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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Radiotherapy dose: 45-50 Gy/25f/5w to lymph node drainage area; 62.5 Gy/25f/5w to metastatic or suspected metastatic lymph nodes.
Standard of Care
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGDisease Free Survival (DFS)
Time frame: Follow-up every 12 weeks ± 7 days, for approximately 2 years
Overall Survival (OS)
Time frame: Follow-up every 12 weeks ± 7 days, for approximately 2 years
Metastasis-Free Survival (MFS)
Time frame: Follow-up every 12 weeks ± 7 days, for approximately 2 years
Local-Recurrence Free (LRF)
Time frame: Follow-up every 12 weeks ± 7 days, for approximately 2 years
Over-time Changes in ECOG PS scores
Ecog PS score Eastern Cooperative Oncology Group (ECOG) Performance Status: the minimum value is 0 and maximum value is 4. Higher scores mean a worse outcome.
Time frame: Follow-up every 12 weeks ± 7 days, for approximately 2 years
Over-time Changes in tumor markers
Time frame: Follow-up every 12 weeks ± 7 days, for approximately 2 years
Adverse events and serious adverse events
Time frame: Follow-up every 12 weeks ± 7 days, for approximately 2 years
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