Aún no reclutaNCT07927400Registro de ClinicalTrials.gov

An Exploratory Study of the Efficacy and Safety of SBRT Following Induction Therapy With Neoadjuvant Immunotherapy Combined With Chemotherapy in Muscle-Invasive Bladder Cancer

Muscle-invasive Bladder Cancer

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - 85 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 36 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This study aims to systematically evaluate the efficacy and safety of this innovative comprehensive treatment model in patients with MIBC. By prospectively observing the clinical complete remission rate, bladder recurrence-free survival period, overall survival period, as well as the incidence and severity of treatment-related adverse events, investigators hope to clarify the clinical effectiveness of this model and provide a potential new and efficient bladder-preserving approach for MIBC. Comprehensive assessment of its safety profile will provide a basis for patient management and risk control in clinical practice. Exploration of potential biomarkers (such as PD-L1 expression, tumor mutation burden, etc.) is expected to enable precise selection of treatment options in the future. The successful implementation of this study is expected to bring significant changes to the treatment paradigm for MIBC, achieving the best oncological outcomes while maximizing the preservation of patient organ function and quality of life, and having significant social benefits and clinical promotion value.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Those who voluntarily sign the informed consent form, understand the nature, purpose and procedures of this trial and voluntarily comply with the trial requirements;
Male or female, aged between 18 and 85 years;
Patients with pathologically confirmed MIBC;
Those who meet the new adjuvant treatment criteria for MIBC and have not undergone tumor-related treatment before;
Patients with clinical tumor stage of cT2-T4aN0M0;
Male participants or potentially pregnant females must use highly fertile males or potentially pregnant females during the trial, must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, inhibitory methods or contraceptive methods combined with spermicides) during the test, must use contraceptive methods combined with spermicides at the end of the treatment, and use contraception for 12 months after the treatment;
The main organ functions simultaneously meet the following standards: 1) Absolute neutrophil count ≥ 1.5 × 109/L; 2) Platelets ≥ 90 × 109/L; 3) Hemoglobin ≥ 90 g/L; 4) Serum creatinine ≤ 1.5 times the upper limit of normal (ULN); 5) Serum total bilirubin ≤ 1.5 times ULN (except for those with Gilbert syndrome); 6) Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 1.5 times ULN; 7) International normalized ratio (INR), activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
People who have the intention to preserve their bladder.

Exclusion Criteria:

Pregnant or lactating women, as well as women who wish to conceive (pelvic radiotherapy may cause premature aging of the ovaries);
Patients with stage IV bladder cancer with distant metastasis;
Those with a history of primary malignant tumors in other parts;
Those with severe organ dysfunction, such as recent cerebrovascular disease, or with diseases or factors that can cause cerebral edema or intracranial hypertension; severe heart diseases or discomfort, including but not limited to the following diseases/factors: 1) Currently suffering from untreated or uncontrollable hypertension (systolic pressure \> 180 mmHg and/or diastolic pressure \> 100 mmHg) or unstable angina pectoris; 2) According to the New York Heart Association (NYHA) classification standard, currently having a history of any level of congestive heart failure or severe need for treatment of arrhythmia (except for atrial fibrillation or paroxysmal supraventricular tachycardia); 3) History of myocardial infarction within the previous 6 months; 4) Patients with pacemakers; significantly reduced liver function or liver reserve function, active liver disease; severe renal parenchymal or renal vascular lesions, renal insufficiency; severe respiratory dysfunction; uncorrected moderate-to-severe anemia; obvious bleeding tendency or DIC tendency;
Subjects with a known history of mental illness, poor compliance;
Those who cannot tolerate neoadjuvant chemotherapy or immunotherapy, radiotherapy;
Women of childbearing age, who do not agree to take one or more effective contraceptive measures during the treatment period and at least 6 months after the last study treatment; with a positive blood pregnancy test;
Those considered by the investigators to be unsuitable for enrollment or may not be able to complete this trial for other reasons;
Other situations that the review personnel from the registration study consider to be unqualified based on the registration: such as potential situations inconsistent with the clinical protocol.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No aplica
Enmascaramiento: Sin enmascaramiento

Experimental group

Maximal TURBT; Induction therapy: Suliimab combined with gemcitabine and cisplatin/oral carboplatin, for a total of 2 cycles; Concurrent chemoradiotherapy (after completing 2 cycles of induction therapy); One course of SBRT radiotherapy: 25Gy/5Gy/5f for the tumor area/tumor bed of the primary bladder lesion; Two courses of external beam radiotherapy: Bladder radiotherapy (45Gy/1.8Gy/25F); Cystoscopy TURBT; Maintenance therapy.

Drug: Suruilimab immunotherapy

Suruilimab immunotherapy DRUG

Test Drug: Suliimun Antibody Injection

1\. Drug Introduction and Special Mechanism Generic Name: Suliimun Antibody Injection Trade Name: Hanszhuang® Category: Recombinant Anti-PD-1 Humanized Monoclonal Antibody Special Mechanism: Suliimun is an immune checkpoint inhibitor. PD-1, as a cell surface receptor, is an important immunosuppressive molecule that regulates T cell function. PD-L1 (and other) ligands are expressed on antigen-presenting cells, tumor cells, or other cells in the tumor microenvironment. The binding of PD-1 to PD-L1 can inhibit T cell proliferation and the secretion of related cytokines. This product is a new injectable recombinant humanized anti-PD-1 monoclonal antibody. By blocking the binding of PD-1 to PD-L1, it enhances the immune response of T cells against tumors, thereby exerting anti-tumor effects.

Role in This Study: In this trial, Suliimun was used as the core component of neoadjuvant immunotherapy, combined with gemcitabine and cisplatin chemotherapy, aimin

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Clinical complete remission (cCR)

Plazo: 3year

1\) The bladder biopsy (including all visible abnormal areas and any additional TURBT or biopsy performed for known muscle-invasive cancer lesions before neoadjuvant therapy) did not reveal any high-grade malignant tumors (i.e., no pTa/pT1/pTis); 2) The urine cytology examination did not detect any malignant cells; 3) The cross-sectional imaging examination provided no clear evidence of local or metastatic diseases.

Bladder event-free survival (BI-EFS)

Plazo: 3year

It is defined as the time period from the initiation of the treatment plan to the recurrence of muscle-invasive bladder cancer (MIBC), regional pelvic recurrence, distant metastasis, bladder cancer-related death, or bladder resection.