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Monitoring targeted therapy drugs in patients with advanced digestive cancers

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

NA · UNICANCER · NCT05443087

This study is testing how to best monitor and adjust the doses of targeted therapy drugs for people with advanced digestive cancers to make sure they are safe and effective.

Quick facts

PhaseNA
Study typeInterventional
Enrollment330 (estimated)
Ages18 Years and up
SexAll
SponsorUNICANCER (other)
Drugs / interventionscetuximab, Sunitinib, Cabozantinib, chemotherapy, immunotherapy
Locations29 sites (Amiens and 28 other locations)
Trial IDNCT05443087 on ClinicalTrials.gov

What this trial studies

This study focuses on monitoring the plasma levels of various multikinase inhibitors in patients with advanced digestive cancers, including metastatic colorectal cancer, hepatocellular carcinoma, and neuroendocrine tumors. It is a multicenter, open-label interventional study that aims to determine the optimal dosage of these therapies tailored to individual patients. Blood samples will be collected at various intervals to build a pharmacokinetics model, ensuring that treatment is both effective and safe. The study will include multiple cohorts based on the specific type of cancer and treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with advanced digestive cancers who are eligible for standard treatment with specific multikinase inhibitors.

Not a fit: Patients with early-stage digestive cancers or those not eligible for the specified treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment plans for patients with advanced digestive cancers.

How similar studies have performed: Other studies have shown promise in targeted therapy monitoring, suggesting that this approach could yield beneficial results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient aged 18 years or over
2. 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
3. Life expectancy of greater than 3 months - at the discretion of the investigator
4. Measurable disease according to tumor evaluation criteria as per local practice (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)
5. Patients must be affiliated to a Social Security System (or equivalent)
6. 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.

Exclusion Criteria:

1. Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor hormone therapy or immunotherapy) than the one studied
2. Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and peripheral neuropathy
3. 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.
4. 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
5. 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.
6. 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
7. 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)
8. Patient deprived of their liberty or under protective custody or guardianship

Where this trial is running

Amiens and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Digestive Cancer, Metastatic Colorectal Cancer, Hepatocellular Carcinoma, GIST, Neuroendocrine Tumors, multi kinases inhibitors, therapeutic drug monitoring, pharmacokinetics

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.