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
Qualifiers
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
Treatments tested in this trial
- RC48 Combined With Tislelizumab
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
RenJi Hospital
Lead sponsor
Tianjin Medical University Second Hospital
Collaborator
Peking University First Hospital
Collaborator
West China Hospital
Collaborator
Source ClinicalTrials.gov