Evaluating the efficacy and safety of bladder-sparing regimen with Disitamab Vedotin combined with Toripalimab and pelvic lymph node dissection in muscle-invasive bladder cancer patients: study protocol of a multicenter single-arm phase II trial

• Published in: BMC cancer Vol. 25; no. 1; pp. 868 - 8
• Main Authors: Lan, Tianhang, Zhu, Yingying, Zhong, Wenlong, Tan, Qihong, Lin, Tianxin, Huang, Jian, He, Wang
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 13.05.2025; BioMed Central; BMC
• Subjects: Adult; Aged; Antibodies; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Apoptosis; Arm; Biological products; Bladder cancer; Bladder-sparing treatment; Cancer; Cancer patients; Cancer therapies; Care and treatment; Cell death; Cellular biology; Clinical trials; Clinical Trials, Phase II as Topic; Combination therapy; Combined Modality Therapy; Cystectomy; Disitamab Vedotin; Ethics; Female; Health aspects; Humans; Immune checkpoint inhibitors; Immunoconjugates - administration & dosage; Invasiveness; Lymph Node Excision - methods; Lymph nodes; Lymphatic system; Male; Malignancy; Medical prognosis; Metastases; Metastasis; Middle Aged; Multicenter Studies as Topic; Muscle-invasive bladder cancer (MIBC); Neoplasm Invasiveness; Oligopeptides; Oncology, Experimental; Organ Sparing Treatments - methods; Patient outcomes; Patients; Pelvic lymph node dissection (PLND); Pelvis; Preservation; Product development; Quality of life; Radiation therapy; Study Protocol; Surgery; Survival; Toripalimab; Toxicity; Transurethral bladder tumor resection (TURBT); Treatment Outcome; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - pathology; Urinary Bladder Neoplasms - therapy; Urological surgery; Viral antibodies; Vital signs; China; Transurethral bladder tumor resection (TURBT); Disitamab Vedotin; Muscle-invasive bladder cancer (MIBC); Toripalimab; Bladder-sparing treatment; Pelvic lymph node dissection (PLND)

Muscle invasive bladder cancer (MIBC) is a malignancy with high recurrence and metastasis rate. Radical cystectomy and lymph node dissection are the current standard cares for MIBC. The demand for bladder preservation in MIBC patients is growing daily; however, the recognized trimodal bladder-sparin...