xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05975307</url>
    </required_header>
    <id_info>
      <org_study_id>2023-FXY-068</org_study_id>
      <nct_id>NCT05975307</nct_id>
    </id_info>
    <brief_title>Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation</brief_title>
    <acronym>BCIRT-01</acronym>
    <official_title>A Single-arm, Phase II Clinical Trial to Treat Muscle-invasive Bladder Cancer With Induction Chemotherapy Plus Anti-PD-1 Therapy Followed by Radiotherapy Plus Concurrent Anti-PD-1 Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this Phase 2 trial is to evaluate a non-surgical bladder-preserving treatment&#xD;
        mode which consists of induction chemotherapy plus anti-programmed cell death protein 1&#xD;
        (anti-PD-1) therapy followed by radiotherapy plus concurrent anti-PD-1 therapy. The main&#xD;
        questions it aims to answer are: (i) whether the anti-PD-1 antibody, toripalimab, is&#xD;
        effective in treating muscle-invasive bladder cancer (MIBC), when combined with&#xD;
        chemoradiation; (ii) whether toripalimab is safe in combination with chemoradiation.&#xD;
        Participants will receive 3 cycles of induction treatment containing chemotherapy with&#xD;
        gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive&#xD;
        disease will receive radical radiotherapy plus 2 cycles of concurrent toripalimab.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bladder cancer is the second most common malignancies over the world. At initial diagnosis,&#xD;
        the cases with muscle-invasive bladder cancer (MIBC) accounts nearly 20% of all bladder&#xD;
        cancer patients. And 40% of non-muscle-invasive bladder cancer could develop to MIBC.&#xD;
        Currently, radical cystectomy (RC) is the golden standard to manage MIBC. Yet, it brings&#xD;
        severe surgical injuries and post-surgical complications which impair life quality of the&#xD;
        patients. Recently, bladder-preserving treatment based gradually becomes the second choice&#xD;
        for MIBC. It consists of maximal transurethral resection of bladder tumor (TURBT) and&#xD;
        chemoradiation. A series of clinical trials and meta-analyses supported that the&#xD;
        bladder-preserving treatment has a similar therapeutic effect compared with RC. But it is&#xD;
        noteworthy that this treatment mode does not really avoid surgery. TURBT could also cause&#xD;
        complications, such as haemorrhage, infection, perforation, and even tumor dissemination.&#xD;
        Moreover, the incidence of serious toxicities brought by concurrent chemoradiation is as high&#xD;
        as 36%. In actual clinical work, it is hard for more than half patients to complete&#xD;
        chemoradiation of standard intensity. Additionally, many patients are unsuitable for bladder&#xD;
        preservation, including those with T stage &gt; T2, diameter &gt; 5 cm, hydronephrosis and positive&#xD;
        lymph nodes. Hence, it calls for improvement of current bladder preservation mode, to make&#xD;
        more MIBC patients receive radical treatment which brings better therapeutic experience and&#xD;
        life quality.&#xD;
  &#xD;
        Many lab studies indicated that formation and progression of bladder cancer is a process of&#xD;
        mutation accumulation. It provides biological fundamentals for immune checkpoint inhibitors,&#xD;
        such as anti-programmed cell death protein 1 (anti-PD-1) antibodies. Based on available&#xD;
        clinical studies, anti-PD-1 antibodies exhibits ideal therapeutic effects in bladder cancer&#xD;
        of different stages and has an incidence of toxicities as low as 13%. Its toxicities mainly&#xD;
        include arthralgia and hyponatremia, which are well tolerated. Currently, there are more than&#xD;
        10 clinical trials trying anti-PD-1 antibodies for bladder preservation. However, the&#xD;
        treatment modes in most of them still contain TURBT. This phase 2 trial intended to evaluate&#xD;
        the therapeutic and adverse effects of a non-surgical bladder-preserving treatment mode&#xD;
        consisting of anti-PD-1 antibodies and chemoradiation, in a small patient cohort with MIBC.&#xD;
        The results might provide an effective, non-invasive and low-toxic choice which improves&#xD;
        patient experience and realizes bladder preservation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This Phase 2 trial uses a single-arm, Simon's two-stage design.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical complete response (cCR) rate</measure>
      <time_frame>When the eligible patients complete the treatment and followed-up for half a year</time_frame>
      <description>The percentage of the cases attaining cCR of primary tumor and regional lymph nodes (confirmed by radiography and cystoscopy)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pathological complete response (pCR) rate</measure>
      <time_frame>When the eligible patients complete the treatment and followed-up for half a year</time_frame>
      <description>The percentage of the cases attaining pCR of primary tumor (confirmed by multipoint biopsy under cystoscopy)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>When the eligible patients complete the treatment and followed-up for 1 and 2 years</time_frame>
      <description>The percentage of the cases surviving over a given time period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bladder-intact event-free survival (BI-EFS)</measure>
      <time_frame>When the eligible patients complete the treatment and followed-up for 1 and 2 years</time_frame>
      <description>The percentage of the cases surviving with intact bladder and without muscle-invasive recurrence, regional lymph node recurrence or distant metastasis, over a given time period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival (DFS)</measure>
      <time_frame>When the eligible patients complete the treatment and followed-up for 1 and 2 years</time_frame>
      <description>The percentage of the cases surviving without locoregional recurrence or distant metastasis over a given time period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Local recurrence (LR) rate</measure>
      <time_frame>When the eligible patients complete the treatment and followed-up for 1 and 2 years</time_frame>
      <description>The percentage of the cases with locoregional recurrence over a given time period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of grade 3/4 (G3/4) acute toxicities</measure>
      <time_frame>Once a week for each patient, until the last day of treatment</time_frame>
      <description>The percentage of the cases with any G3/4 toxicity during the period of treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bladder function</measure>
      <time_frame>Once per 3 months for each patient, until the last follow-up (2 years after treatment)</time_frame>
      <description>The quantitative score of bladder function at a given time point, based on the Quality of Life 30-item Questionnaire, Bladder Module (QLQ-BLM30) from the EORTC</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best objective response rate (ORR)</measure>
      <time_frame>A week before radiotherapy, a week before boost radiation, and once per 3 months until the last follow-up (2 years after treatment)</time_frame>
      <description>The percentage of the cases attaining clinical complete or partial response of primary tumor and regional lymph nodes (confirmed by radiography and cystoscopy)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Muscle-Invasive Bladder Carcinoma</condition>
    <condition>Programmed Cell Death Protein 1 Inhibitor</condition>
    <condition>Radiotherapy</condition>
    <arm_group>
      <arm_group_label>Toripalimab plus chemoradiation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study has only single arm in which the patients will receive induction chemotherapy plus anti-PD-1 therapy (toripalimab), followed by radiotherapy plus concurrent anti-PD-1 therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Toripalimab</intervention_name>
      <description>The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.&#xD;
  Toripalimab: 240 mg on Day 1, every 3 weeks, totally 3 and 2 cycles in the induction and concurrent phases, respectively.</description>
      <arm_group_label>Toripalimab plus chemoradiation</arm_group_label>
      <other_name>JS001</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.&#xD;
  Gemcitabine: 1 g/m2 on Days 1 and 8, repeated every 3 weeks, totally 3 cycles.</description>
      <arm_group_label>Toripalimab plus chemoradiation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.&#xD;
  Cisplatin: Used when creatinine clearance rate ≥ 40 ml/min, 37.5 mg/m2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles.</description>
      <arm_group_label>Toripalimab plus chemoradiation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carboplatin</intervention_name>
      <description>The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.&#xD;
  Cisplatin: Used when creatinine clearance rate &lt; 40 ml/min, area under curve = 2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles.</description>
      <arm_group_label>Toripalimab plus chemoradiation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Intensity-modulated radiation therapy</intervention_name>
      <description>The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.&#xD;
  Radiotherapy: performed by using the technique of intensity-modulated radiation therapy, with a total dose of 65 and 45 Gy for the gross tumor and lymphatic drainage regions.</description>
      <arm_group_label>Toripalimab plus chemoradiation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pathologically diagnosed bladder malignant tumor via biopsy&#xD;
  &#xD;
            -  Urothelial carcinoma as the primary histological component&#xD;
  &#xD;
            -  Pretreatment clinical TNM stage as T2-4aN0M0 or T1-4aN1-2M0 (UICC TNM staging&#xD;
               classification, version 8)&#xD;
  &#xD;
            -  Age between 18 and 75 years old&#xD;
  &#xD;
            -  Karnofsky performance score ≥ 70&#xD;
  &#xD;
            -  Creatinine clearance rate ≥ 30 ml/min&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Simultaneous tumors of the urethra or upper urinary tract&#xD;
  &#xD;
            -  Existence of small cell cancer component&#xD;
  &#xD;
            -  Uncontrolled tuberculosis, viral hepatitis or AIDS&#xD;
  &#xD;
            -  Autoimmune or mental diseases&#xD;
  &#xD;
            -  Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for&#xD;
               chemotherapy, radiotherapy or immune checkpoint inhibiting therapy&#xD;
  &#xD;
            -  Prior history of other malignancies within 5 years, except cured cervical carcinoma in&#xD;
               situ and skin basal cell carcinoma&#xD;
  &#xD;
            -  Prior history of pelvic radiotherapy or chemotherapy&#xD;
  &#xD;
            -  Poor adherence to regular follow-up (cystoscopy, CT, MRI, etc.)&#xD;
  &#xD;
            -  Pregnant or lactating women&#xD;
  &#xD;
            -  Treatment with glucocorticoid or immunosuppressive drugs within 1 month&#xD;
  &#xD;
            -  Other situations for which the investigators consider a patient inappropriate to&#xD;
               participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yuanhong Gao, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hui Chang, MD</last_name>
      <phone>+86-020-87343374</phone>
      <email>changhui@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cancer Center, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hui Chang, MD</last_name>
        <phone>+86-020-87343374</phone>
        <email>changhui@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Yuan-hong Gao</investigator_full_name>
      <investigator_title>Vice Director of the Department of Radiation Oncology, Cancer Center</investigator_title>
    </responsible_party>
    <keyword>Bladder Cancer</keyword>
    <keyword>Programmed Cell Death Protein 1 Inhibitor</keyword>
    <keyword>Radiotherapy</keyword>
    <keyword>Chemotherapy</keyword>
    <keyword>Bladder Preservation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carboplatin</mesh_term>
      <mesh_term>Gemcitabine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05975307
  org study id: 2023-FXY-068
  nct id: NCT05975307
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this Phase 2 trial is to evaluate a non-surgical bladder-preserving treatment
        mode which consists of induction chemotherapy plus anti-programmed cell death protein 1
        (anti-PD-1) therapy followed by radiotherapy plus concurrent anti-PD-1 therapy. The main
        questions it aims to answer are: (i) whether the anti-PD-1 antibody, toripalimab, is
        effective in treating muscle-invasive bladder cancer (MIBC), when combined with
        chemoradiation; (ii) whether toripalimab is safe in combination with chemoradiation.
        Participants will receive 3 cycles of induction treatment containing chemotherapy with
        gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive
        disease will receive radical radiotherapy plus 2 cycles of concurrent toripalimab.
  Bladder cancer is the second most common malignancies over the world. At initial diagnosis,
        the cases with muscle-invasive bladder cancer (MIBC) accounts nearly 20% of all bladder
        cancer patients. And 40% of non-muscle-invasive bladder cancer could develop to MIBC.
        Currently, radical cystectomy (RC) is the golden standard to manage MIBC. Yet, it brings
        severe surgical injuries and post-surgical complications which impair life quality of the
        patients. Recently, bladder-preserving treatment based gradually becomes the second choice
        for MIBC. It consists of maximal transurethral resection of bladder tumor (TURBT) and
        chemoradiation. A series of clinical trials and meta-analyses supported that the
        bladder-preserving treatment has a similar therapeutic effect compared with RC. But it is
        noteworthy that this treatment mode does not really avoid surgery. TURBT could also cause
        complications, such as haemorrhage, infection, perforation, and even tumor dissemination.
        Moreover, the incidence of serious toxicities brought by concurrent chemoradiation is as high
        as 36%. In actual clinical work, it is hard for more than half patients to complete
        chemoradiation of standard intensity. Additionally, many patients are unsuitable for bladder
        preservation, including those with T stage > T2, diameter > 5 cm, hydronephrosis and positive
        lymph nodes. Hence, it calls for improvement of current bladder preservation mode, to make
        more MIBC patients receive radical treatment which brings better therapeutic experience and
        life quality.
  
        Many lab studies indicated that formation and progression of bladder cancer is a process of
        mutation accumulation. It provides biological fundamentals for immune checkpoint inhibitors,
        such as anti-programmed cell death protein 1 (anti-PD-1) antibodies. Based on available
        clinical studies, anti-PD-1 antibodies exhibits ideal therapeutic effects in bladder cancer
        of different stages and has an incidence of toxicities as low as 13%. Its toxicities mainly
        include arthralgia and hyponatremia, which are well tolerated. Currently, there are more than
        10 clinical trials trying anti-PD-1 antibodies for bladder preservation. However, the
        treatment modes in most of them still contain TURBT. This phase 2 trial intended to evaluate
        the therapeutic and adverse effects of a non-surgical bladder-preserving treatment mode
        consisting of anti-PD-1 antibodies and chemoradiation, in a small patient cohort with MIBC.
        The results might provide an effective, non-invasive and low-toxic choice which improves
        patient experience and realizes bladder preservation.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This Phase 2 trial uses a single-arm, Simon's two-stage design.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Clinical complete response (cCR) rate
  time frame: When the eligible patients complete the treatment and followed-up for half a year
  description: The percentage of the cases attaining cCR of primary tumor and regional lymph nodes (confirmed by radiography and cystoscopy)
  measure: Pathological complete response (pCR) rate
  time frame: When the eligible patients complete the treatment and followed-up for half a year
  description: The percentage of the cases attaining pCR of primary tumor (confirmed by multipoint biopsy under cystoscopy)
  measure: Overall survival (OS)
  time frame: When the eligible patients complete the treatment and followed-up for 1 and 2 years
  description: The percentage of the cases surviving over a given time period
  measure: Bladder-intact event-free survival (BI-EFS)
  time frame: When the eligible patients complete the treatment and followed-up for 1 and 2 years
  description: The percentage of the cases surviving with intact bladder and without muscle-invasive recurrence, regional lymph node recurrence or distant metastasis, over a given time period
  measure: Disease-free survival (DFS)
  time frame: When the eligible patients complete the treatment and followed-up for 1 and 2 years
  description: The percentage of the cases surviving without locoregional recurrence or distant metastasis over a given time period
  measure: Local recurrence (LR) rate
  time frame: When the eligible patients complete the treatment and followed-up for 1 and 2 years
  description: The percentage of the cases with locoregional recurrence over a given time period
  measure: Incidence of grade 3/4 (G3/4) acute toxicities
  time frame: Once a week for each patient, until the last day of treatment
  description: The percentage of the cases with any G3/4 toxicity during the period of treatment
  measure: Bladder function
  time frame: Once per 3 months for each patient, until the last follow-up (2 years after treatment)
  description: The quantitative score of bladder function at a given time point, based on the Quality of Life 30-item Questionnaire, Bladder Module (QLQ-BLM30) from the EORTC
  measure: Best objective response rate (ORR)
  time frame: A week before radiotherapy, a week before boost radiation, and once per 3 months until the last follow-up (2 years after treatment)
  description: The percentage of the cases attaining clinical complete or partial response of primary tumor and regional lymph nodes (confirmed by radiography and cystoscopy)
  arm group label: Toripalimab plus chemoradiation
  arm group type: Experimental
  description: This study has only single arm in which the patients will receive induction chemotherapy plus anti-PD-1 therapy (toripalimab), followed by radiotherapy plus concurrent anti-PD-1 therapy
  intervention type: Drug
  intervention name: Toripalimab
  description: The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
  Toripalimab: 240 mg on Day 1, every 3 weeks, totally 3 and 2 cycles in the induction and concurrent phases, respectively.
  arm group label: Toripalimab plus chemoradiation
  other name: JS001
  intervention type: Drug
  intervention name: Gemcitabine
  description: The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
  Gemcitabine: 1 g/m2 on Days 1 and 8, repeated every 3 weeks, totally 3 cycles.
  arm group label: Toripalimab plus chemoradiation
  intervention type: Drug
  intervention name: Cisplatin
  description: The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
  Cisplatin: Used when creatinine clearance rate ≥ 40 ml/min, 37.5 mg/m2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles.
  arm group label: Toripalimab plus chemoradiation
  intervention type: Drug
  intervention name: Carboplatin
  description: The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
  Cisplatin: Used when creatinine clearance rate < 40 ml/min, area under curve = 2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles.
  arm group label: Toripalimab plus chemoradiation
  intervention type: Radiation
  intervention name: Intensity-modulated radiation therapy
  description: The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
  Radiotherapy: performed by using the technique of intensity-modulated radiation therapy, with a total dose of 65 and 45 Gy for the gross tumor and lymphatic drainage regions.
  arm group label: Toripalimab plus chemoradiation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Yuanhong Gao, MD
  role: Principal Investigator
  affiliation: Sun Yat-sen University
  last name: Hui Chang, MD
  phone: +86-020-87343374
  email: changhui@sysucc.org.cn
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Yuan-hong Gao
  investigator title: Vice Director of the Department of Radiation Oncology, Cancer Center
  mesh term: Urinary Bladder Neoplasms
  mesh term: Carboplatin
  mesh term: Gemcitabine