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RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients

NCT07100184 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-03

No results posted yet for this study

Summary

This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT). The study plans to enroll 30 patients with high or very high risk HER2-expression NMIBC without visible lesions after TURBT. The study includes a screening period, a treatment period, and a survival follow-up period. This is a single-center study conducted at the Peking University First Hospital, and the PI is Prof. CuiJian Zhang.

Conditions

  • HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT

Interventions

DRUG

Disitamab Vedotin combined with Radiotherapy

Disitamab Vedotin (RC-48) injection 2mg/kg, Q2w for 4 circles before radiotherapy and 2mg/kg, Q3w for 8 circles after radiotherapy; Radiotherapy (Whole bladder dose: 25 Gy in 5 doses, QD)

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    collaborator INDUSTRY

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-05-31
Completion
2028-12-31

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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 NCT07100184 on ClinicalTrials.gov