RecruitingPhase 2NCT05531123

Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer

A Prospective Phase II Study of Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer After Chemotherapy Combined With PD-1 Antibody(Rebirth)


Sponsor

Fudan University

Enrollment

30 participants

Start Date

Sep 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Neoadjuvant chemotherapy plus radical cystectomy is the standard if care for cisplatin-eligible patients with MIBC. Developments in the last two decades suggest that bladder sparing therapy may be a valuable alternative to radical cystectomy. Currently, well-documented TMT regimens, which include complete transurethral resection of bladder tumor (TURBT), chemotherapy, and radiation therapy, demonstrated durable oncologic control and long-term survival in selected patients. Nevertheless, TMT has not been widely used in clinical practice. On the one hand, due to the complexity of TMT, multiple clinical departments are required to cooperate in the assessment, treatment and follow-up of patients. On the other hand, concerns about tumor recurrence, lack of surgical intervention in regional lymph nodes, and organ dysfunction due to the treatment of large doses of pelvic radiation have reduced the clinical acceptance of TMT. In recent years, immunocheckpoint inhibitors such as PD-1/L1, including Nivolumab, Pembrolizumab, and Tislelizumab, have proven to be promising immunotherapy approaches for advanced urothelium cancer, leading to breakthroughs in the treatment of advanced urothelium cancer. Immunocheckpoint inhibitors also showed positive efficacy in patients who did not respond to BCG treatment during perioperative period. Therefore, immunotherapy can be another means of bladder preservation after surgery, chemotherapy and radiotherapy. However, bladder sparing target population is still unclear, among which, the NCCN guidelines recommend patients suitable for bladder preservation: T2-3N0M0, single lesion (longest diameter less than 6 cm), histological type of urothelial carcinoma, no CIS, and no hydronephrosis. Therefore, the focus of bladder preservation treatment is not only on the treatment before and during bladder preservation, but also on maximizing the follow-up treatment of TURBT and exploring its long-term benefits based on response to systematic treatment before maximized TURBT.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a risk-adapted approach to preserving the bladder in people with muscle-invasive bladder cancer — meaning patients receive treatments tailored to their individual risk level rather than automatically having their bladder removed. **You may be eligible if...** - You are 18–85 years old with muscle-invasive bladder urothelial carcinoma (stages T2–T4a, N0–N1, M0) - You want to keep your bladder and avoid surgery - You have undergone a thorough TURBT (transurethral tumor removal) procedure - You are in reasonably good health (ECOG 0–2) with adequate blood, liver, and kidney function - You are willing to use effective contraception if applicable **You may NOT be eligible if...** - You do not want to pursue bladder-preserving treatment - Your organ function is inadequate for the planned therapies - You have widespread (diffuse) carcinoma in situ or cancer that has spread to distant organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

Tislelizumab 200 mg I.V. Q3W on the day 1

DRUGgemcitabine and cisplatin

Cisplatin 70mg/m2 I.V. Q3W on the day 1, dose fractionation is allowed ;Gemcitabine 1000mg/m2 I.V. Q3W on the day 1 and day 8

RADIATIONModified hypofractionation

* Whole bladder 44Gy / 16fractionation (If N1: Whole bladder + Pelvic nodes 44Gy / 16fractionation) (Positive lymph nodes can be dosed to the maximum tolerable dose) * Tumor boost 11Gy / 4fractionation * Radiosensitizing chemotherapy: DDP 75-80 mg/m2 weekly Q3W


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT05531123


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