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New treatment option for Upper Urinary Tract Urothelial Carcinoma
Official title Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients
ClinicalTrials.gov ID: NCT05912816
What this study is testing
What is RC48 Combined With Tislelizumab?
RC48 Combined With Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for upper urinary tract urothelial carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- ECOG 0\~2;
- HER-2 IHC 0-3+;
- people 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...
- High-risk UTUC(excluding low-risk UTUC),including renal pelvic tumors (cT1-T3, N0) or ureteral tumors (cT1-T3, N0-N1) M0;
You likely can't join if
- 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...
- Pregnant or lactating women;
- Positive HIV test result;
- People with active hepatitis B or C
See the full eligibility criteria
- ECOG 0\~2;
- HER-2 IHC 0-3+;
- people 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...
- High-risk UTUC(excluding low-risk UTUC),including renal pelvic tumors (cT1-T3, N0) or ureteral tumors (cT1-T3, N0-N1) M0;
- Patients with indications of absolute or relative renal protection (only kidney, renal insufficiency: eGFR \< 60 ml/min)
- Have the desire to protect the kidney;
- There is no indication of absolute or relative kidney preservation, but patients have a strong desire to preserve kidney.
- Has and agrees to provide cystoscopic/ureteroscopic biopsy tissue specimens and to reserve pre-treatment blood,
- Urine and biopsied biological samples;
- Predicted survival ≥3 months;
- Major organ function is normal (14 days prior to enrollment)
- International Normalized ratio (INR), activated partial thromboplastin time (aPTT) : ≤1.5× ULN (This criterion only applies to patients who are not receiving anticoagulant therapy; Patients receiving anticoagulant...
- Did not receive systemic corticosteroid medication within 4 weeks prior to treatment;
- Fertile men or women who are at risk of becoming pregnant must use a highly effective contraceptive method during the trial (such as oral contraceptives, intrauterine devices, controlled sexual desire or barrier...
- The people voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
- 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...
- Pregnant or lactating women;
- Positive HIV test result;
- People with active hepatitis B or C
- HBsAg or HBcAb positive patients also detected HBV DNA copy number positive (quantitative detection limit is 500IU/ml, or reach the positive value of the study center); Screening studies of such patients must test for...
- Patients who tested positive for HCV antibodies were enrolled in this study only if the PCR results of HCV RNA were negative.
- A clear history of active tuberculosis;
- Have active autoimmune diseases that have required systemic treatment within the past 2 years (e.g., with disease-regulating drugs, corticosteroids, or immunosuppressive drugs) that allow for relevant replacement...
- Other serious, uncontrolled concomitant diseases that may affect protocol adherence or interfere with interpretation of results, These include active opportunistic or progressive (severe) infections, uncontrolled...
- Received live vaccine within 4 weeks prior to the start of treatment;
- Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Major surgical procedures (excluding diagnostic surgery) within 4 weeks prior to the start of treatment; Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders;
- A large amount of pleural effusion or ascites accompanied by clinical symptoms or requiring symptomatic treatment;
- Have had other unhealed malignancies in the past 5 years, excluding those that are apparently cured or curable, such as basal or squamous cell skin cancer, localized low-risk prostate cancer, carcinoma in situ of the...
- Bladder cancer (MIBC);
- Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, according to the investigator, may increase the risks associated with study participation or may interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.