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A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.

NCT06630871 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-10

No results posted yet for this study

Summary

This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+.

Conditions

Interventions

DRUG

Distitamab Vedotin in combination with Tislelizumab

On the day after the initial TURBt procedure, use trastuzumab (200mg)+ Distitamab Vedotin (120mg \[≤ 60Kg\] or 2.0mg/Kg \[\>60Kg\]) every 3 weeks (Q3W). Simultaneously arrange for the patient to complete a second TURBt within 6 weeks, and continue to use 3 courses of Trastuzumab+Vediximab (Q3W) after surgery until the endpoint of 3-year follow-up

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • RemeGen Co., Ltd.

    collaborator INDUSTRY

  • Fujian Medical University Union Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-10-31
Completion
2028-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06630871 on ClinicalTrials.gov