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Tests treatment safety and results for Neoadjuvant Immunotherapy
Official title Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)
ClinicalTrials.gov ID: NCT05837806
What this study is testing
What is tislelizumab+disitamab-vedotin?
tislelizumab+disitamab-vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoadjuvant immunotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Neoadjuvant chemotherapy treatment can be used for specific UTUC patients, especially for highly staged and/or grade tumors, such as kidneys with potentially decreased renal function after RNU. Neoadjuvant therapy is a series of treatments administered preoperatively for UTUC, mainly chemotherapy, and in recent years, novel therapies of immunotherapy have emerged.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Radiographically(CT, MRI or PET-CT, etc.) and histologically confirmed diagnosis of localized HER-2 expressing upper urothelial carcinoma(...
- Male or female aged 18 years and above;
- Expected survival time greater than 12 weeks;
- An ECOG status score of 0-2;
- Agree to provide specimens of blood, urine, and tissue examination (for detection of MRD, PD-L1 expression, HER2 expression, tumor mutation load...
You likely can't join if
- Live attenuated vaccines, other than COVID-19 vaccine, received within 4 weeks prior to treatment or scheduled to be received during the study period
- Active, known or suspected autoimmune disease;
- Known history of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Female patients who are pregnant or breastfeeding
- Untreated acute or chronic active hepatitis B or C infection. Patients who are receiving antiviral therapy with monitoring of viral copy number and...
See the full eligibility criteria
- 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...
- Male or female aged 18 years and above;
- Expected survival time greater than 12 weeks;
- An ECOG status score of 0-2;
- 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.);
- 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;
- people voluntarily joined the study, signed an informed consent form, were compliant, and cooperated with the follow-up.
- Live attenuated vaccines, other than COVID-19 vaccine, received within 4 weeks prior to treatment or scheduled to be received during the study period
- Active, known or suspected autoimmune disease;
- Known history of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Female patients who are pregnant or breastfeeding
- 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...
- 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...
- Known or suspected allergy history to tislelizumab and disitamab vedotin.
- With a clear history of active tuberculosis.
- Prior PD-1/PD-L1/CTLA-4 antibody or other immunotherapy;
- Those who are participating in other clinical studies
- Men of reproductive potential or women with the potential to become pregnant who are not using reliable contraception
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.