Phase 2 Pancreatic Cancer Trial, Recruiting NCT06454448 Sponsor: Tianjin Medical University Cancer Institute and Hospital Condition: Pancreatic Cancer
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Phase 2 Pancreatic Cancer Trial, Recruiting

NCT06454448
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 aged 18 to 75 years old, of any gender
  • People who have been confirmed through a biopsy or cell sample to have pancreatic cancer that started in the ductal lining of the pancreas, and whose cancer has spread to other parts of the body (stage IV)
  • People who have not yet received any cancer treatment, such as chemotherapy, targeted therapy, or immunotherapy
  • People who have at least one measurable area of cancer that can be tracked during the trial (as determined by standard imaging guidelines), which has not been treated with radiation — or if it has, there is confirmed evidence the cancer has grown there since
  • People with a general health/activity level rated as 0 or 1 on a standard medical scale, meaning they are either fully active or can carry out light work (confirm with trial site)
  • People whose doctors estimate they are likely to live for at least 3 more months
  • People whose blood test results show that key organs — including the blood, liver, kidneys, and heart — are functioning well enough to meet specific levels set by the trial (confirm with trial site for exact values)
  • People whose heart is pumping at least 50% of its capacity, as measured by an ultrasound
  • People whose heart rhythm is within an acceptable range on an electrocardiogram (ECG)
  • Women who could become pregnant must have a negative blood pregnancy test within 3 days before joining, and must agree to use reliable contraception during the trial and for 6 months after finishing treatment
  • Men must either have had a surgical sterilisation procedure or agree to use reliable contraception during the trial and for 3 months after finishing treatment
  • People who are willing to participate and have signed a consent form agreeing to take part

Who may not be able to join:

  • People whose pancreatic cancer did not start in the ductal lining — for example, those with pancreatic neuroendocrine carcinoma, pancreatoblastoma, or solid-pseudopapillary tumours
  • People whose cancer has spread to the brain or central nervous system
  • People with serious digestive problems such as gastrointestinal bleeding, blockage, significant inflammation, or more than mild diarrhoea
  • People who have a significant build-up of fluid in body cavities such as the chest, that cannot be kept stable without ongoing drainage — within 2 weeks before joining
  • People who have fluid in the abdomen (ascites) causing symptoms that require draining, or who have had it drained in the past 3 months (small amounts shown only on imaging with no symptoms may still be eligible — confirm with trial site)
  • People who currently have, or have previously had, a serious lung condition such as interstitial lung disease, pulmonary fibrosis, drug-related lung inflammation, or active tuberculosis
  • People who have an active autoimmune disease, or a history of one that may return — such as autoimmune hepatitis, vasculitis, or inflammatory bowel disease (some conditions that are well-controlled, such as thyroid conditions managed with hormone replacement, type 1 diabetes managed with insulin, or childhood asthma that has fully resolved, may still be eligible — confirm with trial site)
  • People with severe nerve damage in their hands or feet (peripheral neuropathy rated grade 3 or higher on a standard medical scale)
  • People who have had a serious infection — such as severe pneumonia or a bloodstream infection — within 4 weeks before joining, or who needed intravenous antibiotics for an infection within 2 weeks before joining
  • People who have received immune-suppressing steroid medications at doses above a certain level within 2 weeks before joining
  • People who have had radiation therapy within 2 weeks before joining
  • People who have had major surgery, such as open chest or abdominal surgery, within 4 weeks before joining
  • People who have received another experimental treatment as part of a different clinical trial within 4 weeks before joining
  • People with abnormal blood clotting, a tendency to bleed, or who are currently receiving thrombolytic or anticoagulant (blood-thinning) therapy (low-dose aspirin and certain low-dose blood thinners may be allowed — confirm with trial site)
  • People with poorly controlled heart conditions, including significant heart failure, unstable chest pain (angina), a heart attack within the past 6 months, or serious heart rhythm problems requiring treatment
  • People who have had another type of cancer in the past 5 years, except for certain treated skin cancers or cervical carcinoma in situ
  • People who are known to be allergic to any of the study drugs: a PD-L1 inhibitor, albumin-bound paclitaxel, gemcitabine, or decitabine
  • People known to have HIV/AIDS, a positive HIV test, or an active syphilis infection
  • People with a confirmed history of a significant neurological or psychiatric condition, such as epilepsy or dementia
  • People who, in the opinion of the trial doctor, have other circumstances that may make it unsafe or impractical for them to complete the trial

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.

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Registry
ClinicalTrials.gov
Start date
15 June 2024
Est. completion
1 June 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose Limiting Toxicity (DLT); The recommended phase 2 dose (RP2D); Objective Response Rate (ORR)

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