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Spots Global Cancer Trial Database for Personalized Medicine for Advanced Biliary Cancer Patients

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Trial Identification

Brief Title: Personalized Medicine for Advanced Biliary Cancer Patients

Official Title: Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

Study ID: NCT05615818

Study Description

Brief Summary: The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

Detailed Description: This is a Phase 3, multicentre, randomised, open-label trial to evaluate whether the introduction of molecular targeted therapy (MTT) as maintenance after 4 cycles of standard-of-care first-line systemic therapy (1L SoC) is superior to continuation of 1L-SoC in the treatment of patients with ABC. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, and (ii) a randomised comparative trial. The aim of the screening phase is to identify a medically suitable population, to obtain a molecular profile of the patient's tumour, to collect baseline data concerning patient demographics and disease characteristics and to obtain pre-treatment blood and tumour samples for further translational research. A genetic profile will be obtained from tumour-derived DNA and RNA samples by next-generation sequencing and from circulating tumour DNA. The trial Molecular Tumour Board will determine whether each patient harbours a targetable molecular alteration for one or more of the trial MTTs. Patients with disease control after 4 cycles of 1L-SoC, who did not experience limiting toxicity, and whose tumour harbours at least one targetable molecular alteration, will be invited to participate in the randomised phase of the trial in which 159 eligible patients will be randomised (2:1) to receive either maintenance therapy with a matched MTT or to continue 1L-SoC treatment.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cliniques universitaires Saint-Luc, Brussels, , Belgium

CHU Amiens Picardie, Amiens, , France

CHU d'Angers, Angers, , France

Institut du Cancer Avignon Provence, Avignon, , France

CHU de Besançon, Besançon, , France

CHU de Bordeaux - Hôpital Haut-Leveque, Bordeaux, , France

Centre François Baclesse, Caen, , France

Centre Jean Perrin, Clermont-Ferrand, , France

CHU Estaing de Clermont Ferrand, Clermont-Ferrand, , France

APHP - Hopital Henri Mondor, Créteil, , France

CHU de Dijon, Dijon, , France

CHU Grenoble Alpes, Grenoble, , France

Centre Oscar Lambret, Lille, , France

CHU Lille, Lille, , France

CHU Dupuytren, Limoges, , France

Centre Leon Bérard, Lyon, , France

CHU de Lyon, Lyon, , France

Clinique Privée Jean Mermoz, Lyon, , France

APHM - CHU La Timone, Marseille, , France

Institut Paoli Calmettes, Marseille, , France

CHU Montpellier, Montpellier, , France

Institut de Cancer de Montpellier, Montpellier, , France

CHU Nantes - Hôtel Dieu, Nantes, , France

Centre Antoine Lacassagne, Nice, , France

APHP - Hôpital Beaujon, Paris, , France

APHP - Hôpital Cochin, Paris, , France

APHP - Hôpital Saint Antoine, Paris, , France

Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, , France

Institute Mutualiste Montsouris, Paris, , France

Hôpital Privé des Côtes d'Armor, Plérin, , France

CHU Poitiers, Poitiers, , France

CHU de Reims, Reims, , France

Institut Jean Godinot, Reims, , France

Centre Eugène Marquis, Rennes, , France

CHU Charles Nicolle, Rouen, , France

Institut de Cancerologie de l'Ouest, Saint-Herblain, , France

Hôpital Foch, Suresnes, , France

CHU Toulouse, Toulouse, , France

CHRU de Nancy, Vandœuvre-lès-Nancy, , France

APHP - Hôpital Paul Brousse, Villejuif, , France

Gustave Roussy, Villejuif, , France

Queen Elizabeth Hospital, Birmingham, , United Kingdom

Bristol, Bristol, , United Kingdom

Addenbrooke's Hospital, Cambridge, , United Kingdom

Castle Hill Hospital, Cottingham, , United Kingdom

St James's Hospital, Leeds, , United Kingdom

Clatterbridge Centre for Oncology, Liverpool, , United Kingdom

Guy's & St Thomas' Hospital, London, , United Kingdom

Hammersmith Hospital, London, , United Kingdom

Royal Marsden Hospital, London, , United Kingdom

University College London, London, , United Kingdom

Maidstone Hospital, Maidstone, , United Kingdom

The Christie Hospital, Manchester, , United Kingdom

Nottingham University Hospital, Nottingham, , United Kingdom

Oxford, Oxford, , United Kingdom

Sheffield, Sheffield, , United Kingdom

Southampton General Hospital, Southampton, , United Kingdom

Contact Details

Name: Malka David, MD

Affiliation: Institut Mutualiste Montsouris

Role: PRINCIPAL_INVESTIGATOR

Name: Julien Edeline, MD

Affiliation: Centre Eugène Marquis

Role: PRINCIPAL_INVESTIGATOR

Name: Ivan Borbath, MD

Affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Role: PRINCIPAL_INVESTIGATOR

Name: John Bridgewater, MD

Affiliation: University College London Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Name: Juan W Valle

Affiliation: University of Manchester and The Christie NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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