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Can a triple threat of drug, immunotherapy, and radiation wipe out High-Risk urinary tract cancer before surgery?
NCT ID NCT07720921
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of an antibody-drug conjugate (disitamab vedotin), an immunotherapy (toripalimab), and targeted radiation can improve outcomes for people with high-risk upper tract urothelial carcinoma. Participants receive the drug and immunotherapy, followed by a short course of radiation, and then undergo surgery to remove the affected kidney and ureter. The main goal is to see if this approach can eliminate all signs of cancer in the surgical specimen.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of disitamab vedotin (an antibody-drug conjugate), toripalimab (an immunotherapy), and radiotherapy
- What this could lead to
- If successful, this approach could offer a more effective way to shrink or eliminate tumors before surgery, potentially improving outcomes for people with high-risk upper tract urothelial carcinoma.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply broadly. The combination of drugs and radiation may cause significant side effects, and it is not yet known if it will improve long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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; * Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception; * 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); * Psychological, familial, and social factors leading to lack of informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Departmeng of Urology, Peking University First Hospita
Beijing, Beijing Municipality, China
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Other studies related to the condition(s) this trial covers.
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- Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
- MRI 'Fingerprint' may reveal which head and neck tumors vanish with Pre-Surgery therapy
- Can a Two-Drug punch shrink esophageal tumors before surgery?
- Can a Dual-Drug combo shrink lung tumors before surgery?
- Can a Two-Drug punch shrink oral tumors before surgery?