NCT06354231 DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC
| NCT ID | NCT06354231 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Renal Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-07-20 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2023-07-20 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 following factors: 1. Hydronephrosis; 2. Tumor diameter ≥2cm; 3. Urine cytology suggests a high-grade tumor; 4. A ureteroscopic biopsy suggests a high-grade tumor; 5. CT showed a localized invasion; 6. Multifoci diseases; 7. With multiple histological subtypes; * ECOG 0\~1; * Major organ function is normal (14 days prior to enrollment) if the following criteria are met: 1. The blood routine examination criteria should meet (no blood transfusion and no granulocyte colony stimulation agent treatment within 14 days before enrollment): HB≥90 g/L; ANC≥1.5×109 /L; PLT≥100×109 /L; 2. Non-functional organic diseases shall meet the following criteria: T-BIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5 x ULN; Serum creatinine ≤2×ULN, or endogenous creatinine clearance ≥ 30ml/min(Cockcroft-Gault formula); * Subjects (or their legal representatives) must sign an informed consent form (ICF) indicating that they understand the purpose and procedures of the study and are willing to participate in the study. * Pregnant women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the first administration of the randomized or study drug. Exclusion Criteria: * Histopathological examination revealed any small cell component of ureter or pelvis, simple adenocarcinoma, simple squamous cell carcinoma, or simple squamous CIS; * Previous treatment with other PD-1/PD-L1 inhibitors and/or HER-2 inhibitors; * Active malignancies other than the disease being studied for treatment (i.e., disease progression within the last 24 months or requiring a change in treatment), only the following special cases are allowed: i. Skin cancer that has been treated within the last 24 months and has been completely cured ii. Adequately treated lobular carcinoma in situ (LCIS) and ductus CIS iii. History of local breast cancer and is receiving antihormonal drugs or history of local prostate cancer (N0M0) and is receiving androgen blocking therapy; * History of uncontrolled cardiovascular disease, including: 1) any of the following in the past 3 months: unstable angina pectoris, myocardial infarction, ventricular fibrillation, torsion ventricular tachycardia, cardiac arrest, or known congestive New York Heart Association Class III-IV heart failure, cerebrovascular accident, or transient ischemic attack; 2) QTc interval prolongation confirmed by ECG evaluation at screening (Fridericia; QTc \> 480 ms); 3) Pulmonary embolism or other venous thromboembolism within the past 2 months; * Pregnant or lactating women; * Human immunodeficiency virus (HIV) infection is known unless the subject has been on stable antiretroviral therapy for the past 6 months or longer, has not developed an opportunistic infection in the past 6 months, and has a CD4 count \> 350 in the past 6 months. * Known history of clinically significant liver disease, including viral hepatitis \[active HBV infection, i.e., HBV DNA positive (\>1×104 copies /mL or \>2000 IU/ml) must be excluded for known hepatitis B virus (HBV) carriers; Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL), or other hepatitis, cirrhosis\]; * Have not recovered from the toxic effects of previous anticancer treatment (except for those that are not clinically significant, such as hair loss, skin discoloration, neuropathy, and hearing impairment); * Delayed wound healing, defined as skin/bedsore ulcers, chronic leg ulcers, known stomach ulcers, or non-healing of incisions; * Major surgery within 4 weeks before day 1 of Cycle 1 (TURBT is not considered a major surgery); * Other patients assessed by the investigator as unsuitable for participation in the study.
Contact & Investigator
Dingwei Ye, Doctor
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06354231 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06354231 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06354231 currently recruiting?
Yes, NCT06354231 is actively recruiting participants. Contact the research team at dwyeli@163.com for enrollment information.
Where is the NCT06354231 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06354231 clinical trial?
NCT06354231 is sponsored by Fudan University. The principal investigator is Dingwei Ye, Doctor at Fudan University. The trial plans to enroll 20 participants.