Not Yet RecruitingPhase 2

Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer

58 participantsStarted 2026-06-01

Plain-language summary

This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 years.
. ECOG performance status of 0 or 1.
. Histopathologically diagnosed muscle-invasive bladder cancer (MIBC) (cT2-T4a, N0-1, M0).
. Tumor tissue with HER2 expression (IHC 2+ or 3+) and suitable for radical cystectomy (RC) and transurethral resection of bladder tumor (TURBT).
. No prior systemic chemotherapy.
. At least one measurable lesion per RECIST v1.1 (spiral CT long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm) before diagnostic surgery.
. Adequate organ function (no transfusion or hematopoietic growth factor within 2 weeks before blood count screening):
. Females of childbearing potential must agree to abstain from heterosexual intercourse or use reliable, effective contraception from signing informed consent until at least 120 days after the last dose of study drug; serum HCG must be negative within 7 days before starting study treatment; and must be non-lactating.

Exclusion criteria

. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.); patients with vitiligo; patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention are excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pathological Complete Response

Timeframe: Assessed post-surgery (radical cystectomy or TURBT) on resected tumor specimens after neoadjuvant therapy. Measured postoperatively, up to approximately 4 months after treatment start.

Trial details

NCT IDNCT07624201

SponsorHarbin Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

Yangyang Xu, M.D.

+8617703600131 602037@hrbmu.edu.cn

View on ClinicalTrials.gov More Muscle-Invasive Bladder Cancer (MIBC) trials