MedTrace Logo

Multi-Omics-Based Phase Ⅱ Trial of Trastuzumab Rezetecan Plus Camrelizumab for Perioperative Therapy in HER2-Positive Muscle-Invasive Urothelial Carcinoma

NCT07639983 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-06-10

No results posted yet for this study

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 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.

Conditions

  • Muscle-Invasive Bladder Cancer (MIBC)
  • Urinary Bladder Cancer

Interventions

DRUG

Trastuzumab Rezetecan plus Camrelizumab

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.

Sponsors & Collaborators

  • Sheng Tai

    lead OTHER

Principal Investigators

  • Sheng Tai · The First Affiliated Hospital of Anhui Medical University

  • Hanjiang Xu · The First Affiliated Hospital of Anhui Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-05
Primary Completion
2028-06-05
Completion
2028-12-31

More Related Trials

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 NCT07639983 on ClinicalTrials.gov