New combo aims to stop rare Cancer's return after surgery
NCT ID NCT06210490
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether a targeted drug called disitamab vedotin, given together with radiation therapy, can prevent cancer recurrence in people with HER2-positive upper tract urothelial cancer who are at high risk after surgery. About 60 participants will either receive the combination treatment or be closely watched. The study will track how long they remain cancer-free and monitor side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Disitamab vedotin (a targeted antibody-drug conjugate) and radiotherapy
- What this could lead to
- If successful, this combination could offer a new option to reduce the chance of cancer returning after surgery for patients with HER2-positive upper tract urothelial cancer.
- What could go wrong
- This is a small, early-phase study with only 60 participants, so results may not apply broadly. The drug can cause side effects like nerve damage or low blood counts, and it is not yet proven to improve survival.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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May 2028
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: 1. Voluntary enrollment and signing of written informed consent; 2. Age ≥ 18 years, male or female; 3. 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+; 4. Cisplatin intolerance or not receiving platinum-based drugs for adjuvant therapy; 5. No recurrent metastasis confirmed by imaging ≥4 weeks postoperatively; 6. HER2 immunohistochemistry (IHC) results of IHC 3+ or 2+, subject's previous test results (confirmed by the investigator), and study center results are acceptable; 7. Expected survival time ≥ 6 months; 8. Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score of 0 to 1; 9. Normal major organ function, i.e., fulfillment of the following criteria: * Routine blood tests (no blood transfusion and no G-CSF use within 14 days prior to screening): a) Hemoglobin ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; c) Leukocyte count ≥ 3.0 × 10\^9 /L; d) Platelet count ≥ 80 × 10\^9/L ②Blood biochemistry (no albumin use within 14 days prior to screening): a) Albumin ≥ 28 g/L; b) Total bilirubin ≤ 2 x upper limit of normal (ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x ULN in the absence of liver metastases, and ALT, AST, and ALP ≤ 5 x ULN in the presence of liver metastases; d) Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 50 mL/min calculated by the Cockcroft-Gault formula ③Coagulation: a) International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN; b) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Exclusion Criteria: 1. A history of malignancy other than uroepithelial carcinoma, except in the following two cases: a) The patient has received potentially curative therapy and has had no evidence of the disease for 5 years; b) Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the uterine cervix, and other carcinomas in situ for which resection was successfully received; 2. Prior allogeneic stem cell or parenchymal organ transplantation; 3. Patients who have received other prior anti-tumor systemic therapy (including herbal medicine with anti-tumor indications) less than 4 weeks after completion of therapy and prior to dosing in this study, or who have not recovered from adverse events caused by prior therapy to ≤ CTCAE grade 1 (with the exception of alopecia and hyperpigmentation); 4. Prior or current congenital or acquired immunodeficiency disease; 5. Active or previously documented autoimmune or inflammatory diseases (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, pituitary gland inflammation, hyper- or hypothyroidism, and asthma requiring bronchodilator therapy), with vitiligo, or asthma that has resolved completely in childhood and does not require any intervention in adulthood; 6. Treatment with systemic immunosuppressive medication within 2 weeks prior to enrollment or anticipated need for systemic immunosuppressive medication during the study period, with the exception of the following: a) Intranasal, inhaled, topical, or locally injected (e.g., intra-articular injection) corticosteroids; b) Systemic corticosteroids in doses not exceeding 10 mg/day of prednisone or other equivalent effect; c) Prophylactic corticosteroids for hypersensitivity reactions; 7. Patients with a known or suspected history of hypersensitivity to vedicilumab and similar drugs, or a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or to excipients of the study drug; 8. Prior thrombosis or thromboembolic event within the previous 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc; 9. Patients assessed by a physician to be at risk for severe bleeding, including but not limited to severe bleeding (\> 30 ml within 3 months), hemoptysis (\> 5 ml within 4 weeks), with gastroscopy/assessment in the event of any of the above, whichever is based on the microscopic assessment or active bleeding or coagulation abnormality, with a propensity to hemorrhage or undergoing thrombolytic, anticoagulant, or antiplatelet therapy; 10. clinically significant cardiovascular disease including, but not limited to, acute myocardial infarction, severe/unstable angina or coronary artery bypass grafting within the previous 6 months, congestive heart failure (New York Heart Association NYHA classification \> grade 2), arrhythmias that are poorly controlled or require pacemaker therapy, hypertension that is uncontrolled by medications (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg); 11. Other significant clinical and laboratory abnormalities that, in the opinion of the investigator, compromise the safety evaluation, e.g., uncontrolled diabetes mellitus, chronic kidney disease, grade II or greater peripheral neuropathy (CTCAE V5.0), abnormal thyroid function; 12. Serious infections that are active or poorly controlled clinically active infections, including: a) Positive for the AIDS virus (HIV) (HIV1/2 antibodies); b) Active Hepatitis B (HBsAg positive or HBV DNA \> 2000 IU/ml and abnormal liver function); c) Active hepatitis C (HCV antibody positive or HCV RNA ≥103 copies/ml and abnormal liver function); d) Active tuberculosis; e) Other uncontrolled active infection (CTCAE V5.0 \> grade 2); 13. Not yet recovered from surgery, e.g. presence of unhealed incisions or serious postoperative complications; 14. Women who are pregnant or breastfeeding, and female or male patients of childbearing potential who are unwilling or unable to use effective contraception; 15. other conditions that the investigator deems inappropriate for inclusion.
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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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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, 100034, China
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Other studies related to the condition(s) this trial covers.
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- Major european study tests if Kidney-Saving surgery is safe for rare cancer