Health TrialsbyHealthPanel

Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC

ConditionMuscle Invasive Bladder Cancer (MIBC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFujian Medical University Union Hospital

About this trial

This is a multicenter, open-label, prospective, single-arm, phase II study designed to evaluate the efficacy and safety of neoadjuvant zanidatamab combined with tislelizumab and chemotherapy, followed by selective bladder preservation, in patients with HER2-positive muscle-invasive bladder cancer (MIBC) staged cT2-4aN0-1M0.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment schedule.

Age 18 to 85 years on the date of informed consent.

Residual disease after TURBT; histologically confirmed urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 per AJCC 8th edition by histology and imaging. For mixed histology, urothelial carcinoma must be predominant (≥50%).

Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.

Disqualifiers

Pregnant or breastfeeding women.

Uncontrolled infection requiring systemic therapy.

Diagnosis of another malignancy within the past 5 years.

Major surgery or significant trauma within 28 days prior to enrollment (placement of a vascular access device and TURBT are not considered major surgery).

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanidatamab

    Drug

    Zanidatamab (1,800 mg for patients \<70 kg or 2,400 mg for patients ≥70 kg, administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant regimen. After completion of neoadjuvant therapy, disease status is reassessed. Patients achieving a clinical complete response (cCR) may continue zanidatamab every 3 weeks for 2-4 cycles as part of bladder-preserving treatment; those without cCR may receive radiotherapy or partial cystectomy followed by zanidatamab every 3 weeks for 2-4 cycles, or undergo radical cystectomy without further zanidatamab treatment.

  • Tislelizumab

    Drug

    Tislelizumab (200 mg administered intravenously every 3 weeks) is administered for 4 cycles as neoadjuvant therapy. After completion of 4 cycles, disease status is reassessed. Patients achieving a clinical complete response (cCR) may proceed with selective bladder preservation and continue tislelizumab every 3 weeks for 12 cycles; those without cCR may receive radiotherapy or partial cystectomy followed by tislelizumab every 3 weeks for 12 cycles, or undergo radical cystectomy with adjuvant tislelizumab every 3 weeks for 12 cycles.

  • Cisplatin

    Drug

    Cisplatin (70 mg/m² administered intravenously every 3 weeks ) for 4 cycles is included in the neoadjuvant chemotherapy regimen for eligible cisplatin-based chemotherapy.

  • Gemcitabine

    Drug

    Gemcitabine (1,000 mg/m² administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant chemotherapy regimen for eligible cisplatin-based chemotherapy.

  • Nab-paclitaxel

    Drug

    Nab-paclitaxel (125 mg/m² administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant chemotherapy regimen for ineligible or refused cisplatin-based chemotherapy.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Clinical Complete Response (cCR) Rate

Proportion of participants achieving cCR at the end of neoadjuvant therapy, defined as no evidence of tumor on radiographic imaging, no residual tumor on diagnostic TURBT, and negative urine cytology

Time frame
At the end of Cycle 4 of neoadjuvant therapy (each cycle is 21 days)

Secondary outcomes

1

1-Year Bladder-Intact Disease-Free Survival (BI-DFS)

Percentage of participants who, within 12 months from the first neoadjuvant dose, have no local or regional recurrence, no distant metastasis, no bladder cancer-related death, and have not undergone radical cystectomy

Time frame
From first neoadjuvant dose to 12 months
2

2-Year Bladder-Intact Disease-Free Survival (BI-DFS)

Percentage of participants who, within 24 months from the first neoadjuvant dose, have no local or regional recurrence, no distant metastasis, no bladder cancer-related death, and have not undergone radical cystectomy

Time frame
From first neoadjuvant dose to 24 months
3

Local Recurrence Free Survival (LRFS)

Time from the first neoadjuvant dose to local recurrence or death from any cause; participants without an event will be censored at last follow-up

Time frame
From first neoadjuvant dose until event, assess up to 3 years
4

Distant Metastasis Free Survival (DMFS)

Time from the first neoadjuvant dose to distant metastasis or death from any cause; participants without an event will be censored at last follow-up

Time frame
From first neoadjuvant dose until event, assess up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Medical University Union Hospital

Lead sponsor

BeiGene

Collaborator

Source ClinicalTrials.gov
Apply now