Phase 2 Parkinson's Disease Trial, Recruiting NCT05281003 Sponsor: Fudan University Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT05281003
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:

  • Adults aged 18 or older who have been diagnosed with a specific type of oesophageal cancer called squamous cell carcinoma (ESCC) that is locally advanced and considered surgically removable, confirmed through laboratory testing of tumour tissue, and have not yet received any treatment for it.
  • Male participants who agree to use contraception during treatment and for at least 95 days after the last dose, and agree not to donate sperm during this period.
  • Female participants who are not pregnant and not breastfeeding, and who either are not able to become pregnant, or agree to use contraception during treatment and for at least 120 days after the last dose.
  • People who provide written consent to participate in the trial (or whose legal representative provides consent where applicable).
  • People who have measurable signs of disease that can be tracked using standard imaging guidelines (RECIST 1.1).
  • People who can provide a tumour tissue sample — either from existing stored tissue or a newly taken biopsy — from an area that has not previously been treated with radiation.
  • People who have a good general level of physical functioning, rated 0 or 1 on a standard medical scale (ECOG), assessed within 7 days before starting treatment.
  • People whose heart, liver, kidneys, and other organs are functioning well enough, confirmed by blood tests taken within 10 days before starting treatment.

Who may not be able to join:

  • Women of childbearing potential who have a positive pregnancy test within 72 hours before being assigned to the trial.
  • People who have previously been treated with certain types of immunotherapy drugs that target the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar agents).
  • People who have received any systemic cancer treatment, including experimental treatments, within 4 weeks before joining the trial.
  • People who have received radiation therapy within 2 weeks before starting the trial, or who have not yet recovered from radiation side effects, or who have had radiation-related lung inflammation.
  • People who have received a live or live-attenuated vaccine (such as some flu or shingles vaccines) within 30 days before the first dose.
  • People who are currently participating in, or have recently participated in, another clinical trial involving an experimental treatment or device within 4 weeks before the first dose.
  • People who have an immune system deficiency, or who are taking steroid medication at higher than a low daily dose, or any other medication that suppresses the immune system, within 7 days before the first dose.
  • People who have another cancer that is currently active or has required treatment within the past 2 years (though certain skin cancers or carcinomas in situ that have been successfully treated may still be eligible — confirm with trial site).
  • People who have active cancer that has spread to the brain or the lining of the brain, unless previously treated brain metastases have been stable for at least 4 weeks and steroid treatment has not been needed for at least 14 days.
  • People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
  • People who have an autoimmune disease that has required systemic medical treatment within the past 2 years (note: simple hormone replacement therapies, such as thyroid or insulin, are generally not considered a reason for exclusion — confirm with trial site).
  • People who have a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
  • People who have an active infection that requires treatment through the bloodstream or systemically.
  • People with a known history of HIV infection.
  • People with known active Hepatitis B or Hepatitis C infection.
  • People who have a medical condition, ongoing therapy, or abnormal test result that, in the treating doctor's judgement, could interfere with the trial or would not be in the person's best interest.
  • People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial's requirements.
  • People who are pregnant, breastfeeding, or planning to conceive or father a child during the trial period and up to 120 days after the last dose.
  • People who have previously received an organ or tissue transplant from another person.

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 28 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: Haiquan Chen, M.D., Ph.D., Fudan University

Phone: (86)13601973588

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
20 February 2023
Est. completion
1 September 2023

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Pathologic complete response (pCR) rate in all eligible participants with locally advanced ESCC; Major hypoxia signals in baseline or post-treatment tumor samples from all eligible participants with locally advanced ESCC

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: 28 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