Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRenJi Hospital
About this trial
This is a prospective, open, multiple-center clinical study of renal preservation therapy in high-risk upper urinary tract urothelial carcinoma patients . The study was conducted in accordance with the Good Practice for Quality Control of Clinical Trials for Pharmaceutical Products (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (2.0 mg/kg intravenously every 3 weeks) combined with Tislelizumab (200mg intravenously every 3 weeks).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ECOG 0~2;
HER-2 IHC 0-3+;
Subjects underwent cystoscopic/ureteroscopic biopsy, exfoliation cytology, and CT/MRI diagnosis;
Patients were judged to be high-risk urothelial carcinoma of the upper urinary tract (meeting any of the following risk factors: hydronephrosis, tumor diameter ≥2cm, high-grade, multiple tumors in cytology, previous history of radical cystectomy for high-grade bladder cancer, biopsy pathology with other tissue components);
Disqualifiers
Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy, including adjuvant therapy stage;
Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
Had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks prior to the study treatment, or had not recovered from the previous toxicity (except for 2 degrees of hair loss and 1 degree of neurotoxicity);
Pregnant or lactating women;
Trial design
Design model
Single group
Treatments tested in this trial
RC48 Combined With Tislelizumab
DrugIn this trial, RC48 was scheduled to be administered at a dose of 2.0 mg/kg every 3 weeks, with the first dose on day 1 of the first cycle. Tislelizumab was administered at a dose of 200 mg every 3 weeks, with the first dose on day 1 of the first 21-day cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: RC48 Combined With TislelizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
kidney-intact event-free survival (KI-EFS)
the time from enrollment to any event, including high-risk UTUC local recurrence(tumor size ≥2 cm, local invasion on CT or MRI, hydronephrosis, or multifocality), distant metastasis, death from any cause, or conversion to RNU
Time frame
up to 1 yearSecondary outcomes
1
clinical complete response
The rate of CCR is defined by negative ureteroscope, urine cytology, and negative imaging
Time frame
3 month before surgery2
clinical complete response
The rate of CCR is defined by negative ureteroscope, urine cytology, and negative imaging
Time frame
4 month after surgery3
disease-free survival
the time from enrollment to any disease recurrence (excluding isolated bladder recurrence) or death from any cause
Time frame
up to 2 year4
the proportion of adverse events
adverse events graded according to CTCAE version 5.0
Time frame
up to 2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
RenJi Hospital
Lead sponsor
Tianjin Medical University Second Hospital
Collaborator
Peking University First Hospital
Collaborator
West China Hospital
Collaborator
Source ClinicalTrials.gov