Actively Recruiting
Personalized Medicine for Advanced Biliary Cancer Patients
Led by UNICANCER · Updated on 2025-04-23
800
Participants Needed
69
Research Sites
202 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
C
Cancer Research UK & UCL Cancer Trials Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Medicine for Advanced Biliary Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Histologically confirmed intrahepatic, perihilar, distal cholangiocarcinoma, or gallbladder carcinoma (excluding ampullary carcinoma)
- De novo or recurrent locally advanced (unresectable) or metastatic disease
- Availability of suitable tumor tissue sample or ability to undergo biopsy
- Age 18 years or older
- ECOG performance status of 0 or 1
- Estimated life expectancy greater than 3 months
- Candidate for or started first-line standard-of-care therapy
- Affiliated with social security or equivalent health insurance
- Molecular profile showing targetable tumor alteration for randomized phase
- Disease controlled after 4 cycles of first-line therapy
- Adequate bone marrow, liver, kidney, cardiac function and biliary drainage
- Men and women of childbearing potential agree to use contraception
- Negative pregnancy test for women of childbearing potential
- Willing and able to comply with study protocol and visits
You will not qualify if you...
- Contraindication to first-line standard-of-care therapy
- Candidates for locoregional therapy
- Contraindication to tumor biopsy if no archived tissue available
- Prior palliative anticancer therapy except adjuvant capecitabine completed over 183 days ago
- More than 1 cycle of first-line therapy received
- Prior treatment with molecular targeted therapies under study
- Other current malignancies except treated in situ cervical carcinoma or certain skin cancers
- Conditions that make participation undesirable or jeopardize compliance
- Pregnant or breastfeeding women
- Unable or unwilling to comply with follow-up due to social or psychological reasons
- Individuals deprived of liberty or under guardianship
- Disease progression or unresolved toxicities before randomization
- Hypersensitivity or contraindications to targeted therapies
- Microsatellite instability high or mismatch repair deficient cancers
- Recent major surgery or radiotherapy
- Untreated or symptomatic brain metastases
- Significant cardiovascular or respiratory diseases
- Hearing loss or tinnitus from cisplatin therapy
- Known leptomeningeal disease
- Use of certain medications or infections such as active hepatitis or HIV
- Participation in another therapeutic trial within 30 days
- Specific exclusions for targeted therapies including swallowing difficulties, malabsorption, certain cardiac, eye, or metabolic conditions, and drug interactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 69 locations
1
Cliniques universitaires de Bruxelles - Hôpital Erasme ULB
Brussels, Belgium
Not Yet Recruiting
2
Cliniques universitaires Saint-Luc
Brussels, Belgium
Not Yet Recruiting
3
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
Not Yet Recruiting
4
Universitair Ziekenhuis Leuven
Leuven, Belgium
Not Yet Recruiting
5
CHU Amiens Picardie
Amiens, France
Actively Recruiting
6
CHU d'Angers
Angers, France
Actively Recruiting
7
Institut de cancerologie de l'Ouest - Angers
Angers, France
Actively Recruiting
8
Institut du Cancer Avignon Provence
Avignon, France
Actively Recruiting
9
CHU de Besançon
Besançon, France
Actively Recruiting
10
CHU de Bordeaux - Hôpital Haut-Leveque
Bordeaux, France
Not Yet Recruiting
11
Centre François Baclesse
Caen, France
Actively Recruiting
12
Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
13
CHU Estaing de Clermont Ferrand
Clermont-Ferrand, France
Actively Recruiting
14
APHP - Hopital Henri Mondor
Créteil, France
Actively Recruiting
15
CHU de Dijon
Dijon, France
Actively Recruiting
16
CHU Grenoble Alpes
Grenoble, France
Not Yet Recruiting
17
Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard
Grenoble, France
Actively Recruiting
18
Centre Oscar Lambret
Lille, France
Actively Recruiting
19
CHU Lille
Lille, France
Actively Recruiting
20
CHU Dupuytren
Limoges, France
Actively Recruiting
21
Centre Leon Bérard
Lyon, France
Not Yet Recruiting
22
Clinique Privée Jean Mermoz
Lyon, France
Not Yet Recruiting
23
Hospices Civils de Lyon - Croix Rousse
Lyon, France
Actively Recruiting
24
APHM - CHU La Timone
Marseille, France
Not Yet Recruiting
25
Hôpital Européen
Marseille, France
Actively Recruiting
26
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
27
Institut de Cancer de Montpellier
Montpellier, France
Actively Recruiting
28
CHU Nantes - Hôtel Dieu
Nantes, France
Not Yet Recruiting
29
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
30
APHP - Hôpital Beaujon
Paris, France
Actively Recruiting
31
APHP - Hôpital Cochin
Paris, France
Actively Recruiting
32
APHP - Hôpital Saint Antoine
Paris, France
Actively Recruiting
33
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France
Not Yet Recruiting
34
Institute Mutualiste Montsouris
Paris, France
Actively Recruiting
35
CH de Pau
Pau, France
Actively Recruiting
36
CHU Poitiers
Poitiers, France
Actively Recruiting
37
CH Cornouaille
Quimper, France
Actively Recruiting
38
CHU de Reims
Reims, France
Actively Recruiting
39
Institut Jean Godinot
Reims, France
Actively Recruiting
40
Centre Eugène Marquis
Rennes, France
Actively Recruiting
41
CHU Charles Nicolle
Rouen, France
Not Yet Recruiting
42
Institut Curie - Saint Cloud
Saint-Cloud, France
Not Yet Recruiting
43
Institut de Cancerologie de l'Ouest
Saint-Herblain, France
Not Yet Recruiting
44
Hôpital Foch
Suresnes, France
Actively Recruiting
45
CHU Toulouse
Toulouse, France
Actively Recruiting
46
CH Valence
Valence, France
Actively Recruiting
47
CHRU de Nancy
Vandœuvre-lès-Nancy, France
Actively Recruiting
48
APHP - Hôpital Paul Brousse
Villejuif, France
Not Yet Recruiting
49
Gustave Roussy
Villejuif, France
Actively Recruiting
50
Queen Elizabeth Hospital
Birmingham, United Kingdom
Actively Recruiting
51
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Actively Recruiting
52
Addenbrooke's Hospital
Cambridge, United Kingdom
Not Yet Recruiting
53
Castle Hill Hospital
Cottingham, United Kingdom
Not Yet Recruiting
54
St James's Hospital
Leeds, United Kingdom
Not Yet Recruiting
55
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Not Yet Recruiting
56
Guy's & St Thomas' Hospital
London, United Kingdom
Not Yet Recruiting
57
Hammersmith Hospital
London, United Kingdom
Actively Recruiting
58
Royal Free Hospital
London, United Kingdom
Not Yet Recruiting
59
Royal Marsden Hospital
London, United Kingdom
Actively Recruiting
60
University College London
London, United Kingdom
Actively Recruiting
61
Maidstone Hospital
Maidstone, United Kingdom
Not Yet Recruiting
62
The Christie Hospital
Manchester, United Kingdom
Not Yet Recruiting
63
Mount Vernon Cancer Centre
Northwood, United Kingdom
Actively Recruiting
64
Nottingham University Hospital
Nottingham, United Kingdom
Actively Recruiting
65
Churchill Hospital
Oxford, United Kingdom
Not Yet Recruiting
66
North West Anglia NHS Foundation Trust
Peterborough, United Kingdom
Not Yet Recruiting
67
Weston Park Cancer Centre
Sheffield, United Kingdom
Not Yet Recruiting
68
Southampton General Hospital
Southampton, United Kingdom
Not Yet Recruiting
69
Singleton Hospital
Swansea, United Kingdom
Not Yet Recruiting
Research Team
M
Marta Jimenez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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