Early Phase 1 Pancreatic Cancer Trial, Recruiting NCT05916261 Sponsor: Ruijin Hospital Condition: Pancreatic Cancer
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Early Phase 1 Pancreatic Cancer Trial, Recruiting

NCT05916261
Recruiting Early Phase 1

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 voluntarily agreed to take part and are willing and able to follow the study's procedures, as judged by the research team
  • People who are 18 years of age or older at the time of signing the consent form, of any gender
  • People who have been diagnosed with locally advanced, returning, or spread (metastatic) solid tumour cancer confirmed by laboratory testing within the past 6 months, and whose cancer has not responded to standard treatments or who are not currently suitable for standard treatments
  • People whose genetic testing shows no specific changes (copy number variations or loss of heterozygosity) in certain immune-related genes (HLA-related genes and chromosomal regions)
  • People whose tumour tissue has been tested and found to have at least one specific mutation (such as in KRAS or TP53 genes) that matches their immune system type (HLA type) in a way that may allow the body to recognise it, and who have enough preserved tumour tissue available for advanced genetic testing
  • People who are expected to live for at least 4 months
  • People who have at least one tumour that can be measured on scans, according to standard measurement guidelines (RECIST 1.1)
  • People who are in relatively good general health, rated 0 or 1 on a standard medical scale that measures how much cancer affects daily functioning (ECOG Performance Scale)
  • People whose blood tests show their organs and bone marrow are working well enough, and who have not received certain blood-boosting treatments or transfusions in the 14 days before testing
  • People who are able to use reliable contraception (hormonal, barrier methods, or abstinence) throughout the trial and for at least 90 days after the last dose; women of childbearing age must also have a negative blood pregnancy test within 7 days before the first dose
  • People whose virus tests at the start of the study show no active infection with CMV, EBV, HIV, hepatitis B (HBV), hepatitis C (HCV), or syphilis

Who may not be able to join:

  • People who have received chemotherapy, hormone therapy, traditional Chinese medicine for cancer, or other biological cancer therapies within 4 weeks before the first dose; or within 6 weeks for certain specific drugs (mitomycin and nitrosoureas); or within 5 half-lives for immunotherapy or targeted therapy
  • People who have had major surgery (other than a biopsy or diagnosis of their current tumour) within 4 weeks before the first dose, or who are expected to have major surgery during the study
  • People who have previously had a bone marrow or organ transplant, or who plan to have an organ transplant during the study
  • People who have previously received any other cancer vaccine or cell-based therapy
  • People who have cancer that has spread to the brain or spinal cord and is causing symptoms or is not well controlled, as judged by the research team
  • People who have another known cancer that is currently growing or requires active treatment (except for certain curable skin cancers, superficial bladder cancer, or cervical carcinoma in situ that have been successfully treated with surgery)
  • People who have a history of lung scarring conditions such as interstitial lung disease or pulmonary fibrosis
  • People with a history of serious heart or blood vessel problems, including certain abnormal heart rhythms, significant heart blockages, an abnormal heart electrical measurement (QTc interval above specific thresholds), a recent major heart or stroke event within 6 months, or significant heart failure or reduced heart pumping function
  • People with other serious or uncontrolled health conditions, including a history of severe allergic reactions to any relevant medication, immune system deficiencies (including HIV), severe liver or kidney disease, uncontrolled high blood pressure or diabetes, active stomach or bowel ulcers or bleeding, a serious infection requiring intravenous antibiotics or hospitalisation within the past 4 weeks, or active syphilis
  • People who have participated in another clinical trial within 4 weeks before the first dose
  • People currently taking systemic steroid medications (inhaled steroids may be acceptable — confirm with trial site)
  • People who are pregnant or breastfeeding
  • People whose scans show the tumour is growing into major blood vessels with a risk of bleeding
  • People with significant thyroid problems that the research team judges make participation unsuitable
  • People found to have active pneumonia on a chest scan during the screening period
  • People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen that requires repeated draining
  • People who still have side effects from previous cancer treatments that have not recovered to a mild level (grade 1 or lower on a standard medical scale), except for hair loss
  • People with certain active hepatitis B or hepatitis C virus levels detected in blood tests above normal limits
  • People who the research team considers unsuitable for any other reason

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Baiyong Shen, M.D.&Ph.D, Ruijin Hospital

Phone: 18817821319

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
Early Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
26 April 2023
Est. completion
30 November 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Maximum tolerated dose (MTD) or Dose-limiting toxicity(DLT),If MTD is not reached, Biologically Effective Dose (BED); Reaction of antigen-specific T cells in peripheral blood; Objective response rate (ORR); Disease control rate (DCR)

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