Using Tislelizumab and Disitamab-vedotin for Neoadjuvant Therapy in High-risk Upper Tract Urothelial Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of combining tislelizumab, an immunotherapy drug, with disitamab-vedotin as a neoadjuvant treatment for patients with high-risk upper tract urothelial carcinoma (UTUC). The study aims to provide an alternative to traditional chemotherapy, particularly for patients who may not tolerate cisplatin due to renal function concerns. Participants will undergo a series of preoperative treatments to assess the feasibility and safety of this novel immunotherapy regimen. The trial will include various assessments, including blood and tissue examinations to evaluate treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Radiographically(CT, MRI or PET-CT, etc.) and histologically confirmed diagnosis of localized HER-2 expressing upper urothelial carcinoma( (cT1-4N0-2M0, HER-2 immunohistochemistry (IHC) ≥ 1+); high risk disease (according to EAU Guidelines for UTUC); planning to receive radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA).
2. Male or female aged 18 years and above;
3. Expected survival time greater than 12 weeks;
4. An ECOG status score of 0-2;
5. Agree to provide specimens of blood, urine, and tissue examination (for detection of MRD, PD-L1 expression, HER2 expression, tumor mutation load, immunohistochemistry, DNA and RNA detection, etc.);
6. The level of organ function must meet the following requirements:

   * hematological indicators: absolute neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 80 × 10\^9/L, hemoglobin ≥ 6.0 g/dL (can be maintained by symptomatic treatment)
   * hepatic function: total bilirubin ≤ 1.5 times the upper limit of normal, and glutathione and glutamic oxalacetic transaminase ≤ 2.5 times the upper limit of normal;
   * renal function: GFR ≥ 15 ml/min;
   * Subjects voluntarily joined the study, signed an informed consent form, were compliant, and cooperated with the follow-up.

Exclusion Criteria:

1. Live attenuated vaccines, other than COVID-19 vaccine, received within 4 weeks prior to treatment or scheduled to be received during the study period
2. Active, known or suspected autoimmune disease;
3. Known history of primary immunodeficiency;
4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
5. Female patients who are pregnant or breastfeeding
6. Untreated acute or chronic active hepatitis B or C infection. Patients who are receiving antiviral therapy with monitoring of viral copy number and are eligible for enrollment as determined by the physician on an individual patient basis;
7. Previous use of immunosuppressive drugs, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day prednisolone or equivalent pharmacologic physiologic doses of other corticosteroids), within 4 weeks prior to initiation of therapy
8. Known or suspected allergy history to tislelizumab and disitamab vedotin.
9. With a clear history of active tuberculosis.
10. Prior PD-1/PD-L1/CTLA-4 antibody or other immunotherapy;
11. Those who are participating in other clinical studies
12. Men of reproductive potential or women with the potential to become pregnant who are not using reliable contraception
13. Uncontrolled co-morbidities, including but not limited to

    * HIV-infected individuals (HIV-positive);
    * Severe infections that are active or poorly controlled clinically (including patients in the period of neocoronavirus infection)
    * Evidence of the presence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension \[i.e., defined as greater than or equal to CTCAE grade 2 hypertension despite medication\]).

Where it's running

• The Second Hospital of Tianjin Medical University
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Hailong Hu, MD,PhD — Tianjin Medical University Second Hospital
• Study coordinator: Hailong Hu, MD,PhD
• Email: hhllove2004@163.com
• Phone: +86 13662096232

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting at 2 sites Phase 2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality and 1 other locations · NCT06560528

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

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• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

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• Tislelizumab plus Anlotinib after chemoradiotherapy in limited-stage SCLC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.