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NCT05443087Recruiting

TARGETed Therapy Drug MONITOring in DIGestive Oncology

Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
330 (estimated)
First submitted
23 Jun 2022
Start date
29 Aug 2022
Primary completion date
Aug 2026
Lead sponsor
UNICANCER
NCT number
NCT05443087

What you commit to

  • Study type: Interventional
  • Planned participants: 330
  • From 29 Aug 2022 to the primary completion date, Aug 2026
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor hormone therapy or immunotherapy) than the one studied
  • Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and peripheral neuropathy
  • Prior treatment with the same MKI molecule(s) planned to be given in the cohort. If different MKI molecules (from the one(s) planned in the study) have been previously taken, a wash out period of 2 weeks before treatment should be observed.
  • Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product which have a marketed authorisation, used as per the SmPC for the given indication)

Other illness

  • Other invasive malignancies either currently active or active in the last 3 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin
  • Any condition that may jeopardize patient participation in the study as well as non contraception for male and female with child-bearing potential, pregnancy or breast feeding.

Other

  • Patient unwilling or unable to comply with the medical follow-up required by the standard treatment taken (including PK sampling during treatment phase and vital status collection during follow-up phase) because of psychosocial, familial, social or geographical reasons
  • Patient deprived of their liberty or under protective custody or guardianship

Who the study is looking for

  • Patient aged 18 years or over
  • Advanced digestive cancer (histologically confirmed or confirmed by imaging for HCC) for which a standard treatment (according to each drug SmPC and as per standard of care) planned with:
    • Regorafenib for GIST, mCRC, and HCC,
    • Everolimus for gepNET,
    • Sunitinib for pNET or GIST,
    • Cabozantinib for HCC,
    • Encorafenib - cetuximab for mCRC
  • Life expectancy of greater than 3 months - at the discretion of the investigator
  • Measurable disease according to tumor evaluation criteria as per local practice (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)
  • Patients must be affiliated to a Social Security System (or equivalent)
  • Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU d'Amiens Pcardie - Hopital Sud
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
CH d'Auxerre
Coordinator of this site? Confirm its status
AuxerreFranceRecruiting
Institut du Cancer Avignon - Institut Sainte Catherine
Coordinator of this site? Confirm its status
AvignonFranceWithdrawn
CH de Bayeux - Onconormandie
Coordinator of this site? Confirm its status
BayeuxFranceWithdrawn
Centre Jean Perrin
Coordinator of this site? Confirm its status
Clermont-FerrandFranceRecruiting
Hôpital Beaujon - APHP
Coordinator of this site? Confirm its status
ClichyFranceRecruiting
Centre Georges François Leclerc
Coordinator of this site? Confirm its status
DijonFranceWithdrawn
Institut de Cancérologie de Bourgogne
Coordinator of this site? Confirm its status
DijonFranceRecruiting
CH Eure Seine - Hopital d'Evreux Vernon
Coordinator of this site? Confirm its status
ÉvreuxFranceNot yet recruiting
Centre Oscar Lambret
Coordinator of this site? Confirm its status
LilleFranceRecruiting
Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul
Coordinator of this site? Confirm its status
LilleFranceNot yet recruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceWithdrawn
Hopital Europeen Marseille
Coordinator of this site? Confirm its status
MarseilleFranceNot yet recruiting
CHRU de Nancy - Hôpital de Brabois Adulte
Coordinator of this site? Confirm its status
NancyFranceRecruiting
CHU de Nantes - Hôtel Dieu
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Centre Antoine Lacassagne
Coordinator of this site? Confirm its status
NiceFranceWithdrawn
Institut Mutualiste de Montsouris
Coordinator of this site? Confirm its status
ParisFranceRecruiting
APHP Pitié Salpétrière
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hopital Saint Joseph
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hôpital Privé des Côtes d'Armor - SAS
Coordinator of this site? Confirm its status
PlérinFranceRecruiting
CHU de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceNot yet recruiting
Institut Jean Godinot
Coordinator of this site? Confirm its status
ReimsFranceRecruiting
CHU de Reims Hôpital Robert Debré
Coordinator of this site? Confirm its status
ReimsFranceRecruiting
Centre Eugène Marquis
Coordinator of this site? Confirm its status
RennesFranceNot yet recruiting
CHU Rouen Hopital Charles Nicolle
Coordinator of this site? Confirm its status
RouenFranceRecruiting
CH Saint Malo - Hôpital Broussais
Coordinator of this site? Confirm its status
St-MaloFranceRecruiting
ICANS
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
CHU de Tours
Coordinator of this site? Confirm its status
ToursFranceRecruiting
Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.