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Upper Urinary Tract Urothelial CarcinomaPhase 2NCT05912816

Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients

A Phase 2 study testing RC48 Combined With Tislelizumab in people with Upper Urinary Tract Urothelial Carcinoma and Kidney Preservation, run by RenJi Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
RC48 Combined With Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
10 Jun 2023to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
  • 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)
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  • 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 therapy should keep anticoagulants within therapeutic limits);
  • 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 contraception combined with spermicide) and continue using contraception for 12 months after the end of treatment;
  • The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Who cannot join

  • 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;
  • Positive HIV test result;
  • People with active hepatitis B or C
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  • 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 HBV DNA;
  • 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 therapy (e.g., thyroxine, pancreatic hormone, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency);
  • 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 diabetes, cardiovascular disease (heart failure of Grade Ⅲ or Ⅳ as defined by the New York Heart Association scale, heart block above grade Ⅱ, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) Or pulmonary disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm);
  • 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 cervix or carcinoma in situ of the breast; Remarks: Patients with localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and PSA≤10ng/mL at the time of prostate cancer diagnosis (as measured) who had received radical therapy and had no biochemical recurrence of prostate specific antigen (PSA) were eligible to participate in this study);
  • 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 interpretation of the study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

jiwei huang contact

8613651682825

jiweihuang@outlook.com

China1 site, 1 recruiting

  • Ethics Committee of Shanghai Renji Hospital

    Shanghai, Shanghai Municipality

    Qi Lu, +86021-68383364, rjllb3364@163.com

    Recruiting

Other trials in China

About this study

Official title: Perioperative Disitamab Vedotin and Tislelizumab Followed by Nephron-Sparing Surgery in High-Risk Upper Tract Urothelial Carcinoma: A Phase 2 Trial (DISTINCT-I)

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).

Being tested
RC48 Combined With Tislelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC48 Combined With TislelizumabDrug

    In 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.

Study groups in NCT05912816
Study groupRoleWhat they receive
RC48 Combined With TislelizumabExperimentalIn 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.
Receives: Drug: RC48 Combined With Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 1 year

Secondary outcomes (6)

  1. clinical complete response

    The rate of CCR is defined by negative ureteroscope, urine cytology, and negative imaging

    Measured: 3 month before surgery

  2. clinical complete response

    The rate of CCR is defined by negative ureteroscope, urine cytology, and negative imaging

    Measured: 4 month after surgery

  3. disease-free survival

    the time from enrollment to any disease recurrence (excluding isolated bladder recurrence) or death from any cause

    Measured: up to 2 year

  4. the proportion of adverse events

    adverse events graded according to CTCAE version 5.0

    Measured: up to 2 year

  5. the proportion of RUN

    The proportion of patients undergoing radical surgery for UTUC (upper tract urothelial carcinoma) after enrollment.

    Measured: up to 2 year

  6. renal function preservation

    the change in eGFR from baseline to 1 year

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start10 Jun 2023
  3. Primary completion3 Nov 2025
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
In 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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05912816
Sponsor's protocol ID
DISTINCT-I
Status last verified
Dec 2025
First submitted
11 Jun 2023
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC48 Combined With Tislelizumab in people with Upper Urinary Tract Urothelial Carcinoma and Kidney Preservation, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jiwei huang (8613651682825, jiweihuang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

kidney-intact event-free survival (KI-EFS) (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05912816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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