Status and phase
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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.
Enrollment
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Volunteers
Inclusion criteria
Voluntary enrollment and signing of written informed consent;
Age ≥ 18 years, male or female;
Pathologically confirmed UTUC with at least any one of the following conditions: ① pT2 (need to be combined with at least simultaneous G3/high-grade tumor multiple, multifocal positive margins and one of the high-risk recurrence factors); ② pT3 to pT4; ③ pN+;
Cisplatin intolerance or not receiving platinum-based drugs for adjuvant therapy;
No recurrent metastasis confirmed by imaging ≥4 weeks postoperatively;
HER2 immunohistochemistry (IHC) results of IHC 3+ or 2+, subject's previous test results (confirmed by the investigator), and study center results are acceptable;
Expected survival time ≥ 6 months;
Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score of 0 to 1;
Normal major organ function, i.e., fulfillment of the following criteria:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Central trial contact
Xuesong Li
Data sourced from clinicaltrials.gov
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