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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d'Amiens Pcardie - Hopital Sud Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| CH d'Auxerre Coordinator of this site? Confirm its status | Auxerre | France | Recruiting |
| Institut du Cancer Avignon - Institut Sainte Catherine Coordinator of this site? Confirm its status | Avignon | France | Withdrawn |
| CH de Bayeux - Onconormandie Coordinator of this site? Confirm its status | Bayeux | France | Withdrawn |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Hôpital Beaujon - APHP Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Withdrawn |
| Institut de Cancérologie de Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| CH Eure Seine - Hopital d'Evreux Vernon Coordinator of this site? Confirm its status | Évreux | France | Not yet recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Withdrawn |
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| CHRU de Nancy - Hôpital de Brabois Adulte Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Withdrawn |
| Institut Mutualiste de Montsouris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| APHP Pitié Salpétrière Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Joseph Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Privé des Côtes d'Armor - SAS Coordinator of this site? Confirm its status | Plérin | France | Recruiting |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
| Institut Jean Godinot Coordinator of this site? Confirm its status | Reims | France | Recruiting |
| CHU de Reims Hôpital Robert Debré Coordinator of this site? Confirm its status | Reims | France | Recruiting |
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| CHU Rouen Hopital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| CH Saint Malo - Hôpital Broussais Coordinator of this site? Confirm its status | St-Malo | France | Recruiting |
| ICANS Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| CHU de Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.