Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

During the induction phase, MK-3475 200 mg will be administered as four cycles of 3-weeks regimen, with ASG-22CE 1.25 mg/kg administered on Day 1 and Day 8 of each cycle. The treatment and maintenance phases will consist of 9 cycles of one course per 6 weeks, with MK-3475 400 mg administered on Day 1 of each course at Q6W.

MK-3475

During the induction phase, four cycles of 3-weeks regimen are administered, with ASG-22CE 1.25 mg/kg administered on Day 1 and Day 8 of each cycle.

ASG-22CE

All participants who were not determined to have PD on imaging during the induction phase should have had a maximal TURBT performed at 13 (± 1week) weeks after the first dose of trial drug.

maximal TURBT

Radiotherapy will be initiated no later than 8 weeks after maximal TUR-BT. In this trial, a total dose of 56 Gy will be delivered using 2 Gy per dose. 40 Gy/20 fr (2 Gy/fr) to the small pelvis followed by 16 Gy /8 fr (2 Gy/fr) to the whole bladder 5 times a week for 5 consecutive days using Three-Dimensional Conformal Radiation Therapy (3D-CRT).

Radiation therapy

Yuki Kita, MD,PhD

Takashi Kobayashi, MD,PhD

This study is designed to assess the efficacy and safety of induction therapy with MK-3475 and ASG-22CE and radiation therapy with MK-3475 in patients with cT2-4aN0M0 muscle invasive bladder cancer who are unfit for or refuse radical cystectomy.

Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)

A Phase 2, Open-label, Multi-institutional Study to Evaluate the Efficacy of Induction Therapy With MK-3475 and ASG-22CE Followed by Radiation Therapy With MK-3475 in Patients With MIBC Who Are Unfit for or Refuse Radical Cystectomy

To evaluate bladder intact event-free survival (BI-EFS) rate at 2 year after study enrollment assessed by cystoscopy, cytology, biopsy results by central pathology review, and imaging evaluation.

The pathologic complete response rate is based on the central pathology review of tumor bed biopsies performed at 38 weeks and the results of imaging studies performed by each institution.

OS is defined as the time from study enrollment to death from any cause.

Metastasis-free survival is defined as the time from study enrollment to the first documented evidence of nodal or distant metastases as assessed by CT of chest and CTU or MRU of the abdomen and pelvis and/or biopsy results assessed by central pathology review, or death from any cause. If biopsy is not feasible due to participant safety, the imaging alone will be sufficient.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.

The BCI is a validated, condition-specific health questionnaire assessing quality of life among participants with bladder cancer. The BCI contains 36 items which assess 3 domains (urinary, bowel, and sexual) with function and bother subdomains. Scores range from 0 to 100 with higher scores corresponding to better functioning and health-related quality of life. The change from baseline in the combined scores of the urinary, bowel, and sexual domains of the BCI will be presented.

The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD in Global Health Status/Quality of Life is defined as the time from baseline to the first onset of a 10 point or greater decrease from baseline in the Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score, with or without subsequent confirmation.

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a better quality of life. TTD in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores.

The BCI is a validated, condition-specific health questionnaire assessing quality of life among participants with bladder cancer. The BCI contains 36 items which assess 3 domains (urinary, bowel, and sexual) with function and bother subdomains. Scores range from 0 to 100 with higher scores corresponding to better functioning and health-related quality of life. TTD in BCI is defined as a 6, 7, and 7 points or greater worsening from baseline for urinary, bowel, and sexual domains, respectively, with or without subsequent confirmation, under a right-censoring rule.

The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD in EQ-5D-5L VAS is defined as the time from baseline to the first onset of a 7 point or greater decrease from baseline in EQ-5D-5L VAS, with or without subsequent confirmation, under a right-censoring rule.

University of Tsukuba

Osaka Metropolitan University

Kobe City Medical Center General Hospital

Merck Sharp & Dohme LLC

Astellas Pharma Inc

Kyoto University Hospital

Professor

Durvalumab

Tremelimumab

The treatment consisted of initial TUR of the tumor, with multiple random biopsies of normal-appearing bladder urothelium, followed by durvalumab 1500 mg i.v. plus tremelimumab 75 mg i.v., every 4 weeks for a total of 3 doses.

Two weeks after the initiation of immunotherapy, normofractionated external-beam radiotherapy with high-energy photons will be started. Radiotherapy will be administered concurrently with immunotherapy at doses of 46 Gy to the minor pelvis and 64-66 Gy to the bladder.

All patients will receive durvalumab (MEDI4736) (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) for up to 3 doses/cycles each, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30kg or below the patient should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W and 1mg/kg tremelimumab Q4W until the weight improves to \>30 kg, at which point the patient should start receiving the fixed dosing of durvalumab 1500mg plus tremelimumab 75 mg Q4W.

Radiotherapy at doses of 46 Gy to the minor pelvis and 64-66 Gy to the bladder.

Radiotherapy

Xavier García del Muro, M.D.

Combined-modality treatment of localized muscle invasive bladder cancer including transurethral resection (TUR), radiotherapy and dual checkpoint inhibition immunotherapy could achieve pathological complete response in some patients. These patients could avoid to undergone radical surgery with radical cystectomy and preserve their bladder, without the side-effects associated with chemotherapy and surgery. This study has been design to determine the efficacy of durvalumab plus tremelimumab with concurrent radiotherapy in terms of pathological response rate in patients with localized muscle invasive bladder cancer treated with bladder preservation intent.

The treatment consisted of initial TUR of the tumor, with multiple random biopsies of normal-appearing bladder urothelium, followed by durvalumab 1500 mg i.v. plus tremelimumab 75 mg i.v., every 4 weeks for a total of 3 doses.

Two weeks after the initiation of immunotherapy, normofractionated external-beam radiotherapy with high-energy photons will be started. Radiotherapy will be administered concurrently with immunotherapy at doses of 46 Gy to the minor pelvis and 64-66 Gy to the bladder.

Six weeks after the end of radiotherapy, ALL patients will undergo a new cystoscopy with biopsies of the tumor bed and all residual present lesions as an efficacy determination. In patients with persistent prominent inflammatory reaction at this moment, the cystoscopy can be performed 1-2 weeks later (6 to 8 weeks after the end of radiotherapy). Response is defined as an absence of invasive cancer at post immunotherapy biopsy (≤cT1). Patients with response to immunotherapy will be candidates to bladder preservation, whereas in those with residual muscle invasive tumor the possibility of salvage radical cystectomy must be evaluated. Patients developing an isolated bladder invasive relapse during follow-up will be also possible candidates to salvage cystectomy, whereas those developing a superficial relapse in the preserved bladder will be managed with TUR and intravesical BCG.

Patients will be followed up every 3 months the first year, every 4 months the second year and every 6 months thereafter with abdomen and pelvis CT scan, Rx thorax, urine cytology. Additionally, the mandatory efficacy cystoscopy and bladder biopsy (6w post RT), other cystoscopy and bladder biopsy will be performed in case of detection abnormalities in the cytology or imaging studies. The study will be closed 2 years after the last patient inclusion.

The study will be conducted using a two-stage sequential design. Using the assumption that the treatment would be considered ineffective if it had a response proportion similar to radiotherapy alone (P0: 0.5) but would be of considerable interest if it had a response proportion of 70% of more (P1: 0.7), the sample size requirement is 12 patients for the first stage and 20 additional patients for the second stage. Six or more responses in the first stage were required for continuation to second stage accrual. The study was planned to have a type I error of 0.10 and a power of 80% in a one sided test.

Durvalumab Plus Tremelimumab With Concurrent Radiotherapy for Localized Muscle Invasive Bladder Cancer Treated With a Selective Bladder Preservation Approach

Phase II Trial of Durvalumab (Medi4736) Plus Tremelimumab With Concurrent Radiotherapy in Patients With Localized Muscle Invasive Bladder Cancer Treated With a Selective Bladder Preservation Approach

Pathological response is defined as the absence of muscle- invasive bladder cancer at post-treatment biopsy (≤cT1). Cystoscopy and bladder biopsy six weeks since the end of radiotherapy.

Number of patients whom bladder has been preserved after cytoscopic evaluation.

Number of patients with indication of salvage cystectomies after first trial-related cystoscopic evaluation.

Number of patients with indication of salvage cystectomies based on follow-up cystoscopic evaluation.

Time from the start of immunotherapy to either the date of cystectomy or the date of recurrence of muscle- invasive bladder carcinoma or metastasis.

Time from the start of therapy to the date of recurrence of muscle invasive bladder carcinoma or metastases.

Time from the start of immunotherapy to the date of death due to any cause.

Frequency, nature and number of patients developing adverse events throughout follow up

AstraZeneca

MFAR

Spanish Oncology Genito-Urinary Group

Symptoms and General Pathology

Death

Carcinoma

Gemcitabine

Carboplatin

Cisplatin

Antimetabolites

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

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.

Toripalimab

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.

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.

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.

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.

Intensity-modulated radiation therapy

Hui Chang, MD

Yuanhong Gao, MD

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.

This Phase 2 trial uses a single-arm, Simon's two-stage design.

Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation

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

The percentage of the cases attaining cCR of primary tumor and regional lymph nodes (confirmed by radiography and cystoscopy)

The percentage of the cases attaining pCR of primary tumor (confirmed by multipoint biopsy under cystoscopy)

The percentage of the cases surviving over a given time period

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

The percentage of the cases surviving without locoregional recurrence or distant metastasis over a given time period

The percentage of the cases with locoregional recurrence over a given time period

The percentage of the cases with any G3/4 toxicity during the period of treatment

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

The percentage of the cases attaining clinical complete or partial response of primary tumor and regional lymph nodes (confirmed by radiography and cystoscopy)

Sun Yat-sen University

Vice Director of the Department of Radiation Oncology, Cancer Center

Patients receive neoadjuvant CCRT and neoadjuvant CTx. Radical cystectomy is performed depending on pathologic response. The patients showing clinical complete response after neoadjuvant CCRT and initially stage T2N0M0 are not treated with neoadjuvant chemotherapy.

Woong Sub Koom

This study is aimed to develop a genome-based platform to predict patients who can achieve bladder preservation after neoadjuvant treatment. The main treatments for invasive bladder cancer are radical cystectomy and intrapelvic lymph node dissection, but 50% of patients experience recurrence within 2 years after surgery. The recurrence after surgery is associate with T3 stage, the presence of invading soft tissue around the bladder and N1, lymph node metastasis. Therefore, various methods are being tried to reduce recurrence and metastasis, among which preoperative chemotherapy has been reported to increase survival rate. Based on this, preoperative chemotherapy followed by radical cystectomy are also recommended. However, there are several limitations; The surgery may be delayed in case of non-responsive to chemotherapy, the difficulty of tolerance of chemotherapy as the patients are relatively old in bladder cancer. Therefore, the preoperative concurrent chemoradiotherapy can be considered as a treatment effectively lower the recurrence. In several retrospective study has reported that preoperative radiation induces the down-staging and leads to prolonged progression free survival. However, after radical cystectomy, there is discomfort for patients regarding the removal of the bladder. Treating the bladder while preserving the bladder is getting its attention. The representative treatment is performing neoadjuvant concurrent chemotherapy followed by transurethral resection of bladder tumor. The bladder preserving treatment is performed in patients who have unresectable, locally advanced bladder cancer or are not medically appropriate for surgery. The 5-year overall survival is reported to be around 50-60%. To date, no clinical trial has been conducted to compare whether concurrent chemoradiotherapy can achieve the comparable clinical outcome as radical cystectomy in operable conditions. Therefore, in order to perform the bladder preserving treatment, a platform selecting patients who can preserve the bladder from bladder preserving treatment in advance is needed. Responsiveness to radiotherapy is a combination of various factors, and radiation sensitivity of tumors is the most important. The recent study has been demonstrated that physician can predict radiation sensitivity using genomic data. In this study, we intend to develop a platform that can predict responsiveness to radiotherapy and select patients who can preserve bladder using genomic information.

The treatment in this study is one of the standard treatments suggested by the NCCN guidelines. Bladder is preserved when neoadjuvant concurrent chemoradiotherapy is performed after transurethral resection of bladder tumor and complete remission is achieved through the cystoscopy. If complete response is not achieved, additional chemotherapy is performed. In case that complete response is not achieved through the cystoscopy after additional chemotherapy, cystectomy is performed. If complete response is achieved, the bladder is preserved.

Before treatment, the following are obtained; Medical history and physical examination, Tissue acquisition through transurethral resection of bladder tumor, Blood Test (CBC), Chemistry Test (SMA), staging through pelvic CT or MRI, cystoscopy, PET-CT or chest CT.

Cisplatin based concurrent chemoradiotherapy is conducted 4 times during the radiotherapy. AFter radiotherapy, the gemcitabine/cisplatin or gemcitabine/carboplatin treatment is performed. The target delineation is performed in 3mm simulation CT for radiotherapy. To consider the uncertainty of breath, the 4D CT is taken. GTV includes primary lesions and lymph node based on diagnostic CT, MRI, and PET-CT. CTV covers the entire bladder with microscopic margin of GTV. PTV1 is defined as extending 1.5cm from the entire bladder. PTV2 is defined as extending 1.5cm from GTV. Radiotherapy is performed using 3D conformal radiotherapy, intensity-modulated radiotherapy, volumetric modulated Arc therapy. Radiotherapy is administered daily, five times a week according to the NCCN guidelines. Each treatment is performed with bladder empty. radiotherapy is performed 20 fractions in total. For the first 15 fractions, 2.65Gy administered for PTV1 including the entire bladder. For rest 5 fractions, 3 Gy for PTV2 is administered. Totally, 55 Gy is administered.

If complete response is not achieved, the surgery and timing of surgery are determined by the urologist according to the location and severity of the primary cancer. The biopsy if performed using cystoscopy. If the findings are complete response, no additional treatment is performed, and if not, radical cystectomy is performed.

The treatment response is evaluated based on standard treatment process. During the treatment, the regular check up is conducted to evaluate the acute toxicity regarding treatment. After bladder preserving treatment, the pelvic CT, MRI and cystoscopy is used for evaluation.

The acquired specimens are ;used for RNA sequencing and organoid construction. The RNA sequencing is used to analyze the differentially expressed based on treatment response to neoadjuvant concurrent chemoradiotherapy.

RNA sequencing was performed after RNA was isolated from the tissue sample obtained from TURB

a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients

Development of a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation After Preoperative Chemoradiotherapy in Muscle Invasive Bladder Cancer Patients

Research related documents will be stored in a file with a separate password under the responsibility of the lead researcher and stored in a locked laboratory. These research-related records will be kept for 3 years from the time the research is completed, and after that, the research team will discard the documents.

Tissue samples obtained from patients are subjected to genome analysis by extracting RNA and DNA. Patient registration information is encrypted and stored separately, and stored in freezer at -80°C until experimentation at Yonsei University Medical Research Institute under the supervision of the research director.

The rate of patients achieve bladder preservation without radical cystectomy

The rate of lesions detected as pathologically complete response after neoadjuvant treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)	NCT05879653	Bladder Cancer	MK-3475 ASG-22CE maximal TURBT Radiation thera...	18 Years -	Kyoto University Hospital
Durvalumab Plus Tremelimumab With Concurrent Radiotherapy for Localized Muscle Invasive Bladder Cancer Treated With a Selective Bladder Preservation Approach	NCT03702179	Invasive Bladde...	Durvalumab Tremelimumab Radiotherapy	18 Years -	Spanish Oncology Genito-Urinary Group
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation	NCT05975307	Muscle-Invasive... Programmed Cell... Radiotherapy	Toripalimab Gemcitabine Cisplatin Carboplatin Intensity-modul...	18 Years - 75 Years	Sun Yat-sen University
a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients	NCT04686149	Muscle-Invasive...		19 Years -	Yonsei University

Spots Global Cancer Trial Database for bladder preservation