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DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC

ConditionsRenal InsufficiencyUpper Urinary Tract Urothelial CarcinomaSolitary Kidney
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

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 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

This trial does not accept healthy volunteers

Qualifiers

≥18 years old;

Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;

Refusal or ineligibility for RNU;

Hydronephrosis;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • DV

    Drug

    2.0 mg/kg, intravenously administered every 2 weeks

  • Toripalimab

    Drug

    3.0mg/kg, intravenously administered every 2 weeks

  • Laser surgery

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: DV+ToripalimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Kidney-intact disease-free survival, KI-DFS

Defined as the time to systemic relapse or death.

Time frame
Up to 12 months

Secondary outcomes

1

Time to progression, TTP

Defined as the time to systemic progression or death.

Time frame
Up to 3 years
2

Time to RNU

Defined by time from day of first treatment to RNU.

Time frame
Up to 3 years
3

Disease-specific survival time, DSS

Defined by time from day of first treatment to death due to a specific disease, reflecting the clinical benefit of a specific disease.

Time frame
Up to 3 years
4

Overall survival

Defined by time from day of first treatment to death.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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