DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC
Recruiting
Phase 2
Interventional Study
Renal Insufficiency
Upper Urinary Tract Urothelial Carcinoma
Solitary Kidney
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* ≥18 years old;
* Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;
* Refusal or ineligibility for RNU;
* Preoperative risk stratification was defined as high-risk UTUC, defined as patients with any of the foll…
Contacts