Bladder CancerPhase 2NCT05531123
Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer
A Phase 2 study testing Tislelizumab, gemcitabine and cisplatin and Modified hypofractionation in people with Bladder Cancer, run by Fudan University at 1 site in China.
Trial summary
Neoadjuvant chemotherapy plus radical cystectomy is the standard if care for cisplatin-eligible patients with MIBC. Developments in the last two decades suggest that bladder sparing therapy may be a valuable alternative to radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Tislelizumab, gemcitabine and cisplatin and Modified hypofractionation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2022to 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 and ≤ 85;
- People who want to protect their bladder;
- ECOG PS 0 2 points;
- Subject underwent TURBT surgery and imaging diagnosis of musculothelial invasive bladder urothelial carcinoma (histologic variation accepted, not diffuse CIS lesion);
- Accept maximum TURBT;
- Clinical stages T2-4A, N0-1, M0;
Show all 13Show fewer
- Normal function of major organs (14 days prior to enrollment), i.e. meeting the following criteria:
- Blood routine examination criteria should be met (no blood transfusion and no granulocyte colony were received within 14 days before enrollment Stimulator therapy) :
- HB 90 g/L or higher The ANC acuity 1.5 x 109 / L PLT acuity 100 x 109 / L
- No functional organic disease, the following criteria should be met:
- T-bil ≤1.5×ULN upper limit of normal value ALT and AST≤2.5×ULN If liver metastasis, ALT and AST≤5×ULN Estimated glomerular filtration rate (EGFR 60mL /min MdRD formula) International standardized ratio (INR), activated partial thrombin time aPTT ≤1.5× ULN(this standard is only applicable to patients who did not receive anticoagulant therapy; On anticoagulant therapy Patients should keep anticoagulants within the therapeutic range)
- Men who are fertile or women who are likely to become pregnant must use highly fertile men or women who are likely to become pregnant during the trial, Must be used in the testing process highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive device, abstemious sexual desire or barrier contraception effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive device, abstemious sexual desire or barrier contraceptive method combined with spermicide), and at the end of the treatment to birth control in combination with spermicide), and birth control for 12 months after the end of the treatment;
- Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up. The subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Who cannot join
- Previously received anti-PD-1, anti-PD-L1, and anti-PD-L2 therapy;
- Known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
- Received other antineoplastic therapy (including but not limited to corticosteroids) within 4 weeks prior to study therapy;
- Alcohol therapy, immunotherapy) or other clinical studies, or have not yet recovered from the previous toxicity (except 2 degree hair loss and 1 degree neurotoxicity);
- Women who are pregnant or breast-feeding, and women who wish to have children (pelvic radiation may cause ovarian function Premature aging);
- HIV positive;
Show all 20Show fewer
- Patients with active hepatitis B or C; HBsAg or HBcAb positive patients were also detected with positive HBV DNA copy number (quantitative). The detection limit is 500IU/ml, or reaches the positive copy number detected by the research center); For such patients study screening must test for HBV DNA; HCV antibody test results are positive for patients, only when HCV RNA PCR test results. If it is negative, it can be included in this study;
- A clear history of active tuberculosis;
- Have active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., using disease modulations);
- Section drugs, corticosteroids, or immunosuppressive drugs), allowing for relevant alternative therapies (e.g., thyroid Hormone, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency);
- Other serious, uncontrolled comorbidities that may affect protocol compliance or interfere with interpretation of results;
- Diseases, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes, cardiovascular disease (Defined by the New York Heart Association classification as grade ⅲ or ⅳ heart failure, grade ⅱ or higher heart, visceral block, myocardial infarction in the past 6 months, unstable arrhythmia or instability, angina pectoris, cerebral infarction within 3 months, etc.) or lung diseases (interstitial pneumonia, obstructive pulmonary disease; History of pulmonary disease and symptomatic bronchial spasm);
- Received live vaccine within 4 weeks prior to the start of treatment;
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Those who have a history of abuse of psychotropic substances and cannot quit or have a history of mental disorders; Those who have a history of psychotropic drug abuse and cannot quit or have a history of mental disorders;
- Large pleural or ascites with clinical symptoms or requiring symptomatic management; Large pleural or ascites with clinical symptoms or symptomatic management;
- In the past five years have suffered from other malignant tumors, not cured but does not include has obvious cured malignant swell years suffered from other malignant tumors, not cured but does not include has obvious cure of malignant tumor, or can cure cancer, such as basal skin cancer or squamous cell cancer, limitations before low-risk tumor, or can be a cure for cancer, Such as basal or squamous cell skin cancer, localized low-risk prostate cancer, cervical carcinoma in situ or breast carcinoma in situ; Remarks: Localized low-risk prostate cancer (defined as adenocarcinoma, carcinoma in situ of the cervix, or carcinoma in situ of the breast; Remark: Limits (defined as low-risk prostate cancer stage for stage or less T2a, gleason score, gleason scores six points or less, and diagnosis of prostate cancer and prostate cancer diagnosis in the PSA 10 ng/mL or less (such as test (e.g., measurement) of the patients received radical amount) of the patients received radical surgery operation and without prostate specific antigen (and prostate specific antigen (P SA)) biochemical relapses biochemical relapses may participate in this study); Participants may participate in this study);
- Previous history of pelvic radiation therapy; Previous history of pelvic radiation therapy;
- Merged UTUC or urethral cancer
- May increase risks associated with study participation, or may interfere with study participation, according to the researchers. Any other serious, acute or chronic medical or mental illness or laboratory abnormality that may increase the risk associated with study participation or that may interfere with the interpretation of study results or the interpretation of laboratory findings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Phase II Study of Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer After Chemotherapy Combined With PD-1 Antibody(Rebirth)
Neoadjuvant chemotherapy plus radical cystectomy is the standard if care for cisplatin-eligible patients with MIBC. Developments in the last two decades suggest that bladder sparing therapy may be a valuable alternative to radical cystectomy. Currently, well-documented TMT regimens, which include complete transurethral resection of bladder tumor (TURBT), chemotherapy, and radiation therapy, demonstrated durable oncologic control and long-term survival in selected patients. Nevertheless, TMT has not been widely used in clinical practice. On the one hand, due to the complexity of TMT, multiple clinical departments are required to cooperate in the assessment, treatment and follow-up of patients. On the other hand, concerns about tumor recurrence, lack of surgical intervention in regional lymph nodes, and organ dysfunction due to the treatment of large doses of pelvic radiation have reduced the clinical acceptance of TMT. In recent years, immunocheckpoint inhibitors such as PD-1/L1, including Nivolumab, Pembrolizumab, and Tislelizumab, have proven to be promising immunotherapy approaches for advanced urothelium cancer, leading to breakthroughs in the treatment of advanced urothelium cancer. Immunocheckpoint inhibitors also showed positive efficacy in patients who did not respond to BCG treatment during perioperative period. Therefore, immunotherapy can be another means of bladder preservation after surgery, chemotherapy and radiotherapy. However, bladder sparing target population is still unclear, among which, the NCCN guidelines recommend patients suitable for bladder preservation: T2-3N0M0, single lesion (longest diameter less than 6 cm), histological type of urothelial carcinoma, no CIS, and no hydronephrosis. Therefore, the focus of bladder preservation treatment is not only on the treatment before and during bladder preservation, but also on maximizing the follow-up treatment of TURBT and exploring its long-term benefits based on response to systematic treatment before maximized TURBT.
- Conditions
- Bladder Cancer
- Being tested
- Tislelizumab, gemcitabine and cisplatin, Modified hypofractionation
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab 200 mg I.V. Q3W on the day 1
gemcitabine and cisplatinDrug
Cisplatin 70mg/m2 I.V. Q3W on the day 1, dose fractionation is allowed ;Gemcitabine 1000mg/m2 I.V. Q3W on the day 1 and day 8
Modified hypofractionationRadiation
- Whole bladder 44Gy / 16fractionation (If N1: Whole bladder + Pelvic nodes 44Gy / 16fractionation) (Positive lymph nodes can be dosed to the maximum tolerable dose)
- Tumor boost 11Gy / 4fractionation
- Radiosensitizing chemotherapy: DDP 75-80 mg/m2 weekly Q3W
| Study group | Role | What they receive |
|---|---|---|
| Arm1(cCR=cT0, cTa) | Experimental | Not described Receives: Drug: Tislelizumab |
| Arm2 (non-cCR) | Experimental | Not described Receives: Drug: Tislelizumab; Drug: gemcitabine and cisplatin; Radiation: Modified hypofractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIDFS at one year
BIDFS, bladder intact disease free survival, was defined as the time from the start of regimen until MIBC recurrence, regional pelvic recurrence, distant metastasis, bladder cancer-related death, or cystectomy.
Measured: one year
Secondary outcomes (4)
MFS at two years
MFS, metastatic free survival, was defined as time from the start of regimen to first diagnosis of distant metastasis
Measured: two years
BIDFS at two years
BIDFS, bladder intact disease free survival, was defined as the time from the start of regimen until MIBC recurrence, regional pelvic recurrence, distant metastasis, bladder cancer-related death, or cystectomy.
Measured: two years
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: two years
cCR after first treatment stage
cCR, clinical complete response, defined as cT0, which is clarified as negative cystoscope, negative urine cytology and no disease evidence on imaging at the end of the first phase of treatment, and cTa, which is assessed as papillary bladder cancer by cystoscope, urine cytology and imaging.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start10 Sep 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531123
- Sponsor's protocol ID
- ReBirth-01
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer After Chemotherapy Combined With PD-1 Antibody(Rebirth)
- ClinicalTrials.gov ID
- NCT05531123
- Acronym / sponsor ID
- ReBirth-01
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Sep 2022 (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.
Neoadjuvant chemotherapy plus radical cystectomy is the standard if care for cisplatin-eligible patients with MIBC. Developments in the last two decades suggest that bladder sparing therapy may be a valuable alternative to radical cystectomy. Currently, well-documented TMT regimens, which include complete transurethral resection of bladder tumor (TURBT), chemotherapy, and radiation therapy, demonstrated durable oncologic control and long-term survival in selected patients. Nevertheless, TMT has not been widely used in clinical practice. On the one hand, due to the complexity of TMT, multiple clinical departments are required to cooperate in the assessment, treatment and follow-up of patients. On the other hand, concerns about tumor recurrence, lack of surgical intervention in regional lymph nodes, and organ dysfunction due to the treatment of large doses of pelvic radiation have reduced the clinical acceptance of TMT. In recent years, immunocheckpoint inhibitors such as PD-1/L1, including Nivolumab, Pembrolizumab, and Tislelizumab, have proven to be promising immunotherapy approaches for advanced urothelium cancer, leading to breakthroughs in the treatment of advanced urothelium cancer. Immunocheckpoint inhibitors also showed positive efficacy in patients who did not respond to BCG treatment during perioperative period. Therefore, immunotherapy can be another means of bladder preservation after surgery, chemotherapy and radiotherapy. However, bladder sparing target population is still unclear, among which, the NCCN guidelines recommend patients suitable for bladder preservation: T2-3N0M0, single lesion (longest diameter less than 6 cm), histological type of urothelial carcinoma, no CIS, and no hydronephrosis. Therefore, the focus of bladder preservation treatment is not only on the treatment before and during bladder preservation, but also on maximizing the follow-up treatment of TURBT and exploring its long-term benefits based on response to systematic treatment before maximized TURBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1(cCR=cT0, cTa) | Experimental | Drug: Tislelizumab |
| Arm2 (non-cCR) | Experimental | Drug: Tislelizumab, Drug: gemcitabine and cisplatin, Radiation: Modified hypofractionation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female aged 18 and ≤ 85;
- People who want to protect their bladder;
- ECOG PS 0 2 points;
- Subject underwent TURBT surgery and imaging diagnosis of musculothelial invasive bladder urothelial carcinoma (histologic variation accepted, not diffuse CIS lesion);
- Accept maximum TURBT;
Key exclusion criteria (20 listed)
- Previously received anti-PD-1, anti-PD-L1, and anti-PD-L2 therapy;
- Known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
- Received other antineoplastic therapy (including but not limited to corticosteroids) within 4 weeks prior to study therapy;
- Alcohol therapy, immunotherapy) or other clinical studies, or have not yet recovered from the previous toxicity (except 2 degree hair loss and 1 degree neurotoxicity);
- Women who are pregnant or breast-feeding, and women who wish to have children (pelvic radiation may cause ovarian function Premature aging);
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 |
|---|---|---|
| TislelizumabTislelizumab 200 mg I.V. Q3W on the day 1 | Drug | Arm1(cCR=cT0, cTa), Arm2 (non-cCR) |
| gemcitabine and cisplatinCisplatin 70mg/m2 I.V. Q3W on the day 1, dose fractionation is allowed ;Gemcitabine 1000mg/m2 I.V. Q3W on the day 1 and day 8 | Drug | Arm2 (non-cCR) |
| Modified hypofractionation* Whole bladder 44Gy / 16fractionation (If N1: Whole bladder + Pelvic nodes 44Gy / 16fractionation) (Positive lymph nodes can be dosed to the maximum tolerable dose) * Tumor boost 11Gy / 4fractionation * Radiosensitizing chemotherapy: DDP 75-80 mg/m2 weekly Q3W | Radiation | Arm2 (non-cCR) |
Primary outcome
BIDFS at one year
Time frame: one year
BIDFS, bladder intact disease free survival, was defined as the time from the start of regimen until MIBC recurrence, regional pelvic recurrence, distant metastasis, bladder cancer-related death, or cystectomy.
4 secondary outcomes
MFS at two years
Time frame: two years
BIDFS at two years
Time frame: two years
Treatment-related adverse events
Time frame: two years
cCR after first treatment stage
Time frame: two 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 20 Jul 2026.
Related trials for Bladder Cancer
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 2
Intravesical Gem/Doce in Patients With NMIBC
Urinary Bladder Cancer
Active, not recruitingPhase 3
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Advanced Bladder Urothelial Carcinoma, Advanced Renal Pelvis Urothelial Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tislelizumab, gemcitabine and cisplatin and Modified hypofractionation in people with Bladder Cancer, 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 13 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIDFS at one year (time frame: one year). 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 20 Jul 2026.