BridgeMD
New treatment option for Upper Tract Urothelial Carcinoma
Official title Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC
ClinicalTrials.gov ID: NCT07126119
What this study is testing
What is Nab-Paclitaxel?
Nab-Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for upper tract urothelial carcinoma.
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
- This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU).
- 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
- Males or females aged no less than 18 years old;
- UTUC indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan...
- Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \>50% in the specimen from ureteroscopic...
- Suitable and planned to receive RNU.
- Expected survival time of more than 12 weeks;
You likely can't join if
- Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are...
- Confirmed bilateral upper tract urothelial carcinoma (UTUC).
- Presence of urothelial carcinoma in bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via...
- Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;
- Active, known or suspected history of autoimmune disease;
- Known history of primary immunodeficiency;
See the full eligibility criteria
- Males or females aged no less than 18 years old;
- UTUC indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0); High risk disease confirmed in...
- Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \>50% in the specimen from ureteroscopic biopsy;
- Suitable and planned to receive RNU.
- Expected survival time of more than 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2; 6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.); 7.The organ function levels...
- Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.
- Confirmed bilateral upper tract urothelial carcinoma (UTUC).
- Presence of urothelial carcinoma in bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).
- Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;
- Active, known or suspected history of autoimmune disease;
- Known history of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Pregnant or breastfeeding female patients;
- Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's...
- Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg/day of prednisone...
- Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;
- Active tuberculosis;
- Previous treatment with PD-1/PD-L1/CTLA-4 immune checkpoint inhibitors or other immunotherapies;
- Participation in another clinical study;
- Fertile men or women without effective contraception;
- Uncontrolled concurrent illness, including but not limited to: (1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Outside U.S., 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, Outside U.S., 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.