View clinical trials related to Muscle Invasive Bladder Cancer.
Filter by:Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection.
Accurate preoperative detection of muscle-invasive bladder cancer remains a clinical challenge. The investigators aimed to develop and validate a knowledge-guided causal diagnostic network for the detection of muscle-invasive bladder cancer with multiparametric magnetic resonance imaging(MRI).
This is a prospective, open, single-center clinical study of RC48 combined with PD-1 and radiotherapy as bladder-preserving therapy in patients with muscular invasive bladder uroepithelial carcinoma with high HER-2 expression (IHC 2+ or 3+). The study was conducted in accordance with the Good Practice for Clinical Trials of Pharmaceutical Products (GCP). Six patients were enrolled in this study. Each patient received RC48 injection [2.0 mg/kg, Q2W, iv] and Toripalimab injection [3mg/kg, Q2W, iv] for 1~2 cycles, and radiotherapy at the second or third cycle. The total dose of bladder irradiation field was greater than 50Gy (about 30 times), and the safety monitoring of the subjects was conducted within 28 days after receiving the study drug treatment for the first time. Adverse events were graded using the National Cancer Institute (NCI) Standard for the Assessment of Common Terminology for Adverse Events (CTCAE) Version 5.0 guidelines, and the occurrence of DLT in patients was observed. If the subject does not complete the safety assessment for the tolerance observation period for non-dose tolerance reasons, a new subject will be replaced.
A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder cancer (high-risk non-muscle invasive and localized muscle-invasive) treated with standard therapies in national cancer treatment reference centers within the last 6 years (between 2017 and 2022).
Through our study, we aim to understand the most important factors for patients when they decide on the type of treatment they receive for MIBC. Our study consists of a discrete choice experiment (DCE): a type of questionnaire used to elicit preferences in the absence of data. DCEs are frequently used in oncological research to elicit preferences from participants without directly asking them to state their preferred options. Participants undertaking our DCE questionnaire will presented with a series of alternative hypothetical scenarios containing several variables or "attributes" (5), each of which may have a number of variations or "levels".
A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer. The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC). Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system. In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.
This trial is designed to evaluate the safety, efficacy, and biomarker response of APL-1202 in combination with tislelizumab as neoadjuvant therapy for patients with MIBC who are cisplatin ineligible or refuse cisplatin-based chemotherapy.
The most frequent cancer of the urinary tract is the bladder cancer (BC), in Italy its incidence reaches the 7% of all the new diagnosis of cancer, accounting for the fifth cause of death in the western countries, overall 140.000 new cases per year in Europe. In the year 2017, the Italian association for medical oncology (AIOM) recorded in our country about 21.700 new diagnosis of BC men and 5.300 in women. This data show not only a relevant gender disparity on the disease incidence (in 5th to 7th decade male incidence: 11-12% of all new diagnosis of cancer versus 1% in women) but also on the outcomes of treatment. Overall, the 30% of all the new diagnosis have a muscle-invasive (MIBC) onset, the female gender suffer a correlation with a more advanced disease at the time of first diagnosis. As a consequence, men have lower BC-related mortality when compared to women (p<0,001). This discrepancy in the mortality rate has been investigated by many authors, resulting in the evidence that female gender suffers higher risks, especially during the first two-years after the radical cystectomy. A comprehensive explanation has not been formulated yet, but a multiplicity of cofactors, including variations in the hormone receptors and tumor biology as well as the different anatomy between male and female, have been identified as potentially relevant. Another important issue in the pre-operatory management of female patients with BC is the misleading interpretation of hematuria. It seems to directly correlate with the evidence that women suffer a more advanced stage at diagnosis, and this element has been withheld in the list of relevant risk factors for prognosis. Nevertheless, a thorough analysis of their effect will only be possible in the future, as well-designed prospective and randomized clinical trials are currently not available. A part from the preoperatory disparity, it has also been described that men are more frequently candidates to an orthotopic urinary diversion, leading female patients to an irreversibly altered perception of personal integrity and body image, namely to a lower quality of life after radical cystectomy. The female anatomy has been considered as a limitation to continence recovery, resulting in preoperative counselling more frequently against in favor of ileal conduit or not-continent urinary diversions.
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.
Despite primary surgical management of muscle invasive bladder cancer (MIBC) with radical cystectomy and pelvic lymphnode dissection, up to 50% of patients will eventually develop tumours at distant sites, owing to pre-existing disseminated occult micrometastases. The first line treatment for relapse or metastatic MIBC is gemcitabine and cisplatin. After the failure of first line treatment, second line chemotherapy drugs can be chosen from doxorubicin, docetaxel, pemetrexed, etc. This non-randomized, prospective study aims to explore the efficacy and safety of PEGylated liposomal doxorubicin and PD-1 in second line treatment of MIBC.