Renal InsufficiencyPhase 2NCT06354231
DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC
A Phase 2 study testing DV, Toripalimab and Laser surgery in people with Renal Insufficiency and Upper Urinary Tract Urothelial Carcinoma, run by Fudan University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Upper Urinary Tract Urothelial Carcinoma, Solitary Kidney
- What is being tested?
- DV, Toripalimab and Laser surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old;
- Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;
- Refusal or ineligibility for RNU;
- Preoperative risk stratification was defined as high-risk UTUC, defined as patients with any of the following factors:
- Hydronephrosis;
- Tumor diameter ≥2cm;
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- Urine cytology suggests a high-grade tumor;
- A ureteroscopic biopsy suggests a high-grade tumor;
- CT showed a localized invasion;
- Multifoci diseases;
- With multiple histological subtypes;
- ECOG 0~1;
- Major organ function is normal (14 days prior to enrollment) if the following criteria are met:
- The blood routine examination criteria should meet (no blood transfusion and no granulocyte colony stimulation agent treatment within 14 days before enrollment): HB≥90 g/L; ANC≥1.5×109 /L; PLT≥100×109 /L;
- Non-functional organic diseases shall meet the following criteria: T-BIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5 x ULN; Serum creatinine ≤2×ULN, or endogenous creatinine clearance ≥ 30ml/min(Cockcroft-Gault formula);
- Subjects (or their legal representatives) must sign an informed consent form (ICF) indicating that they understand the purpose and procedures of the study and are willing to participate in the study.
- Pregnant women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the first administration of the randomized or study drug.
Who cannot join
- 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;
- Pregnant or lactating women;
- Human immunodeficiency virus (HIV) infection is known unless the subject has been on stable antiretroviral therapy for the past 6 months or longer, has not developed an opportunistic infection in the past 6 months, and has a CD4 count > 350 in the past 6 months.
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- Known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA positive (>1×104 copies /mL or >2000 IU/ml) must be excluded for known hepatitis B virus (HBV) carriers; Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis];
- Have not recovered from the toxic effects of previous anticancer treatment (except for those that are not clinically significant, such as hair loss, skin discoloration, neuropathy, and hearing impairment);
- Delayed wound healing, defined as skin/bedsore ulcers, chronic leg ulcers, known stomach ulcers, or non-healing of incisions;
- Major surgery within 4 weeks before day 1 of Cycle 1 (TURBT is not considered a major surgery);
- Other patients assessed by the investigator as unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
dingwei ye, 64175590-82800
About this study
Official title: A Prospective, Open-label, Single-arm, Clinical Study of Disitamab Vedotin Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple Upper Urinary Tract Urothelial Carcinoma
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.
- Being tested
- DV, Toripalimab, Laser surgery
- Medical subject headings
- Renal Insufficiency, Solitary Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVDrug
Also called RC48
2.0 mg/kg, intravenously administered every 2 weeks
ToripalimabDrug
Also called JS001
3.0mg/kg, intravenously administered every 2 weeks
Laser surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| DV+Toripalimab | Experimental | DV, 2.0 mg/kg, intravenously administered every 2 weeks; toripalimab, 3.0mg/kg, intravenously administered every 2 weeks; Receives: Drug: DV; Drug: Toripalimab; Procedure: Laser surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney-intact disease-free survival, KI-DFS
Defined as the time to systemic relapse or death.
Measured: Up to 12 months
Secondary outcomes (5)
Time to progression, TTP
Defined as the time to systemic progression or death.
Measured: Up to 3 years
Time to RNU
Defined by time from day of first treatment to RNU.
Measured: Up to 3 years
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.
Measured: Up to 3 years
Overall survival
Defined by time from day of first treatment to death.
Measured: Up to 3 years
3m complete remission
CR is defined by CT urography
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start20 Jul 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
- Investigators
- Dingwei Ye, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354231
- Sponsor's protocol ID
- RC48-C012
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-arm, Clinical Study of Disitamab Vedotin Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple Upper Urinary Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06354231
- Acronym / sponsor ID
- RC48-C012
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DV+Toripalimab | Experimental | Drug: DV, Drug: Toripalimab, Procedure: Laser surgeryDV, 2.0 mg/kg, intravenously administered every 2 weeks; toripalimab, 3.0mg/kg, intravenously administered every 2 weeks; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- ≥18 years old;
- Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;
- Refusal or ineligibility for RNU;
- Preoperative risk stratification was defined as high-risk UTUC, defined as patients with any of the following factors:
- ECOG 0~1;
Key exclusion criteria (11 listed)
- 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;
- Pregnant or lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DVAlso: RC482.0 mg/kg, intravenously administered every 2 weeks | Drug | DV+Toripalimab |
| ToripalimabAlso: JS0013.0mg/kg, intravenously administered every 2 weeks | Drug | DV+Toripalimab |
| Laser surgerySubjects 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. | Procedure or surgery | DV+Toripalimab |
Primary outcome
Kidney-intact disease-free survival, KI-DFS
Time frame: Up to 12 months
Defined as the time to systemic relapse or death.
5 secondary outcomes
Time to progression, TTP
Time frame: Up to 3 years
Time to RNU
Time frame: Up to 3 years
Disease-specific survival time, DSS
Time frame: Up to 3 years
Overall survival
Time frame: Up to 3 years
3m complete remission
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dingwei Ye, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DV, Toripalimab and Laser surgery in people with Renal Insufficiency and Upper Urinary Tract Urothelial Carcinoma, run by Fudan University 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 17 inclusion and 11 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 11 Apr 2024. 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 Dingwei Ye, Doctor (64175590-82800, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney-intact disease-free survival, KI-DFS (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2024.