Combination treatment for HER2-positive upper tract urothelial carcinoma after surgery

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)

This study is testing a new combination of targeted therapy and immune treatment to see if it helps prevent cancer from coming back in patients with HER2-positive upper tract urothelial carcinoma after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05917158 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of RC48-ADC, a targeted therapy, combined with JS001, an immune checkpoint inhibitor, for patients with HER2-positive upper tract urothelial carcinoma following radical nephroureterectomy. It is an open-label, single-arm study where participants will receive these treatments as postoperative adjuvant therapy. The trial aims to determine how well this combination works in preventing cancer recurrence in eligible patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone radical nephroureterectomy for HER2-positive upper tract urothelial carcinoma.

Not a fit: Patients with distant metastases or those with pure adenocarcinoma or other variant histologies will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with HER2-positive upper tract urothelial carcinoma after surgery.

How similar studies have performed: While this approach combines established therapies, the specific combination of RC48-ADC and JS001 in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Nanjing, Jiangsu

• Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Le Qu, M.D.

Conditions Carcinoma; Upper Tract Urothelial Carcinoma; UTUC