Promising combo aims to shrink bladder tumors before surgery
NCT ID NCT07639983
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining two drugs (trastuzumab rezetecan and camrelizumab) before surgery can improve outcomes for people with a certain type of muscle-invasive bladder cancer (HER2-positive). About 44 adults will receive the treatment to see if it helps eliminate cancer cells or shrink tumors enough to avoid bladder removal. The goal is to find a more effective and tolerable option than standard chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged ≥18 years old with no restriction on gender. 2. Voluntarily participate in this trial, sign written informed consent form and have good treatment compliance. 3. Histopathologically confirmed bladder urothelial carcinoma (carcinoma with squamous/glandular differentiation is acceptable only when urothelial component dominates the lesion). 4. Clinically or radiologically diagnosed muscle-invasive bladder cancer (MIBC): cT2-T4a, N0-1, M0 per AJCC/UICC staging system; all imaging assessments shall be completed within 28 days prior to enrollment. 5. HER2-positive tumor defined as IHC 1+, 2+ or 3+ tested on archival tumor specimen before enrollment via designated or central laboratory. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Candidates eligible for radical surgery: planned to receive radical cystectomy (RC), and investigators confirm feasibility of subsequent TURBT consistent with study protocol. 8. Satisfactory major organ function to tolerate perioperative treatment: * Hematology: ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; * Liver function: ALT/AST ≤2.5×ULN, total bilirubin ≤1.5×ULN; * Renal function: creatinine clearance ≥50 mL/min calculated by Cockcroft-Gault or MDRD formula; * Cardiac function: LVEF ≥50% detected by echocardiography without symptomatic heart failure (due to trastuzumab-related cardiac risk). 9. Fertile subjects agree to use effective contraception throughout study period and for defined duration after last study drug administration. Exclusion Criteria: 1. Patients with distant metastasis (M1), unresectable disease ineligible for radical surgery, or concomitant active malignancy requiring systematic anti-tumor therapy as assessed by investigator. 2. Prior systemic anti-tumor therapy for current bladder cancer, including neoadjuvant/adjuvant/metastatic chemotherapy, immunotherapy or anti-HER2 agents; previous exposure to PD-1/PD-L1 inhibitors, anti-HER2 monoclonal antibodies or ADCs that may interfere with efficacy or safety evaluation per investigator's judgment. 3. Previous pelvic radiotherapy, or unrecovered major surgery/severe trauma within predefined time window before enrollment. 4. Active autoimmune disease or patients requiring long-term systemic immunosuppressive therapy (daily prednisone\>10 mg or equivalent dose; topical/inhaled/short-course steroid use is permitted). 5. Uncontrolled active or severe bacterial infection, active tuberculosis; viral infection: HBsAg positive with elevated HBV DNA without standardized antiviral treatment, positive HCV RNA without disease control, or confirmed HIV infection per local institutional standard; clinically significant cardiovascular disorders including congestive heart failure, recent myocardial infarction, unstable angina, uncontrolled arrhythmia, baseline LVEF\<50%, or subjects inappropriate for trastuzumab administration judged by investigator. 6. Previous or ongoing interstitial lung disease/non-infectious pneumonitis, or obvious interstitial pulmonary changes on imaging with high risk of immune-related pneumonitis assessed by investigator. 7. Known severe hypersensitivity to trastuzumab, camrelizumab or any excipients of investigational drugs; pregnant or breastfeeding females, or those planning pregnancy throughout study period. 8. Severe psychiatric/cognitive disorder or substance abuse preventing regular follow-up and efficacy assessment. 9. Any other conditions inappropriate for trial enrollment such as severe comorbidities or extremely short expected survival, as determined by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HER2-positive muscle-invasive bladder cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill target cancers with a specific gene flaw?
- A simple blood draw could spot bladder Cancer's return
- Bladder preservation: a viable alternative to radical surgery?
- Could an ALS drug clear the fog of chemo brain?
- New drug duo aims to wipe out bladder tumors before surgery
- New bladder cancer combo shows promise in Pre-Surgery trial