Phase 2 Pancreatic Cancer Trial, Recruiting NCT05969171 Sponsor: Fudan University Condition: Pancreatic Cancer
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Phase 2 Pancreatic Cancer Trial, Recruiting

NCT05969171
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 voluntarily agreed to take part and have signed a consent form
  • People with pancreatic cancer that cannot be removed by surgery, or that has spread locally or to other parts of the body, confirmed by a tissue or cell sample test
  • People aged between 18 and 75 years old (inclusive), of any gender
  • People with a good general health performance score (ECOG 0–1) and an expected survival of at least 12 weeks
  • People who have already received exactly 2 cycles of a specific first-line chemotherapy combination (called the AG regimen) for their advanced or metastatic pancreatic cancer, and whose cancer responded by shrinking, staying stable, or not growing further (note: people whose cancer was assessed as "stable" but actually grew during those 2 cycles are not included)
  • People whose cancer came back as distant spread after surgery, who received one type of chemotherapy after surgery, and whose cancer returned more than 6 months after that post-surgery chemotherapy ended
  • People who have at least one tumour that can be measured on a scan, meeting specific size requirements on MRI or CT imaging
  • People with no serious diseases affecting the heart, lungs, brain, or other major organs
  • People whose blood counts, blood clotting, liver function, kidney function, and heart function all fall within the ranges required by the trial
  • People who are capable of having children and who agree to use effective contraception during the trial and for 6 months after the last dose of the study treatment

Who may not be able to join:

  • People who have taken part in another clinical trial of an anti-cancer drug within the 4 weeks before joining
  • People who have previously been treated with VEGFR inhibitors or immune checkpoint inhibitors
  • People who have a known inherited (germline) mutation in the BRCA1 or BRCA2 genes
  • People with a blocked bile duct (obstructive jaundice) that has not been sufficiently relieved by drainage procedures
  • People who have had another cancer within the past 5 years, except for certain skin cancers that were fully removed by surgery, or early-stage cervical cancer that has been treated
  • People who have had, or currently have, cancer that has spread to the brain
  • People where the doctors have determined that cancer in the liver makes up 70% or more of the total liver volume
  • People who had surgery (other than a biopsy) or an invasive procedure within the 4 weeks before joining, where the wound has not fully healed (routine procedures such as IV lines or drainage tubes are generally exempt — confirm with trial site)
  • People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires drainage
  • People who received certain local treatments to the liver (such as embolisation, freezing, or radiofrequency ablation of liver tumours) within the 4 weeks before joining
  • People with electrolyte levels in the blood that the doctors consider to be clinically significant abnormalities
  • People with high blood pressure that is not controlled by medication, defined as a reading of 140 mmHg or higher (top number) and/or 90 mmHg or higher (bottom number)
  • People whose urine tests show significant amounts of protein (2+ or more on a standard test, or more than 1.0g in a 24-hour urine collection)
  • People where the doctors judge that the tumour is at high risk of growing into a major blood vessel and causing dangerous bleeding
  • People with a significant history of bleeding within the past 3 months (such as coughing up blood, vomiting blood, black stools, or blood in stools), or a known inherited or acquired disorder affecting blood clotting
  • People with significant recent heart problems, including heart attack, severe chest pain, or heart bypass surgery within the past 6 months; moderate-to-severe heart failure; heart rhythm problems requiring medication; or a specific abnormal result on a heart electrical trace (ECG showing QTc interval of 480ms or more)
  • People with an active or poorly controlled serious infection
  • People still experiencing significant side effects from previous cancer treatments (above a certain severity level), with some exceptions for hair loss, low lymphocyte counts, and certain nerve-related side effects
  • People who are pregnant or breastfeeding
  • People with other medical conditions, abnormal test results, or physical issues that the doctors judge would make it unsafe to take part or would interfere with the trial results
  • People with known HIV infection, active hepatitis B virus infection (with high levels of virus in the blood), active hepatitis C virus infection (with detectable virus), or liver cirrhosis
  • People with an active autoimmune disease (a condition where the immune system attacks the body's own tissues), including but not limited to conditions such as lupus, rheumatoid arthritis, multiple sclerosis, autoimmune hepatitis, or similar conditions
  • People who are known or suspected to be allergic to the study drug or similar medicines
  • People with other factors that the doctors judge could affect safety or the reliability of results, such as alcohol dependence, drug misuse, serious mental health conditions, or significant social or family circumstances

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: Jin Xu, 180 1731 7267

Phone: 180 1731 7267

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
Registry
ClinicalTrials.gov
Start date
5 December 2023
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

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: 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