RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients (NCT07100184) | Clinical Trial Compass
Not Yet RecruitingPhase 2
RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients
30 participantsStarted 2025-09-01
Plain-language summary
This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT). The study plans to enroll 30 patients with high or very high risk HER2-expression NMIBC without visible lesions after TURBT. The study includes a screening period, a treatment period, and a survival follow-up period. This is a single-center study conducted at the Peking University First Hospital, and the PI is Prof. CuiJian Zhang.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. voluntarily agree to participate in the study and sign an informed consent form;
. male or female, age ≥18 years;
. disease fulfillment:
. the patient's disease status was determined by at least two associate or chief physicians to be free of visible lesions to the naked eye after transurethral bladder tumor electrodessication;
. A definitive postoperative pathologic diagnosis of non-muscle invasive bladder cancer with \>50% of its major tissue component being uroepithelial carcinoma (migratory cell carcinoma);
. Completion of TURBT within 4 weeks prior to study administration and completion of immediate chemotherapy infusion (chemotherapy agent is mitomycin);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Absence of focal lymph node metastasis as well as distant metastasis confirmed by imaging (including but not limited to thoracoabdominopelvic CT/MR or PET/CT) within 6 weeks prior to enrollment, i.e., N0M0;
. Subject's NMIBC risk grouping is consistent with a high or very high risk group:
. have received any other antineoplastic therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., within 4 weeks prior to study dosing, excluding 1 instillation of chemotherapy completed immediately after TURBT;
. has not recovered to CECAT 5.0 grade 0-1 from an adverse event caused by a previously applied antineoplastic agent within 2 weeks prior to initiation of study drug administration;
. who have had major surgery within 4 weeks prior to the start of study dosing or are scheduled to have major surgery during the study period;
. Serum virology: a) Positive HBsAg with a positive HBVDNA copy number. b) Positive HCVAb with a positive HBVDNA copy number. c) Positive HBsAg with a positive HBVDNA copy number. d) Positive HBsAg with a positive HBV DNA copy number;
. have received a live vaccine within 4 weeks prior to the start of study drug administration or plan to receive any vaccine during the study period;
. heart failure classified by the New York Heart Association (NYHA) as Grade 3 or higher;
. a serious arterial/venous thrombotic event or cardiovascular accident such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., except for lacunar cerebral infarcts, which are asymptomatic and do not require clinical intervention, within the 6 months prior to study dosing;