Phase 2 Colorectal Cancer Trial, Recruiting NCT06425133 Sponsor: Centre Hospitalier Universitaire de Besancon Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06425133
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 been diagnosed with colorectal cancer that has spread to other parts of the body (confirmed by a tissue test), and whose cancer has continued to grow after receiving standard treatments, or who are not suitable candidates for those treatments.
  • People with a life expectancy of at least 3 months.
  • People aged 18 years or older, of any gender.
  • People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
  • People whose cancer can be measured on a scan (CT or MRI) according to standard guidelines.
  • People whose blood counts, liver, and kidney functions fall within acceptable ranges as determined by blood and urine tests (confirm with trial site for specific values).
  • People who are able to receive iodine-based contrast dye during a CT scan (i.e., no known allergy or contraindication).
  • Women who could become pregnant must have a negative pregnancy test within 14 days before starting the study treatment, and both men and women must use adequate contraception during the study where applicable.
  • People who have read, understood, and signed an informed consent form before joining.
  • People who, in the opinion of the trial doctor, are able to follow the study schedule and requirements.
  • People who are registered with a national health care system.

Who may not be able to join:

  • People who have been diagnosed with another cancer within the past 2 years (except certain skin cancers or early-stage cervical or bladder cancers that have been fully treated).
  • People who are currently taking part in another clinical trial or are still within a required waiting period after a previous trial.
  • People facing personal, family, social, or geographical circumstances that could make it difficult to follow the trial schedule and requirements.
  • People who are under legal guardianship or whose personal freedom is restricted.
  • People who have previously been treated with the study drug regorafenib, or with certain other anti-cancer drugs that target blood vessel growth (other than bevacizumab or aflibercept).
  • People who have received another experimental treatment within 28 days before joining the trial (except aspirin).
  • People who are currently receiving, or have received within the past 3 weeks, other systemic cancer treatments such as chemotherapy, immunotherapy, hormone therapy, or targeted therapy.
  • People who regularly take certain medications that are known to interact with the study drugs, including some epilepsy medications or a specific antiviral drug called brivudine (confirm with trial site for the full list).
  • People who have a complete deficiency of a specific enzyme called DPD (dihydropyrimidine dehydrogenase), which affects how the body processes certain chemotherapy drugs.
  • People with a known allergy or serious reaction to any of the study drugs or their ingredients, including a history of severe reactions to a type of chemotherapy called fluoropyrimidines, aspirin-triggered asthma, or a rare condition called mastocytosis.
  • People who still have unresolved side effects (above a mild level) from previous cancer treatments, with some exceptions such as hair loss, an underactive thyroid, or mild nerve damage from a prior treatment.
  • People who are unable to swallow tablets or capsules, or who have a condition affecting the absorption of food or medication.
  • People with serious heart, lung, kidney, or other organ problems, including uncontrolled high blood pressure, recent heart attack (within 6 months), unstable chest pain, significant heart failure, serious lung disease, active infection, dehydration, fluid build-up causing breathing difficulty, or a blocked urinary tract.
  • People who have had significant bleeding events, bowel perforation, an abdominal abscess, a fistula, or active stomach or bowel bleeding within the past 4 to 6 months (timeframe depends on the specific condition — confirm with trial site).
  • People who have a serious unhealed wound, an active stomach ulcer, or an untreated broken bone.
  • People who have had major surgery, an open biopsy, or a significant injury within 28 days before starting the trial.
  • People who are expected to need surgery within the first month of treatment, or any procedure that could affect the timing of the study drug during that period.
  • People with a known history of HIV, or active or ongoing hepatitis B or C requiring antiviral treatment.
  • People who have received a yellow fever vaccine within 28 days before joining the trial.
  • People who have had an organ transplant.
  • People who are pregnant or currently breastfeeding.

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 12 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

Phone: +33 370632278

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
Centre Hospitalier Universitaire de Besancon
Registry
ClinicalTrials.gov
Start date
19 July 2024
Est. completion
1 September 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

To evaluate the impact of a Regorafenib combined with metronomic chemotherapy and low-dose aspirin compared to standard Regorafenib treatment by assessing progression-free survival

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: 12 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