Phase 2 Colorectal Cancer Trial, Recruiting NCT06245356 Sponsor: UNICANCER Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06245356
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have given written consent before any trial procedures begin (if someone is physically unable to sign, a trusted person of their choice may confirm consent in writing on their behalf)
  • People with a confirmed diagnosis of adenocarcinoma of the colon, rectum, lower oesophagus, gastroesophageal junction, or stomach, based on tissue or cell testing
  • People whose colorectal or gastroesophageal cancer has spread to other parts of the body (either at the time of first diagnosis or after)
  • People who have at least one tumour that can be measured on scans, according to standard criteria
  • People who have not yet received any treatment for their metastatic (spread) cancer
  • People with a known enzyme deficiency called DPD deficiency, confirmed by a specific blood test showing elevated uracil levels (confirm with trial site for exact testing requirements)
  • People aged 18 or older
  • People who are reasonably active and able to care for themselves, with only mild limitations on physical activity (confirm with trial site)
  • People whose bone marrow, kidney, and liver are functioning well enough, as shown by blood tests taken within 7 days before treatment starts — including adequate blood cell counts, kidney function, liver enzyme levels, and blood clotting measures (confirm with trial site for specific values)
  • Women who could become pregnant must have a negative pregnancy blood test within 7 days before treatment starts
  • Women who could become pregnant, and men, must agree to use effective contraception throughout the trial and for up to 7 months after treatment ends
  • People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures
  • People who are affiliated with the Social Security System or an equivalent scheme

Who may not be able to join:

  • People who have had a different type of cancer within the past 5 years, except for certain treated cancers such as cervical cancer in situ, non-melanoma skin cancer, or very early-stage bladder cancer
  • People who have received radiotherapy within 28 days before the first dose of treatment
  • People with certain active heart conditions, including moderate-to-severe heart failure, severe unstable chest pain (angina at rest), or a heart attack within the past 12 months
  • People with high blood pressure that remains uncontrolled despite treatment
  • People with an active infection of moderate severity or worse
  • People with a known history of HIV infection
  • People with chronic hepatitis B or C infection
  • People who take medication to control seizures
  • People with brain or meningeal (brain lining) tumours that are causing symptoms
  • People who have had an organ transplant
  • People with a known allergy or sensitivity to any of the study drugs or their ingredients
  • People planned to receive oxaliplatin who already have nerve damage (numbness, tingling) beyond mild levels
  • People planned to receive bevacizumab who have had major surgery, an open biopsy, or a significant injury within 28 days before the first dose
  • People planned to receive bevacizumab who have a history of any bleeding disorder, or who have had a significant bleeding event within 4 weeks before starting treatment
  • People planned to receive trastuzumab, panitumumab, or bevacizumab who have active lung inflammation (interstitial lung disease) with ongoing symptoms
  • People who are unable to swallow oral (tablet/capsule) medication
  • People with an uncontrolled condition that prevents proper absorption of food or medication
  • People who are pregnant or breastfeeding
  • People who are unable or unwilling to attend the required medical follow-up, for any geographic, personal, medical, or psychological reason, or for any reason the trial doctor believes would interfere with safe participation
  • People who have taken part in another clinical trial using an investigational treatment within the past 30 days
  • People who have a close personal or professional relationship with the trial site or investigator
  • People who are under legal guardianship, protective custody, or who have limited or no legal capacity

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Emmanuelle SAMALIN, MD, Institut du Cancer de Montepllier

Phone: +33(0)6 68 32 03 59

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
UNICANCER
Registry
ClinicalTrials.gov
Start date
21 March 2025
Est. completion
22 October 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Treatment specific safety

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov