Clinical Research Directory

ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG

This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus Calmette-Guérin and have histologically confirmed presence of Carcinoma in situ (CIS) or have primary or recurrent stage Ta and/or T1 papillary tumors following Transurethral resection.

The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer. The main questions it aims to answer are: 1. Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To 2. Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC

This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC).

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.

DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC

The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.

A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

This is a first-in-human, multicenter, Phase 1/1b, 3-part, double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy. In Part 1, the safety, tolerability, and pharmacology of ZH9 IVI will be evaluated in a single ascending dose (SAD) patient cohort. In Part 2, the safety, tolerability, and pharmacology of ZH9 oral prime followed by ZH9 IVI will be evaluated in 2 patient cohorts at the doses and schedule established in Part 1. In Part 3, the safety, pharmacology, and clinical efficacy of ZH9 will be further evaluated in 2 expansion cohorts of patients with recurrent intermediate- and high-risk NMIBC.

A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.

This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.

A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)

This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); cohort II was patients with non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk); cohort III was patients with muscle-invasive bladder cancer (MIBC) to receive neoadjuvant therapy; and cohort IV was patients evaluated for complete response (CR) after standard trimodality therapy (TMT) treatment (i.e. patients with successful bladder preservation). Primary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence/metastasis; Cohort II: MRD score to assess the sensitivity and specificity of tumor recurrence; Cohort III: MRD score to assess the sensitivity and specificity of tumor remnants. Secondary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence subgroup and metastasis subgroup; Cohort II: MRD score to assess the sensitivity and specificity of different grades and stages of recurrent tumors; Cohort III: MRD scores to assess the sensitivity and specificity of different grades and stages of residual tumors.

Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial

To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT.

Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer

Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall. Immediate systemic chemotherapy post-surgery aims to eliminate microlesions promptly and minimize recurrence risk, yet its safety and efficacy require further exploration. This prospective, single-arm study delves into evaluating the efficacy and safety of immediate postoperative systemic chemotherapy in patients with suspected high-risk non-muscle-invasive bladder cancer.

A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer

Bladder cancer is a common malignancy in the urinary system, ranking 11th in cancer incidence in China (3.48/100,000), with male incidence ranking 8th (5.70/100,000). It is classified as non-muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) based on muscle involvement. About 75% of patients are initially diagnosed with NMIBC, with Ta, T1, and Tis stages comprising 70%, 20%, and 10%, respectively. With the advancement of magnetic resonance imaging (MRI), its role in bladder cancer diagnosis and staging has expanded. Multiparametric MRI (MpMRI) enhances staging accuracy with better anatomical visualization. In 2018, Valeria et al. introduced the VI-RADS scoring system, which uses MpMRI to predict tumor stage. Retrospective studies by Wang et al. found that all tumors with a VI-RADS score of 1 were NMIBC, and 95.1% of tumors with a score of 2 were also NMIBC. A VI-RADS score of ≤2 can be used to identify NMIBC with high sensitivity. NMIBC shows varied risks for recurrence and progression based on tumor characteristics like size, stage, grade, and multiplicity. The European Association of Urology (EAU) risk stratification system, established in 2021, classifies NMIBC into low-, intermediate-, high-, and very-high-risk groups. Transurethral resection of bladder tumor (TURBT) is the primary diagnostic and therapeutic approach for most NMIBC cases. However, residual tumors can remain after the first TURBT. For Ta and T1 tumors, 17%-72% and 33%-78% of cases show residual disease during second resection, respectively. Re-staging TURBT for T1 tumors improves prognosis. Studies show that second TURBT offers longer recurrence-free survival (47 months) compared to a single TURBT (12 months). The 5-year progression rate was 6.5% with second TURBT, compared to 23.5% with a single procedure. Following TURBT, floating and residual tumor cells may lead to recurrence. Immediate postoperative bladder instillation of chemotherapy (e.g., pirarubicin, epirubicin, doxorubicin, mitomycin C, gemcitabine) significantly reduces recurrence in low-risk NMIBC but is less effective for intermediate- and high-risk NMIBC. For intermediate-risk NMIBC, maintenance chemotherapy is recommended, and for high-risk NMIBC, BCG immunotherapy is preferred. Both maintenance chemotherapy and BCG instillation reduce recurrence in these groups. Mitomycin C offers comparable efficacy to BCG with fewer side effects. For patients in the very-high-risk group, immediate radical cystectomy is recommended because delayed cystectomy leads to poorer cancer-specific survival. High-risk NMIBC patients may undergo 1-3 years of BCG therapy or immediate cystectomy if necessary. Large-volume NMIBC (≥5 cm) presents significant challenges in treatment. TURBT for large tumors often leads to difficulties in resection due to excessive bleeding, unclear vision, and increased risk of bladder wall injury. Larger tumors also increase the risk of tumor cell seeding and metastasis. Tumor size (≥3 cm) is an independent risk factor for early recurrence and progression, leading some experts to recommend immediate radical cystectomy for large-volume NMIBC. Radical cystectomy is a high-risk procedure with complication rates of 28%-64% and mortality rates of 2.5%-2.7%. It also requires urinary diversion, which can significantly impact a patient's physical, psychological, and social well-being. Patients often face lifelong use of urinary collection devices, reducing their quality of life. Given the impact of radical cystectomy, bladder-sparing strategies have gained attention. These approaches aim to preserve the bladder while controlling tumor growth, maintaining the patient's quality of life. Currently, no formal guidelines exist for bladder-sparing treatment of large-volume NMIBC. However, a 2022 Chinese consensus emphasizes maximal TURBT followed by adjuvant therapy to reduce recurrence and progression. Intravesical chemotherapy, particularly BCG and mitomycin C, is a key part of postoperative management. In the era of immunotherapy, PD-1/PD-L1 inhibitors are emerging as essential components of bladder-sparing strategies. Pembrolizumab, for example, has shown a 41% complete response rate in BCG-unresponsive NMIBC, leading to its FDA approval for carcinoma in situ patients who are ineligible or unwilling to undergo radical cystectomy. Although neoadjuvant chemotherapy is not yet included in NMIBC guidelines, its success in MIBC suggests potential benefit for NMIBC. Neoadjuvant chemotherapy improves survival by 5%-10% and reduces mortality by 16%-33%. After achieving a pathological complete response (pT0), patients can avoid radical cystectomy, with a 5-year survival rate of 90%. This study aims to explore the feasibility of bladder-sparing treatment for large-volume NMIBC, balancing quality of life with oncological outcomes.

A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.

This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+.

SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt

This is a single-center, single-arm, phase Ib/II study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) which is not completely resectable by transurethral resection of bladder tumor (TURBt).

RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects

In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine.