Muscle-Invasive Bladder Cancer (MIBC)Phase 2NCT07639983
Multi-Omics-Based Phase Ⅱ Trial of Trastuzumab Rezetecan Plus Camrelizumab for Perioperative Therapy in HER2-Positive Muscle-Invasive Urothelial Carcinoma
A Phase 2 study testing Trastuzumab Rezetecan plus Camrelizumab in people with Muscle-Invasive Bladder Cancer (MIBC) and Urinary Bladder Cancer, run by Sheng Tai.
Trial summary
For patients with HER2-expressing muscle-invasive bladder cancer (MIBC), current neoadjuvant therapies dominated by platinum-based chemotherapy remain unsatisfactory with respect to improved clinical efficacy, pathological complete response (pCR) rates, and the achievement rate of tumor downstaging for bladder… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Cancer (MIBC), Urinary Bladder Cancer
- What is being tested?
- Trastuzumab Rezetecan plus Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years old with no restriction on gender.
- Voluntarily participate in this trial, sign written informed consent form and have good treatment compliance.
- Histopathologically confirmed bladder urothelial carcinoma (carcinoma with squamous/glandular differentiation is acceptable only when urothelial component dominates the lesion).
- 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.
- HER2-positive tumor defined as IHC 1+, 2+ or 3+ tested on archival tumor specimen before enrollment via designated or central laboratory.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
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- Candidates eligible for radical surgery: planned to receive radical cystectomy (RC), and investigators confirm feasibility of subsequent TURBT consistent with study protocol.
- 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).
- Fertile subjects agree to use effective contraception throughout study period and for defined duration after last study drug administration.
Who cannot join
- Patients with distant metastasis (M1), unresectable disease ineligible for radical surgery, or concomitant active malignancy requiring systematic anti-tumor therapy as assessed by investigator.
- 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.
- Previous pelvic radiotherapy, or unrecovered major surgery/severe trauma within predefined time window before enrollment.
- 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).
- 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.
- 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.
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- Known severe hypersensitivity to trastuzumab, camrelizumab or any excipients of investigational drugs; pregnant or breastfeeding females, or those planning pregnancy throughout study period.
- Severe psychiatric/cognitive disorder or substance abuse preventing regular follow-up and efficacy assessment.
- Any other conditions inappropriate for trial enrollment such as severe comorbidities or extremely short expected survival, as determined by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase Ⅱ Clinical Study on Predicting Perioperative Efficacy of Trastuzumab Rezetecan Combined With Camrelizumab in HER2-Positive Muscle-Invasive Urothelial Carcinoma Based on Multi-Omics
For patients with HER2-expressing muscle-invasive bladder cancer (MIBC), current neoadjuvant therapies dominated by platinum-based chemotherapy remain unsatisfactory with respect to improved clinical efficacy, pathological complete response (pCR) rates, and the achievement rate of tumor downstaging for bladder preservation; in addition, a subset of patients have limited tolerance or eligibility to chemotherapy. Therefore, this study aims to evaluate the neoadjuvant regimen of Ruikang Trastuzumab combined with Camrelizumab, to determine whether this regimen can, with acceptable safety profiles: elevate pCR rate and the proportion of patients downstaged to ≤T1 disease, enable bladder preservation based on TURBT for eligible patients, and explore predictive biomarkers to identify the population most likely to derive clinical benefits.
- Being tested
- Trastuzumab Rezetecan plus Camrelizumab
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Rezetecan plus CamrelizumabDrug
Eligible screened participants will receive assigned treatment after satisfying all inclusion/exclusion criteria.
Neoadjuvant Phase: Patients receive Trastuzumab Rezetecan (4.8 mg/kg, intravenous infusion) plus Camrelizumab (200 mg, intravenous infusion); each treatment cycle lasts 21 days, for a total of 2-3 cycles.
Following a 2-4 week rest interval, clinical reassessment is performed prior to radical cystectomy (RC).
Postoperative Adjuvant Phase: After surgery, Trastuzumab Rezetecan (4.8 mg/kg, IV infusion, once every 3 weeks for 6 cycles) and Camrelizumab (200 mg, IV infusion once every 3 weeks) are administered, with camrelizumab maintained for up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Therapy with Trastuzumab Rezetecan Combined with Camrelizumab | Experimental | Not described Receives: Drug: Trastuzumab Rezetecan plus Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response Rate (pCR rate)
Proportion of patients achieving pathological complete response (pCR, no residual invasive urothelial carcinoma in bladder and regional lymph nodes) in surgical specimen after perioperative neoadjuvant therapy.
Measured: Up to approximately 1 year
Secondary outcomes (4)
Event-Free Survival (EFS)
Time from study treatment initiation to first occurrence of local recurrence, distant metastasis, disease progression or all-cause death.
Measured: From treatment start until disease progression/death, follow-up up to 12 months.
Overall Survival (OS)
Time from study treatment initiation to all-cause death of any reason.
Measured: From treatment start until death, follow-up up to 12 months.
Safety and Tolerability
Incidence, severity and causality of adverse events (AEs) graded per CTCAE v6.0 throughout perioperative treatment period.
Measured: From first study drug administration to 30 days after last study medication.
Proportion of patients downstaged to T1 stage
Percentage of enrolled patients whose postoperative pathological tumor stage is downstaged to T1 after perioperative therapy.
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start5 Jun 2026 (estimated)
- Primary completion5 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder Cancer (MIBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheng Tai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng Tai, Anhui Medical University
- Investigators
- Sheng Tai, Principal investigator, The First Affiliated Hospital of Anhui Medical UniversityHanjiang Xu, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639983
- Sponsor's protocol ID
- KY2026-04-47 (1)
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Clinical Study on Predicting Perioperative Efficacy of Trastuzumab Rezetecan Combined With Camrelizumab in HER2-Positive Muscle-Invasive Urothelial Carcinoma Based on Multi-Omics
- ClinicalTrials.gov ID
- NCT07639983
- Acronym / sponsor ID
- KY2026-04-47 (1)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sheng TaiUniversity, hospital or other
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 5 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For patients with HER2-expressing muscle-invasive bladder cancer (MIBC), current neoadjuvant therapies dominated by platinum-based chemotherapy remain unsatisfactory with respect to improved clinical efficacy, pathological complete response (pCR) rates, and the achievement rate of tumor downstaging for bladder preservation; in addition, a subset of patients have limited tolerance or eligibility to chemotherapy. Therefore, this study aims to evaluate the neoadjuvant regimen of Ruikang Trastuzumab combined with Camrelizumab, to determine whether this regimen can, with acceptable safety profiles: elevate pCR rate and the proportion of patients downstaged to ≤T1 disease, enable bladder preservation based on TURBT for eligible patients, and explore predictive biomarkers to identify the population most likely to derive clinical benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perioperative Therapy with Trastuzumab Rezetecan Combined with Camrelizumab | Experimental | Drug: Trastuzumab Rezetecan plus Camrelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged ≥18 years old with no restriction on gender.
- Voluntarily participate in this trial, sign written informed consent form and have good treatment compliance.
- Histopathologically confirmed bladder urothelial carcinoma (carcinoma with squamous/glandular differentiation is acceptable only when urothelial component dominates the lesion).
- 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.
- HER2-positive tumor defined as IHC 1+, 2+ or 3+ tested on archival tumor specimen before enrollment via designated or central laboratory.
Key exclusion criteria (9 listed)
- Patients with distant metastasis (M1), unresectable disease ineligible for radical surgery, or concomitant active malignancy requiring systematic anti-tumor therapy as assessed by investigator.
- 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.
- Previous pelvic radiotherapy, or unrecovered major surgery/severe trauma within predefined time window before enrollment.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab Rezetecan plus CamrelizumabEligible screened participants will receive assigned treatment after satisfying all inclusion/exclusion criteria. Neoadjuvant Phase: Patients receive Trastuzumab Rezetecan (4.8 mg/kg, intravenous infusion) plus Camrelizumab (200 mg, intravenous infusion); each treatment cycle lasts 21 days, for a total of 2-3 cycles. Following a 2-4 week rest interval, clinical reassessment is performed prior to radical cystectomy (RC). Postoperative Adjuvant Phase: After surgery, Trastuzumab Rezetecan (4.8 mg/kg, IV infusion, once every 3 weeks for 6 cycles) and Camrelizumab (200 mg, IV infusion once every 3 weeks) are administered, with camrelizumab maintained for up to 1 year. | Drug | Perioperative Therapy with Trastuzumab Rezetecan Combined with Camrelizumab |
Primary outcome
Pathological Complete Response Rate (pCR rate)
Time frame: Up to approximately 1 year
Proportion of patients achieving pathological complete response (pCR, no residual invasive urothelial carcinoma in bladder and regional lymph nodes) in surgical specimen after perioperative neoadjuvant therapy.
4 secondary outcomes
Event-Free Survival (EFS)
Time frame: From treatment start until disease progression/death, follow-up up to 12 months.
Overall Survival (OS)
Time frame: From treatment start until death, follow-up up to 12 months.
Safety and Tolerability
Time frame: From first study drug administration to 30 days after last study medication.
Proportion of patients downstaged to T1 stage
Time frame: Up to approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheng Tai principal investigator
The First Affiliated Hospital of Anhui Medical University
Hanjiang Xu principal investigator
The First Affiliated Hospital of Anhui Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab Rezetecan plus Camrelizumab in people with Muscle-Invasive Bladder Cancer (MIBC) and Urinary Bladder Cancer, run by Sheng Tai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Tai, MD (+86-551-62922234, taisheng@ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response Rate (pCR rate) (time frame: Up to approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.