Treatment before surgery for high-risk upper tract urothelial cancer
Tests drug and radiation treatment before surgery in adults with upper tract cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Disitamab Vedotin, Toripalimab, and Radiotherapy for High-risk UTUC ( LUXUS07.1 )
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-risk cancer of the upper urinary tract (renal pelvis or ureter) that can be removed by surgery. Treatment before surgery combines disitamab vedotin, toripalimab and radiotherapy.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- High-risk upper tract urothelial carcinoma that can be removed by surgery, with no distant spread. High-risk means at least one of: muscle-invasive disease, high-grade tumor, multifocal disease, tumor diameter ≥2 cm (0.8 in), hydronephrosis, or regional lymph node involvement.
- Earlier treatment
- No earlier radiotherapy to the pelvis or abdomen and no earlier systemic chemotherapy. People must be willing to have radical surgery and treatment around the operation.
- Biomarker or test result
- HER2 expression by immunohistochemistry 1+ to 3+. PD-L1 expression is not restricted.
Main reasons for not taking part
- Distant metastases or another cancer at the same time
- History of pelvic or abdominal radiotherapy, inflammatory bowel disease or systemic chemotherapy
- Pregnant or breastfeeding women, or women who could become pregnant and do not use reliable contraception
- Clinically significant heart disease
- Active infection together with a bleeding disorder
Read by machine on 9 November 2026.
Where in China
- Departmeng of Urology, Peking University First HospitaBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University First Hospital
- Trial code
- NCT07720921
- Record updated
- 28 October 2026
- Original description
This is an open-label, single-arm, single-cohort, prospective clinical study evaluating neoadjuvant antibody-drug conjugate therapy combined with immunotherapy and sequential radiotherapy followed by radical surgery in patients with high-risk upper tract urothelial carcinoma (UTUC). Eligible patients will receive neoadjuvant disitamab vedotin (RC48) plus toripalimab, followed by response-guided neoadjuvant radiotherapy and radical nephroureterectomy with bladder cuff excision. The study will assess the safety, feasibility, and preliminary antitumor activity of this multimodal neoadjuvant strategy, with pathological complete response rate as the primary endpoint.Read full original descriptionShow less
Efficacy and Safety of Neoadjuvant Disitamab Vedotin, Toripalimab, and Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study
This is an open-label, single-arm, single-cohort, prospective clinical study evaluating neoadjuvant antibody-drug conjugate therapy combined with immunotherapy and sequential radiotherapy followed by radical surgery in patients with high-risk upper tract urothelial carcinoma (UTUC). Eligible patients will receive neoadjuvant disitamab vedotin (RC48) plus toripalimab, followed by response-guided neoadjuvant radiotherapy and radical nephroureterectomy with bladder cuff excision. The study will assess the safety, feasibility, and preliminary antitumor activity of this multimodal neoadjuvant strategy, with pathological complete response rate as the primary endpoint.
Inclusion: Age ≥18 years, male or female; Imaging evaluation before treatment excludes distant organ metastasis or other concurrent malignancy and suggests resectable high-risk UTUC; Completed pathological biopsy with a clear pathological diagnosis : including puncture biopsy, ureteroscopy and urine cytology, at least one of which is clearly diagnosed as uroepithelial carcinoma, which may include no more than 50% or more proportion of squamous, adenoid, sarcomatoid differentiation and other special differentiation types; High-risk features, including muscle-invasive disease, high-grade tumor, multifocal disease, tumor diameter ≥2 cm, hydronephrosis, or regional lymph node involvement; HER2 expression by immunohistochemistry 1+ to 3+; PD-L1 expression not restricted; Have the willingness to undergo radical surgical treatment and perioperative adjuvant treatment, have good compliance, and be able to co-operate with the treatment and follow-up plan specified by the clinician; Postoperative life expectancy of at least 6 months; ECOG score ≤ 2.
Exclusion: Distant metastases or other malignant neoplastic diseases combined with other malignant neoplasms in the same period had been detected at the time of surgery, or the present was a progression after palliative resection of previous epithelial carcinoma of the urothelium; History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; The presence of active infections in those with pre-existing or coexisting haemorrhagic disorders; clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) class ≥II congestive heart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vascular disease); Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception; Psychological, familial, and social factors leading to lack of informed consent.