Urinary Bladder NeoplasmsPhase 2CBPTMINCT05445648
Comprehensive Bladder Preservation Therapy on Patients With Muscle Invasive Bladder Cancer
A Phase 2 study testing Tislelizumab Injection, Transurethral resection of bladder tumor and Adjuvant radiotherapy in people with Urinary Bladder Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Nowadays, Immune Checkpoint Inhibitor (ICI) has become one of the new drugs for the treatment of advanced uroepithelial carcinoma. The Food and Drug Administration (FDA) approved ICI for bladder cancer (BC) patients who cannot tolerate cisplatin chemotherapy and whose tumors express programmed cell death protein… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Tislelizumab Injection, Transurethral resection of bladder tumor and Adjuvant radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- Feb 2023to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Voluntary participation in this trial, able to provide a written version of informed consent, and able to understand and agree to comply with the requirements of this study.
- BC patients with cT2-T4aN0M0 tumor/ lymph node/ metastasis (TNM) (AJCC 8th edition) staging based on histopathological confirmation by biopsy specimen and CT/MRI assessment.
- ECOG performance status grade less than or equal to 1
Who cannot join
- Cancer in situ (CIS) confirmed by biopsy pathology.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein 4(CTLA)-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (excluding BCG treatment).
- Received other approved systemic anticancer therapy or systemic immunomodulators within 28 days prior to enrollment.
- Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment
- Received herbal or proprietary Chinese medicine for cancer inhibition within 14 days prior to admission.
- Received live vaccination within 28 days prior to admission.
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- Has need for long-term heavy use of hormones or other immunosuppressive drugs.
- Potassium, sodium, or calcium abnormalities affecting treatment, interstitial lung disease, non-infectious pneumonia, or other uncontrolled systemic diseases, including diabetes, hypertension, or active heart disease.
- Patients with chronic hepatitis B, hepatitis B virus carriers, or active hepatitis C.
- Active, known or suspected autoimmune disease requiring systemic therapy.
- Patients with end-stage renal disease (GFR <15 mL/min) or requiring dialysis.
- Other active neoplastic disease.
- Uncontrolled severe physical or mental illness.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Jinhai Fan, MD, 0086-13259906969, fanjinhai@aliyun.com
About this study
Official title: Immune Checkpoint Inhibitor in Addition to Transurethral Resection of Bladder Cancer (TUBRT) and Radiation Therapy in Patients With cT2-4aN0M0 Bladder Cancer: a Mono-centre Clinical Study
Nowadays, Immune Checkpoint Inhibitor (ICI) has become one of the new drugs for the treatment of advanced uroepithelial carcinoma. The Food and Drug Administration (FDA) approved ICI for bladder cancer (BC) patients who cannot tolerate cisplatin chemotherapy and whose tumors express programmed cell death protein ligand-1 (PD-L1). However, the efficacy of ICI in bladder preservation therapy for muscular invasive bladder cancer (MIBC) is unknown.
With the progressive clinical confirmation of the efficacy of immunotherapy, ICI has moved from second-line to first-line treatment in the indication of advanced unresectable BC. It even has been used in the neoadjuvant and postoperative adjuvant therapy for MIBC and non-muscle invasive bladder cancer (NMIBC) where Bacillus Calmette-Guérin (BCG) therapy has failed. Available studies have shown that neoadjuvant immunotherapy can achieve a pathological complete response (pCR) of 31%-42% for MIBC, regardless of using a single drug or combination, which is higher than that of neoadjuvant chemotherapy, and the incidence of side effects associated with neoadjuvant immunotherapy is lower than that of neoadjuvant chemotherapy, providing an effective treatment option for cisplatin-intolerant patients.
Read more
Studies have shown that radiotherapy leads to immunogenic cell death, which results in the release and presentation of tumor antigens and directs the recruitment and activation of T cells. It also induces increased expression of PD-L1 in tumor cells, which in turn improves the efficacy of immunotherapy. Thus ICI combined with radiotherapy has a synergistic antitumor effect and does not produce serious toxic side effects similar to those associated with chemotherapeutic agents.
This study proposes a novel neoadjuvant immunotherapy-based integrated bladder preservation therapy (neoadjuvant immunotherapy + TURBT + postoperative adjuvant radiotherapy combined with immunotherapy) and investigates the effectiveness and safety of this strategy in bladder preservation treatment strategy.
Read the detailed description
This study aims to investigate the efficacy and safety of a comprehensive immunotherapy-based bladder preservation treatment strategy (neoadjuvant immunotherapy + TURBT + adjuvant radiation therapy (RT) combined with immunotherapy) by implementing a prospective, single-arm, single-center, open clinical trial.
It aims to: 1) assess pCR (pathological complete remission rate) and pathological stage reduction rate of patients with MIBC after neoadjuvant immunotherapy. 2) assess relative risk factors that have an impact on pathological stage reduction rate and pCR. 3) assess bladder preservation rate of MIBC patients after the immunotherapy-based integrated bladder preservation therapy. 4) assess tumor recurrence-free survival, progression-free survival, and tumor-specific and overall survival rates after treatment. 5) To assess the safety of this treatment. 6) To collect tumor tissues from TURBT and study genetic variations as well as the expression of relevant biomarkers.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Tislelizumab Injection, Transurethral resection of bladder tumor, Adjuvant radiotherapy
- 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.
Tislelizumab InjectionDrug
Also called BGB-A317, BeiGene
After patient recruitment, every patient first receives a regimen of tislelizumab injection 200 mg every time , q3w, 4 times in total. Then all patients, if operable, undergo TURBT. The first day after TURBT, patients again start to receives a regimen of tislelizumab Injection 200 mg every time , q3w, 4 times in total. Meanwhile, on the eighth day after TURBT, patients start to receive radiotherapy. The total radiation dosage is 50.4 Gy (patients receive radiotherapy 28 times, dosage being 1.8 Gy every time), with the total radiation dosage on pelvis area being 45 Gy and total radiation dosage on bladder area being 50.4 Gy.
Transurethral resection of bladder tumorProcedure or surgery
After the initial tislelizumab injection regimen, patients undergo clinical assessment and receive transurethral resection of bladder tumor if operable.
Adjuvant radiotherapyRadiation
On the eighth day after TURBT, patients start to receive radiotherapy. The total radiation dosage is 50.4 Gy (patients receive radiotherapy 28 times, dosage being 1.8 Gy every time), with the total radiation dosage on pelvis area being 45 Gy and total radiation dosage on bladder area being 50.4 Gy.
| Study group | Role | What they receive |
|---|---|---|
| patients treated with immunotherapy-based bladder preservation therapy | Experimental | Neoadjuvant immunotherapy + TURBT + postoperative adjuvant radiotherapy combined with immunotherapy. Receives: Drug: Tislelizumab Injection; Procedure: Transurethral resection of bladder tumor; Radiation: Adjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder preservation rate within 1 year, %
The percentage of enrolled patients who didn't receive radical cystectomy 1 year after neoadjuvant immunotherapy (Tislelizumab Injection) started
Measured: 1 year after neoadjuvant immunotherapy (Tislelizumab Injection) started
Pathological complete response rate after neoadjuvant immunotherapy, %
the percentage of enrolled patients who demonstrated pathological complete response after neoadjuvant immunotherapy, confirmed by pathological results of specimen extracted from TURBT.
Measured: right after TURBT and pathological examination of surgical specimen has concluded.
Secondary outcomes (2)
Overall survival time, day
the time from the start of neoadjuvant immunotherapy to 1) death of the patients by any cause; 2) the end of followup if patients are still alive by that time; 3) last follow up date if patients are lost, whichever comes first
Measured: from the start of neoadjuvant immunotherapy to 1) death of the patients by any cause; 2) the end of followup if patients are still alive by that time; 3) last follow up date if patients are lost, whichever comes first, assessed up to 156 weeks
Adverse event
all adverse events ever occurred to enrolled patients from the start of neoadjuvant immunotherapy to the last followup check, coded by MedDra. The severity of adverse effect will be evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Measured: from the start of neoadjuvant immunotherapy to the last followup check, assessed up to 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study startFeb 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Sponsor
- Investigators
- Jinhai Fan, MD, Principal investigator, First affiliated hospital of Xian jiaotong university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445648
- Sponsor's protocol ID
- XJTU1AF2022LSK-012
- Acronym
- CBPTMI
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitor in Addition to Transurethral Resection of Bladder Cancer (TUBRT) and Radiation Therapy in Patients With cT2-4aN0M0 Bladder Cancer: a Mono-centre Clinical Study
- ClinicalTrials.gov ID
- NCT05445648
- Acronym / sponsor ID
- CBPTMI / XJTU1AF2022LSK-012
- Conditions
- Urinary Bladder Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Jul 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.
Nowadays, Immune Checkpoint Inhibitor (ICI) has become one of the new drugs for the treatment of advanced uroepithelial carcinoma. The Food and Drug Administration (FDA) approved ICI for bladder cancer (BC) patients who cannot tolerate cisplatin chemotherapy and whose tumors express programmed cell death protein ligand-1 (PD-L1). However, the efficacy of ICI in bladder preservation therapy for muscular invasive bladder cancer (MIBC) is unknown.
With the progressive clinical confirmation of the efficacy of immunotherapy, ICI has moved from second-line to first-line treatment in the indication of advanced unresectable BC. It even has been used in the neoadjuvant and postoperative adjuvant therapy for MIBC and non-muscle invasive bladder cancer (NMIBC) where Bacillus Calmette-Guérin (BCG) therapy has failed. Available studies have shown that neoadjuvant immunotherapy can achieve a pathological complete response (pCR) of 31%-42% for MIBC, regardless of using a single drug or combination, which is higher than that of neoadjuvant chemotherapy, and the incidence of side effects associated with neoadjuvant immunotherapy is lower than that of neoadjuvant chemotherapy, providing an effective treatment option for cisplatin-intolerant patients.
Studies have shown that radiotherapy leads to immunogenic cell death, which results in the release and presentation of tumor antigens and directs the recruitment and activation of T cells. It also induces increased expression of PD-L1 in tumor cells, which in turn improves the efficacy of immunotherapy. Thus ICI combined with radiotherapy has a synergistic antitumor effect and does not produce serious toxic side effects similar to those associated with chemotherapeutic agents.
This study proposes a novel neoadjuvant immunotherapy-based integrated bladder preservation therapy (neoadjuvant immunotherapy + TURBT + postoperative adjuvant radiotherapy combined with immunotherapy) and investigates the effectiveness and safety of this strategy in bladder preservation treatment strategy.
Detailed description
This study aims to investigate the efficacy and safety of a comprehensive immunotherapy-based bladder preservation treatment strategy (neoadjuvant immunotherapy + TURBT + adjuvant radiation therapy (RT) combined with immunotherapy) by implementing a prospective, single-arm, single-center, open clinical trial.
It aims to: 1) assess pCR (pathological complete remission rate) and pathological stage reduction rate of patients with MIBC after neoadjuvant immunotherapy. 2) assess relative risk factors that have an impact on pathological stage reduction rate and pCR. 3) assess bladder preservation rate of MIBC patients after the immunotherapy-based integrated bladder preservation therapy. 4) assess tumor recurrence-free survival, progression-free survival, and tumor-specific and overall survival rates after treatment. 5) To assess the safety of this treatment. 6) To collect tumor tissues from TURBT and study genetic variations as well as the expression of relevant biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated with immunotherapy-based bladder preservation therapy | Experimental | Drug: Tislelizumab Injection, Procedure: Transurethral resection of bladder tumor, Radiation: Adjuvant radiotherapyNeoadjuvant immunotherapy + TURBT + postoperative adjuvant radiotherapy combined with immunotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Voluntary participation in this trial, able to provide a written version of informed consent, and able to understand and agree to comply with the requirements of this study.
- BC patients with cT2-T4aN0M0 tumor/ lymph node/ metastasis (TNM) (AJCC 8th edition) staging based on histopathological confirmation by biopsy specimen and CT/MRI assessment.
- ECOG performance status grade less than or equal to 1
Key exclusion criteria (14 listed)
- Cancer in situ (CIS) confirmed by biopsy pathology.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein 4(CTLA)-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (excluding BCG treatment).
- Received other approved systemic anticancer therapy or systemic immunomodulators within 28 days prior to enrollment.
- Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment
- Received herbal or proprietary Chinese medicine for cancer inhibition within 14 days prior to admission.
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 |
|---|---|---|
| Tislelizumab InjectionAlso: BGB-A317, BeiGeneAfter patient recruitment, every patient first receives a regimen of tislelizumab injection 200 mg every time , q3w, 4 times in total. Then all patients, if operable, undergo TURBT. The first day after TURBT, patients again start to receives a regimen of tislelizumab Injection 200 mg every time , q3w, 4 times in total. Meanwhile, on the eighth day after TURBT, patients start to receive radiotherapy. The total radiation dosage is 50.4 Gy (patients receive radiotherapy 28 times, dosage being 1.8 Gy every time), with the total radiation dosage on pelvis area being 45 Gy and total radiation dosage on bladder area being 50.4 Gy. | Drug | patients treated with immunotherapy-based bladder preservation therapy |
| Transurethral resection of bladder tumorAfter the initial tislelizumab injection regimen, patients undergo clinical assessment and receive transurethral resection of bladder tumor if operable. | Procedure or surgery | patients treated with immunotherapy-based bladder preservation therapy |
| Adjuvant radiotherapyOn the eighth day after TURBT, patients start to receive radiotherapy. The total radiation dosage is 50.4 Gy (patients receive radiotherapy 28 times, dosage being 1.8 Gy every time), with the total radiation dosage on pelvis area being 45 Gy and total radiation dosage on bladder area being 50.4 Gy. | Radiation | patients treated with immunotherapy-based bladder preservation therapy |
Primary outcome
Bladder preservation rate within 1 year, %
Time frame: 1 year after neoadjuvant immunotherapy (Tislelizumab Injection) started
The percentage of enrolled patients who didn't receive radical cystectomy 1 year after neoadjuvant immunotherapy (Tislelizumab Injection) started
Pathological complete response rate after neoadjuvant immunotherapy, %
Time frame: right after TURBT and pathological examination of surgical specimen has concluded.
the percentage of enrolled patients who demonstrated pathological complete response after neoadjuvant immunotherapy, confirmed by pathological results of specimen extracted from TURBT.
2 secondary outcomes
Overall survival time, day
Time frame: from the start of neoadjuvant immunotherapy to 1) death of the patients by any cause; 2) the end of followup if patients are still alive by that time; 3) last follow up date if patients are lost, whichever comes first, assessed up to 156 weeks
Adverse event
Time frame: from the start of neoadjuvant immunotherapy to the last followup check, assessed up to 156 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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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.
Jinhai Fan, MD principal investigator
First affiliated hospital of Xian jiaotong 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 Tislelizumab Injection, Transurethral resection of bladder tumor and Adjuvant radiotherapy in people with Urinary Bladder Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong 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 4 inclusion and 14 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 28 Dec 2022. 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 Jinhai Fan, MD (0086-13259906969, fanjinhai@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder preservation rate within 1 year, % (time frame: 1 year after neoadjuvant immunotherapy (Tislelizumab Injection) started). The study lists 2 primary outcomes in all. 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 28 Dec 2022.