RecruitingPhase 2NCT04861584

Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects

Phase II Study of Neoadjuvant Toripalimab with Gemcitabine-Cisplatin in Subjects with T2-4aN0M0 Bladder Cancer: GZZJU-2021NB


Sponsor

Zhujiang Hospital

Enrollment

41 participants

Start Date

Jun 3, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an immunotherapy drug (toripalimab) with chemotherapy (gemcitabine and cisplatin) given before surgery in people with locally advanced bladder cancer, to see if this approach shrinks the tumor and makes surgery more successful. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced bladder cancer confirmed by biopsy (stage cT2–T4a) - You are planning to have a radical cystectomy (complete bladder removal) - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You are not a candidate for bladder removal surgery - Your general health is too poor for chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin

4 cycle neoadjuvant therapy and radical cystectomy


Locations(1)

Zhujiang Hospital

Guangzhou, Guangdong, China

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NCT04861584


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