2]

The primary outcome definition includes progression-free survival measured from the start of study treatment until the first documented recurrent or progressive disease, or death from any cause, whichever happens first.[2] Overall survival is measured from inclusion until death from any cause.[2]

Main endpoints being measured

The most important endpoint in the mesothelioma trial is progression-free survival.[1] This tells researchers how long patients stay without the cancer getting worse after treatment.[1]

In the pancreatic cancer study, the main endpoints are progression-free survival and overall survival.[2] The study also uses the RECIST 1.1 standard to define recurrent or progressive disease, which is a common way to measure how cancer changes on scans.[2]

Who the studies are for

These trials are not open to all cancer patients; they are focused on two specific groups.[1][2] One group has peritoneal mesothelioma, and the other has ABC borderline resectable pancreatic cancer.[1][2]

The source data do not list full inclusion or exclusion criteria, so the exact eligibility rules are not available here.[1][2] From the trial titles and summaries, it is clear that the studies are designed for patients who can receive complex cancer treatment plans that include surgery, chemotherapy, and immunotherapy-based approaches.[1][2]

Study design and phases

Both studies are interventional, which means the research team gives a treatment and then observes the results.[1][2] They are not simple observation studies.[1][2]

The mesothelioma study is in Phase 2, a stage that often looks more closely at whether a treatment may help a selected patient group.[1] The pancreatic cancer study is listed as Phase 4, which is a later stage used to gather additional outcome data in real-world clinical use.[2]

Together, the studies show that AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES is being tested in different treatment settings, with different combinations and different patient groups.[1][2] The main question in both trials is whether these treatment plans improve important cancer outcomes.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-519626-21-00 Phase 2 Peritoneal Mesothelioma Authorised 18
2025-523134-28-00 Phase 4 ABC borderline resectable pancreatic cancer Authorised 143

FAQ

  • What conditions are being studied in these trials? The trials are studying peritoneal mesothelioma and borderline resectable pancreatic cancer. These are the only conditions listed in the source data.
  • Who can take part in these studies? One study includes patients with peritoneal mesothelioma, and the other includes patients with ABC borderline resectable pancreatic cancer. Exact entry rules are not provided in the source data.
  • What phases are these trials in? One study is Phase 2 and the other is Phase 4. This means the research is at different stages of testing and follow-up.
  • What are the trials trying to measure? The main outcomes are progression-free survival and overall survival. Progression-free survival means how long patients live without the cancer getting worse, while overall survival means how long patients live after joining the study.
  • Are these studies only using AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES by itself? No. One trial studies it together with nivolumab, surgery, and hyperthermic intraperitoneal chemotherapy, while the other studies it after FOLFIRINOX chemotherapy. The trials are looking at these treatment plans, not the substance alone.

Sperimentazioni cliniche in corso su AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES

  • Studio randomizzato su pazienti con cancro pancreatico borderline resecabile: terapia con cellule dendritiche autologhe caricate con lisato di linee di mesotelioma

    Arruolamento non iniziato

    1 1 1
    Farmaci in studio:
    Paesi Bassi

  • Studio sull’efficacia di Nivolumab e MesoPher in combinazione per pazienti con Mesotelioma Peritoneale

    Arruolamento non iniziato

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Paesi Bassi

Glossario

  • Clinical trial: A research study in people that tests a treatment or treatment plan to see how well it works and how safe it is.
  • Interventional study: A study where researchers give a treatment or treatment combination to participants and then measure the results.
  • Phase 2: An earlier stage trial that usually looks more closely at whether a treatment may work in a specific group of patients.
  • Phase 4: A later stage trial done after a treatment is already in wider use, often to collect more information about outcomes.
  • Peritoneal mesothelioma: A cancer that starts in the lining of the abdomen, called the peritoneum.
  • Borderline resectable: A term used when a tumor may be difficult to remove with surgery, but surgery may still be possible in some cases.
  • Progression-free survival: The length of time during which the cancer does not get worse.
  • Overall survival: The length of time from the start of a study until death from any cause.
  • RECIST 1.1: A standard way to measure whether a cancer is shrinking, staying stable, or growing.
  • Cytoreductive surgery: An operation that tries to remove as much visible cancer as possible.
  • Hyperthermic intraperitoneal chemotherapy: A treatment that gives heated chemotherapy inside the abdomen during surgery.