Actively Recruiting
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
Led by Peking University First Hospital · Updated on 2025-12-15
60
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary enrollment and signing of written informed consent
- Age 18 years or older, any gender
- Pathologically confirmed UTUC with at least one of: pT2 with high-risk factors, pT3 to pT4, or lymph node positive (pN+)
- Cisplatin intolerance or not receiving platinum-based adjuvant therapy
- No recurrent metastasis confirmed by imaging within 4 weeks after surgery
- HER2 immunohistochemistry (IHC) results of 3+ or 2+ confirmed
- Expected survival time of 6 months or more
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1
- Normal major organ function based on blood tests, liver function, kidney function, and coagulation parameters
You will not qualify if you...
- History of other malignancies except certain treated or non-aggressive cancers
- Prior allogeneic stem cell or organ transplant
- Anti-tumor systemic therapy within 4 weeks before this study or unresolved adverse events from prior therapy
- Congenital or acquired immunodeficiency disease
- Active or past autoimmune or inflammatory diseases requiring treatment
- Recent or planned systemic immunosuppressive medication beyond allowed exceptions
- Known hypersensitivity to vedicilumab or similar drugs
- Thrombosis or thromboembolic events within 6 months
- High risk of severe bleeding or recent significant bleeding events
- Significant cardiovascular disease or uncontrolled hypertension
- Other serious clinical or laboratory abnormalities affecting safety
- Active serious infections including HIV, hepatitis B or C, tuberculosis
- Not recovered from surgery or with serious postoperative complications
- Pregnant or breastfeeding women, or those unwilling to use effective contraception
- Other conditions judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
X
Xuesong Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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