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A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery

NCT06210490 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-15

No results posted yet for this study

Summary

In this study, 60 patients with HER2 overexpression UTUC with high-risk recurrence factors after radical surgery were proposed to be enrolled, and were assigned to Cohort I (receiving adjuvant therapy group) and Cohort II (refusing to receive adjuvant therapy group) according to the subjects' wishes. Cohort I subjects were treated with vedicloxacinumab in combination with radiotherapy, and vedicloxacinumab treatment lasted for 6 months. Cohort II subjects receive close observation and best supportive care. Safety evaluations and efficacy evaluations will be performed during the study period. Safety Evaluations: Safety evaluations will be conducted within 3 days prior to each dose and will continue until 30 days after the last study dose or initiation of new antitumor therapy for subjects who have received at least one dose of study drug. Evaluation of effectiveness: effectiveness evaluations will be conducted every 12 weeks (±3 days) until imaging-confirmed tumor recurrence, subject death, withdrawal of informed consent, loss to follow-up, or study termination, whichever occurs first. Tumor assessment was performed according to the Criteria for Evaluation of Efficacy in Solid Tumors (RECIST v1.1). For subjects with disease progression, postoperative tumor recurrence, or initiation of other antitumor therapy, survival follow-up was performed every 3 months (window period ± 14 days) from the date of notification to collect information on the subject's subsequent antitumor therapy and survival until the subject's death, withdrawal of informed consent, loss of visit, or study termination, whichever occurred first.

Conditions

  • Upper Urinary Tract Urothelial Carcinoma

Interventions

DRUG

Disitamab Vedotin

Disitamab vedotin (RC48-ADC) is a novel humanized anti-human epidermal growth factor receptor 2 (HER2) antibody conjugated with monomethyl auristatin E via a cleavable linker. Two phase II studies, RC48-C005 (NCT03507166) and RC48-C009 (NCT03809013), have shown its significant antitumor potential in patients with la/mUC with HER2 overexpression (immunohistochemistry (IHC) 3+ or 2+). In 2022, RC48-ADC was approved for patients with HER2 overexpressing la/mUC who had received prior chemotherapy in China.

RADIATION

Radiotherapy

Radiotherapy dose: 45-50 Gy/25f/5w to lymph node drainage area; 62.5 Gy/25f/5w to metastatic or suspected metastatic lymph nodes.

OTHER

Standard of Care

Standard of Care

Sponsors & Collaborators

  • Peking University First Hospital Miyun Hospital

    collaborator UNKNOWN

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • China

Study Locations

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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 NCT06210490 on ClinicalTrials.gov