Phase 2 Bladder Cancer Trial, Recruiting NCT04861584 Sponsor: Zhujiang Hospital Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT04861584
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 are between 18 and 75 years old at the time of signing the consent form, regardless of gender
  • You are generally well enough to carry out daily activities with little or no limitation, and doctors expect you to live for more than 6 months
  • Tests have confirmed you have locally advanced bladder cancer (a specific type called urothelial carcinoma) that has not spread to distant parts of the body
  • You are considered a suitable candidate and are planning to have surgery to remove your bladder (radical cystectomy)
  • At least one area of cancer can be clearly measured on a CT scan
  • You have not received any cancer treatment through the bloodstream (such as chemotherapy or immunotherapy) since being diagnosed with this bladder cancer
  • Your blood test results show that your blood cells, kidneys, liver, and thyroid are all functioning within acceptable levels (checked within 2 weeks before starting the trial)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days of joining and agree to use reliable contraception during the trial and for 8 weeks after the last dose
  • You agree to provide tumour tissue samples for research purposes and to attend all planned appointments
  • You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • You have previously received certain types of immunotherapy (anti-PD1, PDL1, or CTLA-4 drugs) or chemotherapy given through the bloodstream (bladder wash-in chemotherapy does not count)
  • You have received a BCG bladder treatment within the last 4 weeks
  • You have previously had radiotherapy directed at your bladder
  • You have or have had an active autoimmune disease (a condition where the immune system attacks the body)
  • You need to take immunosuppressant medications, or have been taking steroid tablets above a low dose within 2 weeks before starting the trial
  • You currently have or have had another type of cancer at the same time
  • You have had an allergic reaction to any antibody-based drug in the past
  • You have a history of HIV infection
  • You currently have an active infection, including active tuberculosis
  • You have a serious heart condition, or your heart failure has been rated as severe by a doctor (confirm with trial site)
  • You have had a kidney transplant

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 21 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: Abai Xu, doctor, Zhujiang Hospital

Phone: +86 18665626790

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
Zhujiang Hospital
Registry
ClinicalTrials.gov
Start date
3 June 2021
Est. completion
3 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Pathological response rate evaluated after 4 cycles of neoadjuvant Toripalimab in combination with gemcitabine and cisplatin at time of radical cystectomy, each cycle is 21 days

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: 21 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