Non-Muscle Invasive Bladder CancerPhase 2NCT05957757
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
A Phase 2 study testing RC48 and Tislelizumab in people with Non-Muscle Invasive Bladder Cancer and HER2, run by RenJi Hospital at 1 site in China.
Trial summary
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer, HER2
- What is being tested?
- RC48 and 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
- 5 Aug 2023to 8 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Histologically confirmed recurrent, non-muscle invasive bladder cancer;
- Histopathology: Patients with any variant urothelial cell carcinoma (UCC) (i.e., squamous and/or glandular epithelial differentiation UCC, UCC with micropapillary changes, nest variant UCC, plasmacytoid UCC, neuroendocrine UCC, and sarcomatoid UCC) were enrolled. The presence of any lymphatic infiltration (LVI) is considered evidence of high risk.
- Papillary carcinoma must be a high-risk disease defined as a high grade Ta/T1 lesion. In addition, subjects must have all visible tumors completely removed prior to initial administration of the study drug, as documented at baseline cystoscopy. Cytological results for high-grade urothelial carcinoma must be negative prior to initial administration of the investigational drug.
- CIS does not require complete excision, but must be completely excised with coexisting papillary carcinoma prior to enrollment and documented at baseline cystoscopy. Negative urine cytology for malignant cells is not required.
- When BCG recurred after treatment, the presence of HER2 expression was detected by IHC in the pathology department of our hospital
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- BCG treatment failure included no response to BCG treatment and relapse after inadequate BCG treatment
- Subjects without response after adequate BCG treatment must meet at least one of the following criteria: 1) Persistent or recurrent simple CIS with or without recurrent Ta/T1 (non-invasive papillary carcinoma/tumor invasion of subepithelial connective tissue) disease within 12 months after completion of adequate BCG treatment; 2) Recurrent high-grade Ta/T1 disease occurred within 6 months after completion of adequate BCG treatment; 3) T1 high-grade disease was present at the first disease assessment after completion of a BCG induction course. Adequate BCG treatment (minimum treatment requirement) : at least 5 out of 6 full dose treatments were received during the initial induction course and at least 1 maintenance treatment within 6 months (one full dose per week and 2 out of 3 completed treatments); Or received at least 5 out of 6 full doses in the initial induction course and at least 2 out of 6 full doses in the second induction course.
- Relapse after inadequate BCG treatment: Subjects must meet the following criteria: Recurrence of high-grade Ta/T1 disease within 12 months of completion of BCG treatment (as defined below): Previous inadequate BCG treatment (minimum treatment requirement) included receiving at least 5 out of 6 full dose treatments during the initial induction course. Or received at least 5 out of 6 full dose treatments during the initial induction course and at least 1 maintenance treatment (once a week and 2 out of 3 completed treatments) within 6 months. One half or one third of the dose is allowed during maintenance treatment.
- To refuse or be unsuitable for radical cystectomy
- ECOG 0~1
- The major organs are functioning normally, the following criteria are met:
- The blood routine examination criteria should meet (no blood transfusion and no treatment with granulocyte colony stimulating factor within 14 days before enrollment) : i. Absolute count of neutrophils (ANC) ≥1,000/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥ 8.0g /dL (2) Liver function: i. Total bilirubin ≤1.5× prescribed ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5×ULN ii. Upper limit of normal values (ULN) ≤2.5 times of alanine Aminotransferase (ALT) and aspartate Aminotransferase (AST) Note: ≤1.5× ULN (This criterion only applies to patients who have not received anticoagulant therapy; Patients receiving anticoagulant therapy should keep anticoagulants within therapeutic limits); (3) Kidney function: The Cockcroft-Gault formula was used to determine the creatinine clearance (CrCl) > 30 mL/min.
- 8. 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; 9. Fertile women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the study drug is first administered.
Who cannot join
- Confirmed by histology of muscular layer infiltration (T2 or higher level) bladder urothelial carcinoma.
- Histopathological examination revealed any bladder small cell composition, pure, pure squamous cell carcinoma or simple squamous adenocarcinoma CIS;
- Received other PD - 1 / PD - L1 inhibitor and/or HER2 inhibitor;
- Active malignancies other than the disease being treated (i.e., disease progression within the last 24 months or requiring a change in treatment). Only the following special circumstances are allowed: i. Skin cancer that has been treated and completely cured within the last 24 months; ii. Adequately treated lobular carcinoma in situ (LCIS) and ductal CIS; iii. A history of local breast cancer and receiving antihormonal drugs or a history of local prostate cancer (N0M0) and receiving androgen blocking therapy.
- History of uncontrolled cardiovascular disease, including: 1) any of the following in the past 3 months: unstable angina, myocardial infarction, ventricular fibrillation, toroidal ventricular tachycardia, cardiac arrest, or known congestive New York Heart Association Class III-IV heart failure, cerebrovascular accident, or transient ischemic attack; 2) Prolonged QTc interval confirmed by ECG evaluation during screening (Fridericia; QTc > 480 ms); 3) Pulmonary embolism or other venous thromboembolism within the past 2 months.
- Pregnancy or lactation women;
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- Known human immunodeficiency virus (HIV) infection, unless the subjects in the past six months or longer had accepted the stability of antiretroviral therapy (art), and no opportunistic infections occurred in the past 6 months, and over the past six months the CD4 count of > 350;
- Have evidence of active hepatitis B or hepatitis C infection (for example, a history of hepatitis C but hepatitis C virus polymerase chain reaction detection results and normal subjects of hepatitis B surface antigen antibody positive hepatitis B can groups);
- Has yet to recover from past the toxic effects of anticancer therapy (except no clinical significance of toxic effects, such as hair loss, skin discoloration, neuropathy, and hearing impairment).
- Wound healing delay, defined as the skin/decubitus ulcer, chronic leg ulcer, had known gastric ulcer or incision to heal.
- 1 cycle day 1 major surgery within 4 weeks before (don't think TURBT belong to major surgery).
- Other patients assessed by the investigator as unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Shanghai Renji Hospital
Shanghai, Shanghai Municipality
Qi Lu, +86021-68383364, rjllb3364@163.com
About this study
Official title: RC48 Combined With Tislelizumab for Bladder Sparing Treatment in High-risk Non-muscular Invasive Bladder Cancer (NMIBC) With BCG Treatment Failure and HER2 Expression
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks).
Subjects undergo Transurethral resection of bladder tumor (TURBT), imaging diagnosis and pre-treatment biological samples of blood, urine and biopsy tissue.
Read more
The study will include high-risk NMIBC patients who express HER2, fail after BCG treatment, but refuse to undergo cystectomy or do not meet the requirements for cystectomy.
Subjects will receive RC48 and Tislelizumab for two years. BI-DFS were evaluated by cystoscopy, histopathologic examination, laboratory examination, and imaging examination after treatment, and tumor efficacy was evaluated when clinical studies reached the number of subjects specified in the protocol for efficacy evaluation.
Read the detailed description
For Non-muscle invasive bladder cancer (NMIBC), Transurethral resection of bladder tumor (TURBT) is the primary treatment. TURBT relapses within 12 months after surgery in 10% to 67% of patients, and postoperative bladder perfusion therapy (including chemotherapy and Immunotherapy) significantly reduces the recurrence rate. However, about 30%-40% of patients will relapse after BCG treatment. Radical cystectomy is the standard of care for patients who do not respond to BCG treatment and have high grade NMIBC. However, radical cystectomy has a high incidence of postoperative complications (up to 60%) and a negative impact on HRQoL. These complications occur even in high-volume centers of excellence, whether open or minimally invasive, and the mortality rate from the surgery itself is about 3%. Therefore, some patients refuse to undergo radical cystectomy. In addition, some patients are medically unfit for surgery due to age, functional status, American Society of Anesthesiologists classification, comorbiditions, body mass index, and other factors. Although penerubicin is the only bladder sparing drug approved by the U.S. Food and Drug Administration (FDA) for patients who are not suitable for or unwilling to undergo cystectomy, BCG refractory, and with CIS NMIBC, no legally marketed penerubicin drug is available in China. Therefore, new treatments are needed to prevent invasive bladder cancer from affecting the entire bladder.
In recent years, immunocheckpoint inhibitors represented by PD-1/PD-L1 have been proved to be a promising means of tumor immunotherapy, which has made a breakthrough in the treatment of advanced urothelial carcinoma, and become the main choice for the treatment of advanced urothelial carcinoma. Immunocheckpoint inhibitors also showed positive results in patients who did not respond to BCG treatment during perioperative and perioperative periods.Therefore, immunotherapy is expected to be an alternative bladder sparing therapy for high-risk NMIBC patients.The anti-HER2-ADC drug RC48 also achieved significant efficacy in HER2-overexpressed advanced urothelial carcinoma, and its combination with PD-1 monoclonal antibody Toripalimab was more effective in the first-line treatment of advanced metastatic urothelial carcinoma. Therefore, RC48 combined with PD-1 can be used as a potential treatment for bladder sparing in patients with NMIBC.
In NMIBC patients with HER2 expression, ADC drugs can target tumor cells and deliver cytotoxic drugs with greater safety than chemotherapy. In addition, the application of anti-HER2-ADC drugs combined with PD-1 in bladder sparing therapy is still lacking in experience and related studies. Therefore, we plan to conduct a study on bladder preservation therapy for patients with HER2-expressing NMIBC treated with ADC drugs combined with PD-1 monoclonal antibody, so as to preserve the bladder function of patients while controlling tumor recurrence and ensuring their quality of life.
- Conditions
- Non-Muscle Invasive Bladder Cancer, HER2
- Being tested
- RC48, Tislelizumab
- Keywords
- Non-Muscle Invasive Bladder Cancer, HER2 expression, BCG Failure, Unsuitable or refused to radical cystectomy
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48Drug
Also called Disitamab Vedotin
RC48 was scheduled to be administered at a dose of 2.0mg/kg every 2 weeks, with the first dose on day 1 of the first cycle.
The drug is diluted with normal saline and administered by intravenous drip for one hour.
TislelizumabDrug
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 group | Role | What they receive |
|---|---|---|
| RC48+Tislelizumab | Experimental | Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks). Receives: Drug: RC48; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-yr Bladder-intact Disease-free Survival (BI-DFS)
Defined by time from enrollment to the occurrence of one of the following events: first MIBC or regional lymph node recurrence, distant metastasis, or death
Measured: Up to 24 months
Secondary outcomes (7)
Time to Progression (TTP)
Defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause.
Measured: Up to 24 months
Time to Deterioration (TTD)
Defined by time from day of first treatment to first deterioration
Measured: Up to 24 months
Cystectomy Free Survival
Defined by time from day of first treatment to radical cystectomy
Measured: Up to 24 months
Disease-Specific Survival (DSS)
Defined by time from day of first treatment to invasive bladder cancer
Measured: Up to 24 months
Overall Survival (OS)
Defined by time from day of first treatment to death
Measured: Up to 24 months
Percent of Patients With Complete Response (CR)
CR is defined by negative cystoscopy, urine cytology, and bladder biopsies.
Measured: Up to 6 months
Recurrence Free Survival (RFS)
Defined by time from day of first treatment to recurrent NMIBC based on cystoscopy, cytology and/or biopsy.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start5 Aug 2023
- Primary completion8 Jun 2026 (estimated)
- Study completion8 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Model description
- To study the safety and efficacy of RC48 combined with Tislelizumab in HER2 expression high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RemeGen Co., Ltd., BeiGene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957757
- Sponsor's protocol ID
- LY-2022-021-B
- Status last verified
- Aug 2023
- First submitted
- 12 May 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RC48 Combined With Tislelizumab for Bladder Sparing Treatment in High-risk Non-muscular Invasive Bladder Cancer (NMIBC) With BCG Treatment Failure and HER2 Expression
- ClinicalTrials.gov ID
- NCT05957757
- Acronym / sponsor ID
- LY-2022-021-B
- Conditions
- Non-Muscle Invasive Bladder Cancer, HER2
- Keywords
- Non-Muscle Invasive Bladder Cancer, HER2 expression, BCG Failure, Unsuitable or refused to radical cystectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- RemeGen Co., Ltd., BeiGene
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 8 Jun 2026 (estimated)
- First posted
- 24 Jul 2023 (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.
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks).
Subjects undergo Transurethral resection of bladder tumor (TURBT), imaging diagnosis and pre-treatment biological samples of blood, urine and biopsy tissue.
The study will include high-risk NMIBC patients who express HER2, fail after BCG treatment, but refuse to undergo cystectomy or do not meet the requirements for cystectomy.
Subjects will receive RC48 and Tislelizumab for two years. BI-DFS were evaluated by cystoscopy, histopathologic examination, laboratory examination, and imaging examination after treatment, and tumor efficacy was evaluated when clinical studies reached the number of subjects specified in the protocol for efficacy evaluation.
Detailed description
For Non-muscle invasive bladder cancer (NMIBC), Transurethral resection of bladder tumor (TURBT) is the primary treatment. TURBT relapses within 12 months after surgery in 10% to 67% of patients, and postoperative bladder perfusion therapy (including chemotherapy and Immunotherapy) significantly reduces the recurrence rate. However, about 30%-40% of patients will relapse after BCG treatment. Radical cystectomy is the standard of care for patients who do not respond to BCG treatment and have high grade NMIBC. However, radical cystectomy has a high incidence of postoperative complications (up to 60%) and a negative impact on HRQoL. These complications occur even in high-volume centers of excellence, whether open or minimally invasive, and the mortality rate from the surgery itself is about 3%. Therefore, some patients refuse to undergo radical cystectomy. In addition, some patients are medically unfit for surgery due to age, functional status, American Society of Anesthesiologists classification, comorbiditions, body mass index, and other factors. Although penerubicin is the only bladder sparing drug approved by the U.S. Food and Drug Administration (FDA) for patients who are not suitable for or unwilling to undergo cystectomy, BCG refractory, and with CIS NMIBC, no legally marketed penerubicin drug is available in China. Therefore, new treatments are needed to prevent invasive bladder cancer from affecting the entire bladder.
In recent years, immunocheckpoint inhibitors represented by PD-1/PD-L1 have been proved to be a promising means of tumor immunotherapy, which has made a breakthrough in the treatment of advanced urothelial carcinoma, and become the main choice for the treatment of advanced urothelial carcinoma. Immunocheckpoint inhibitors also showed positive results in patients who did not respond to BCG treatment during perioperative and perioperative periods.Therefore, immunotherapy is expected to be an alternative bladder sparing therapy for high-risk NMIBC patients.The anti-HER2-ADC drug RC48 also achieved significant efficacy in HER2-overexpressed advanced urothelial carcinoma, and its combination with PD-1 monoclonal antibody Toripalimab was more effective in the first-line treatment of advanced metastatic urothelial carcinoma. Therefore, RC48 combined with PD-1 can be used as a potential treatment for bladder sparing in patients with NMIBC.
In NMIBC patients with HER2 expression, ADC drugs can target tumor cells and deliver cytotoxic drugs with greater safety than chemotherapy. In addition, the application of anti-HER2-ADC drugs combined with PD-1 in bladder sparing therapy is still lacking in experience and related studies. Therefore, we plan to conduct a study on bladder preservation therapy for patients with HER2-expressing NMIBC treated with ADC drugs combined with PD-1 monoclonal antibody, so as to preserve the bladder function of patients while controlling tumor recurrence and ensuring their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To study the safety and efficacy of RC48 combined with Tislelizumab in HER2 expression high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.
| Arm | Type | Receives |
|---|---|---|
| RC48+Tislelizumab | Experimental | Drug: RC48, Drug: TislelizumabApproximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥18 years old
- Histologically confirmed recurrent, non-muscle invasive bladder cancer;
- When BCG recurred after treatment, the presence of HER2 expression was detected by IHC in the pathology department of our hospital
- BCG treatment failure included no response to BCG treatment and relapse after inadequate BCG treatment
- To refuse or be unsuitable for radical cystectomy
Key exclusion criteria (12 listed)
- Confirmed by histology of muscular layer infiltration (T2 or higher level) bladder urothelial carcinoma.
- Histopathological examination revealed any bladder small cell composition, pure, pure squamous cell carcinoma or simple squamous adenocarcinoma CIS;
- Received other PD - 1 / PD - L1 inhibitor and/or HER2 inhibitor;
- Active malignancies other than the disease being treated (i.e., disease progression within the last 24 months or requiring a change in treatment). Only the following special circumstances are allowed: i. Skin cancer that has been treated and completely cured within the last 24 months; ii. Adequately treated lobular carcinoma in situ (LCIS) and ductal CIS; iii. A history of local breast cancer and receiving antihormonal drugs or a history of local prostate cancer (N0M0) and receiving androgen blocking therapy.
- History of uncontrolled cardiovascular disease, including: 1) any of the following in the past 3 months: unstable angina, myocardial infarction, ventricular fibrillation, toroidal ventricular tachycardia, cardiac arrest, or known congestive New York Heart Association Class III-IV heart failure, cerebrovascular accident, or transient ischemic attack; 2) Prolonged QTc interval confirmed by ECG evaluation during screening (Fridericia; QTc > 480 ms); 3) Pulmonary embolism or other venous thromboembolism within the past 2 months.
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 |
|---|---|---|
| RC48Also: Disitamab VedotinRC48 was scheduled to be administered at a dose of 2.0mg/kg every 2 weeks, with the first dose on day 1 of the first cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour. | Drug | RC48+Tislelizumab |
| TislelizumabTislelizumab 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. | Drug | RC48+Tislelizumab |
Primary outcome
2-yr Bladder-intact Disease-free Survival (BI-DFS)
Time frame: Up to 24 months
Defined by time from enrollment to the occurrence of one of the following events: first MIBC or regional lymph node recurrence, distant metastasis, or death
7 secondary outcomes
Time to Progression (TTP)
Time frame: Up to 24 months
Time to Deterioration (TTD)
Time frame: Up to 24 months
Cystectomy Free Survival
Time frame: Up to 24 months
Disease-Specific Survival (DSS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Percent of Patients With Complete Response (CR)
Time frame: Up to 6 months
Recurrence Free Survival (RFS)
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
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 RC48 and Tislelizumab in people with Non-Muscle Invasive Bladder Cancer and HER2, 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 14 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xue, Doctor (02168383575, xuewei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-yr Bladder-intact Disease-free Survival (BI-DFS) (time frame: Up to 24 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 31 Aug 2023.