Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05443087

TARGETed Therapy Drug MONITOring in DIGestive Oncology

Led by UNICANCER · Updated on 2025-03-30

330

Participants Needed

29

Research Sites

248 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.

CONDITIONS

Official Title

TARGETed Therapy Drug MONITOring in DIGestive Oncology

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 years or over
  • Advanced digestive cancer confirmed by histology or imaging for HCC
  • Planned standard treatment with regorafenib for GIST, mCRC, or HCC
  • Planned standard treatment with everolimus for gastroenteropancreatic neuroendocrine tumor
  • Planned standard treatment with sunitinib for pancreatic neuroendocrine tumor or GIST
  • Planned standard treatment with cabozantinib for HCC
  • Planned standard treatment with encorafenib-cetuximab for metastatic colorectal cancer
  • Life expectancy greater than 3 months as judged by the investigator
  • Measurable disease by tumor evaluation criteria per local practice
  • Affiliated to a Social Security System or equivalent
  • Signed informed consent form prior to trial procedures
Not Eligible

You will not qualify if you...

  • Receiving other anticancer systemic treatments besides the study drugs
  • Unresolved toxicity higher than Grade 1 from prior therapies except alopecia and peripheral neuropathy
  • Prior treatment with the same multikinase inhibitor planned in the study
  • Other invasive malignancies active or within last 3 years except certain treated skin or cervical cancers
  • Conditions that may risk study participation including lack of contraception for those with child-bearing potential, pregnancy, or breastfeeding
  • Unable or unwilling to comply with required medical follow-up and pharmacokinetic sampling
  • Participation in another clinical trial with an investigational drug within 30 days prior to inclusion
  • Patient deprived of liberty or under protective custody or guardianship

AI-Screening

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Trial Site Locations

Total: 29 locations

1

CHU d'Amiens Pcardie - Hopital Sud

Amiens, France

Actively Recruiting

2

CH d'Auxerre

Auxerre, France

Actively Recruiting

3

Institut du Cancer Avignon - Institut Sainte Catherine

Avignon, France

Withdrawn

4

CH de Bayeux - Onconormandie

Bayeux, France

Withdrawn

5

Centre Jean Perrin

Clermont-Ferrand, France

Actively Recruiting

6

Hôpital Beaujon APHP

Clichy, France

Actively Recruiting

7

Centre Georges Francois Leclerc

Dijon, France

Withdrawn

8

Institut de Cancérologie de Bourgogne

Dijon, France

Actively Recruiting

9

CH Eure Seine - Hopital d'Evreux Vernon

Évreux, France

Not Yet Recruiting

10

Centre Oscar Lambret

Lille, France

Actively Recruiting

11

Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul

Lille, France

Not Yet Recruiting

12

Centre Léon Bérard

Lyon, France

Withdrawn

13

Hôpital Européen Marseille

Marseille, France

Not Yet Recruiting

14

CHRU de Nancy - Hôpital de Brabois Adulte

Nancy, France

Actively Recruiting

15

CHU de Nantes - Hôtel Dieu

Nantes, France

Actively Recruiting

16

Centre Antoine Lacassagne

Nice, France

Withdrawn

17

APHP Pitié Salpétrière

Paris, France

Actively Recruiting

18

Hôpital Saint Joseph

Paris, France

Actively Recruiting

19

Institut Mutualiste de Montsouris

Paris, France

Actively Recruiting

20

Hôpital Privé des Côtes d'Armor - SAS

Plérin, France

Actively Recruiting

21

CHU de Poitiers

Poitiers, France

Not Yet Recruiting

22

CHU de Reims - Hôpital Robert Debré

Reims, France

Actively Recruiting

23

Institut Jean Godinot

Reims, France

Actively Recruiting

24

Centre Eugène Marquis

Rennes, France

Not Yet Recruiting

25

CHU Rouen - Hôpital Charles Nicolle

Rouen, France

Actively Recruiting

26

CH Saint Malo - Hôpital Broussais

St-Malo, France

Actively Recruiting

27

ICANS

Strasbourg, France

Actively Recruiting

28

CHU de Tours

Tours, France

Actively Recruiting

29

Gustave Roussy

Villejuif, France

Actively Recruiting

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Research Team

M

Michaël CHEVROT, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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TARGETed Therapy Drug MONITOring in DIGestive Oncology | DecenTrialz