A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma

Официальное название

An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined with JS001 in Postoperative Adjuvant Treatment of HER2-positive Upper Tract Urothelial Carcinoma (UTUC)

Обзор

This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.

Подробное описание

This is an open-label, single-arm clinical trial to evaluate the efficacy and safety of RC48-ADC, a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in combination with JS001, a PD-1 monoclonal antibody, for the postoperative adjuvant treatment of HER2-positive upper tract urothelial carcinoma after radical nephroureterectomy.

Вмешательства

• Препарат RC48-ADC and JS001
  Patients in group will receive 6 x 3 week cycles of RC48-ADC (Disitamab Vedotin) 2mg/kg in combination with JS001 (Toripalimab) 3mg/kg intravenously, followed by toripalimab (3 mg/kg) every 3 weeks for up to 1 year.

Первичные конечные точки

• Disease-free survival (DFS) [Срок оценки: 5 years]

Вторичные конечные точки (2)

• Overall survival (OS) [Срок оценки: Patients followed-up for 5 years]
• Metastasis free survival (MFS) [Срок оценки: Patients are followed up for 5 years]

Критерии участия

Критерии включения

• Written informed consent
• ≥18 years of age
• Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC/SCC is permitted.
• Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 (providing all grossly abnormal nodes are resected).
• Pathological tissue immunohistochemistry HER2 2\~3+
• Fit and willing to receive adjuvant therapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
• ECOG(Eastern Cooperative Oncology Group) performance is 0\~2.
• Available for long-term follow-up

Критерии исключения

• Evidence of distant metastases
• Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
• Un-resected macroscopic nodal disease
• Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
• Significant co-morbid conditions that would interfere with administration of protocol treatment
• Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
• Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Chin — Нанкин

Идентификаторы

NCT: NCT05917158 · 2022DZKY-106-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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