Actively Recruiting
DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC
Led by Fudan University · Updated on 2024-04-11
20
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment.
CONDITIONS
Official Title
DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Histologically confirmed solitary kidney, renal insufficiency, or bilateral upper urinary tract urothelial carcinoma
- Refusal or ineligibility for radical nephroureterectomy (RNU)
- High-risk UTUC defined by any of the following: hydronephrosis, tumor diameter 2 cm or larger, urine cytology indicating high-grade tumor, ureteroscopic biopsy showing high-grade tumor, CT evidence of localized invasion, multifocal disease, or multiple histological subtypes
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Normal major organ function within 14 days prior to enrollment, including specific blood counts and liver and kidney function criteria
- Signed informed consent form indicating understanding and willingness to participate
- Negative pregnancy test within 7 days before first treatment (for women)
You will not qualify if you...
- Histopathology showing small cell component of ureter or pelvis, simple adenocarcinoma, simple squamous cell carcinoma, or simple squamous carcinoma in situ
- Previous treatment with other PD-1/PD-L1 inhibitors or HER-2 inhibitors
- Active malignancies other than the study disease within last 24 months, except certain treated cancers
- History of uncontrolled cardiovascular disease or recent serious heart or vascular events
- Prolonged QTc interval over 480 ms on ECG at screening
- Pulmonary embolism or venous thromboembolism within past 2 months
- Pregnant or breastfeeding women
- Known HIV infection unless stable on antiretroviral therapy with no recent infections and adequate CD4 count
- Significant liver disease including active hepatitis B or C infection
- Not fully recovered from prior anticancer treatment toxicities except minor ones
- Delayed wound healing conditions such as chronic ulcers
- Major surgery within 4 weeks before starting treatment (except TURBT)
- Other conditions judged by investigators as unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
D
Dingwei Ye, Doctor
CONTACT
H
Hailiang Zhang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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