Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma.
Xinan Sheng, Xieqiao Yan, Lin Wang...
https://pubmed.ncbi.nlm.nih.gov/33109737Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06210490
Efficacy and Safety of Disitamab Vedotin Combined With Radiotherapy for HER2 Overexpressing UTUC Patients With High Risk of Recurrence After Surgery
Led by Peking University First Hospital · Updated on 2025-12-15
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the safety and effectiveness of disitamab vedotin combined with radiotherapy for patients with upper urinary tract urothelial carcinoma (UTUC) who have high-risk factors for recurrence after radical surgery. The study involves 60 patients with HER2 overexpression and aims to evaluate disease-free survival and other outcomes over time. Patients are grouped based on their choice to receive adjuvant therapy or to undergo close observation with supportive care. Patients in the adjuvant therapy group receive disitamab vedotin, a targeted drug, alongside radiotherapy. The radiotherapy dose targets lymph node areas and metastatic sites over a 5-week period. The disitamab vedotin treatment lasts for 6 months. Those in the non-adjuvant group do not receive this therapy but are closely monitored. Safety and effectiveness assessments continue throughout the study, including follow-up after treatment completion. Participants will have regular safety checks before each treatment dose and for 30 days after the last dose or new antitumor therapy starts. Tumor and health assessments occur every 12 weeks for about 2 years or until tumor recurrence or other study endpoints. If disease progresses, follow-up continues every 3 months to track survival and further treatments. The study collects data on overall survival, recurrence, tumor markers, physical status, and adverse events to understand the treatment impact and safety.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide written informed consent
- Age 18 years or older, male or female
- Pathologically confirmed upper urinary tract urothelial carcinoma (UTUC) with at least one high-risk factor: pT2 with additional high-risk features, pT3 to pT4 stage, or lymph node involvement (pN+)
- Unable to tolerate cisplatin or not receiving platinum-based adjuvant therapy
- No tumor recurrence or metastasis confirmed by imaging within 4 weeks after surgery
- HER2 immunohistochemistry results of IHC 3+ or 2+ confirmed by investigators or study center
- Expected survival time of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Normal major organ function as defined by specified blood test and coagulation criteria
You will not qualify if you...
- History of other malignancies except certain skin and bladder cancers or if disease-free for 5 years after treatment
- Previous allogeneic stem cell or organ transplantation
- Prior anti-tumor systemic therapy within 4 weeks before study or unresolved adverse events above grade 1
- Current or past congenital or acquired immunodeficiency
- Active or past autoimmune or inflammatory diseases requiring significant treatment
- Systemic immunosuppressive medication use within 2 weeks before enrollment except certain corticosteroids
- Known hypersensitivity to vedicilumab, similar antibodies, or study drug components
- Thrombosis or thromboembolic events within past 6 months
- High risk of severe bleeding or ongoing anticoagulant therapy
- Significant cardiovascular diseases including recent heart attack or uncontrolled hypertension
- Other major clinical or lab abnormalities compromising safety
- Active serious infections such as HIV, hepatitis B or C, tuberculosis, or other uncontrolled infections
- Unhealed surgical wounds or serious postoperative complications
- Pregnant or breastfeeding women, or patients unwilling to use effective contraception
- Conditions deemed inappropriate by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 weeks
Participants receive Disitamab Vedotin combined with radiotherapy as adjuvant treatment following surgery for HER2 overexpressing UTUC with high risk of recurrence.
Weekly visits for treatment and assessments
Follow-up
Duration - Approximately 2 years
Participants are monitored for disease free survival, overall survival, metastasis-free survival, local-recurrence free status, changes in ECOG performance status, tumor markers, and adverse events.
Follow-up visits every 12 weeks ± 7 days
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
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Research Team
X
Xuesong Li
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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Published Research Related To This Trial
Efficacy and Safety of Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials.
Xinan Sheng, Lin Wang, Zhisong He...
https://pubmed.ncbi.nlm.nih.gov/37988648