Phase 2 Pancreatic Cancer Trial, Recruiting NCT06538857 Sponsor: CEBIOTEX Condition: Pancreatic Cancer
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Phase 2 Pancreatic Cancer Trial, Recruiting

NCT06538857
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:

  • You must be 18 years old or older.
  • You must have been diagnosed with a specific type of pancreatic cancer (carcinoma, adenocarcinoma, or ductal adenocarcinoma) that is either locally advanced, resectable (able to be removed by surgery), or borderline resectable — confirmed by a lab test on a tissue sample (this can be done during surgery if needed, and a biopsy before surgery is not required).
  • If you have previously received chemotherapy, you may still be eligible as long as your cancer did not continue to grow or spread during that treatment.
  • Your cancer must be visible and measurable on at least one type of medical scan, such as an MRI, CT scan, PET scan, or ultrasound.
  • Your tumour(s) must be suitable for a specific type of surgery called a pancreatoduodenectomy (removal of part of the pancreas and nearby structures).
  • Your kidneys must be working well enough, based on blood test results meeting specific levels (confirm with trial site).
  • Your blood counts (red blood cells, platelets, and white blood cells) and heart function must meet certain minimum levels, which may be supported by a blood transfusion if needed (confirm with trial site).
  • Your liver must be functioning well enough, based on specific blood test results, and your bilirubin level must generally be at or below a certain threshold — a drainage procedure may be done beforehand if needed (confirm with trial site).
  • Any serious side effects from previous cancer treatments must have fully resolved before joining the trial.
  • If you received chemotherapy before surgery (neoadjuvant chemotherapy) for borderline or locally advanced disease, it must have been completed at least 4 weeks before your planned surgery.
  • You must be in good enough general health to carry out daily activities, rated as 0 or 1 on a standard fitness scale used by doctors (confirm with trial site).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the screening process.
  • If you or your partner could become pregnant, you must be willing to use reliable contraception throughout the study and for 6 months after surgery.
  • You (or your legal guardian) must sign a written consent form before any study procedures begin.

Who may not be able to join:

  • You have been diagnosed with another cancer in the past 2 years.
  • After surgery, visible cancer remains in the body (known as an R2 resection).
  • You have a specific inherited genetic variation (homozygous UGT1A1) that is known to increase the risk of serious side effects from certain chemotherapy drugs used in this trial (confirm with trial site).
  • You currently have an active bacterial, viral, or fungal infection.
  • You have a known history of HIV, hepatitis B, hepatitis C, or chronic liver disease.
  • It would not be possible to ensure you attend the required follow-up appointments during the study.
  • In the opinion of the trial doctors, you may not be able to follow the safety monitoring requirements of the study.
  • You are unable to have a CT scan for any reason.
  • You have had major surgery within the 14 days before starting the study treatment, or you are still recovering from surgical complications — note that a tumour biopsy or insertion of a central line does not count as major surgery.
  • You have other significant illnesses that the trial team considers relevant (confirm with trial site).
  • You have previously had an allogeneic stem cell transplant (a transplant using stem cells from a donor).
  • You have a serious condition affecting a major organ that could affect your ability to tolerate the treatment (confirm with trial site).
  • You are currently pregnant or breastfeeding — if you are breastfeeding, you would need to stop before joining.

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 19 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: Javier Padillo Ruiz, M.D.; Ph.D., H.U. Virgen del Rocío (Sevilla)

Phone: +34 93 434 44 12

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
CEBIOTEX
Registry
ClinicalTrials.gov
Start date
20 August 2024
Est. completion
1 September 2028

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Frequency of Adverse Events (AEs) (Safety); Frequency of surgical complications after pancreatic surgery

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: 19 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