Actively Recruiting
A Clinical Study of Disitamab Vedotin Combined With Toripalimab for Kidney Preservation in Patients With Solitary Kidney, Renal Insufficiency, or Bilateral Upper Urinary Tract Urothelial Carcinoma
Led by Fudan University · Updated on 2024-04-11
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the effectiveness and safety of combining Disitamab Vedotin (DV) and Toripalimab in patients with renal insufficiency, solitary kidney, or bilateral multiple upper urinary tract urothelial carcinoma (UTUC). The study will enroll about 20 participants who have refused or are ineligible for radical nephroureterectomy (RNU), focusing on preserving kidney function while treating cancer. It is a phase 2 clinical trial led by Fudan University. Participants will receive DV at a dose of 2.0 mg/kg and Toripalimab at 3.0 mg/kg, both given intravenously every two weeks. The treatment consists of 6 cycles of these drugs followed by laser surgery to remove tumors from the ureter or renal pelvis. After surgery, participants will continue with 12 more cycles of DV and one year of Toripalimab as consolidation therapy to support ongoing disease control. Throughout the study, participants will undergo cystoscopy, ureteroscopy, laboratory tests, and imaging scans to monitor treatment effects and safety. The primary outcome is kidney-intact disease-free survival measured up to 12 months. Secondary outcomes include time to disease progression, time to radical nephroureterectomy, disease-specific survival, overall survival, and complete remission rates up to three years. The total study period extends through treatment and follow-up, with careful monitoring of kidney preservation and cancer control.
CONDITIONS
Brief 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 based on at least one of the following: hydronephrosis, tumor diameter 2 cm or larger, urine cytology indicating high-grade tumor, ureteroscopic biopsy indicating high-grade tumor, CT showing localized invasion, multifocal disease, or multiple histological subtypes
- ECOG performance status 0 to 1
- Normal major organ function within 14 days before enrollment including blood counts (Hb ≥ 90 g/L, ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L)
- Liver and kidney function within specified limits (T-BIL ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN; serum creatinine ≤ 2 x ULN or creatinine clearance ≥ 30 ml/min)
- Signed informed consent
- Negative pregnancy test within 7 days before first study drug administration for women of childbearing potential
You will not qualify if you...
- Histopathology showing small cell component, simple adenocarcinoma, simple squamous cell carcinoma, or squamous carcinoma in situ of ureter or pelvis
- Prior treatment with PD-1/PD-L1 or HER-2 inhibitors
- Active malignancies other than the study disease, except certain treated skin cancers, lobular carcinoma in situ, ductus carcinoma in situ, or local breast/prostate cancers under stable treatment
- Uncontrolled cardiovascular disease within past 3 months including unstable angina, myocardial infarction, ventricular arrhythmias, congestive heart failure (NYHA III-IV), stroke, or transient ischemic attack
- Prolonged QTc interval > 480 ms on ECG at screening
- Pulmonary embolism or venous thromboembolism within past 2 months
- Pregnant or lactating women
- Known HIV infection unless stable on antiretroviral therapy for at least 6 months with good immune status
- Significant liver disease including active hepatitis B or C infection or cirrhosis
- Not recovered from prior anticancer treatment toxicities except minor effects like hair loss or neuropathy
- Delayed wound healing conditions such as chronic ulcers or non-healing incisions
- Major surgery within 4 weeks before starting study treatment (except TURBT)
- Other conditions judged by investigator as unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 year and 6 months
Participants receive 6 cycles of Disitamab Vedotin and Toripalimab administered intravenously every 2 weeks, followed by laser surgery to remove tumors, then continue with 12 additional cycles of Disitamab Vedotin and 1 year of Toripalimab consolidation therapy.
Biweekly visits for drug administration during initial and subsequent cycles plus visits for laser surgery and recovery
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
D
Dingwei Ye, Doctor
H
Hailiang Zhang, Doctor
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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