NCT05917158 A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
| NCT ID | NCT05917158 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jinling Hospital, China |
| Condition | Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-11-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2022-11-23 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05917158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05917158 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05917158 currently recruiting?
Yes, NCT05917158 is actively recruiting participants. Contact the research team at septsoul@hotmail.com for enrollment information.
Where is the NCT05917158 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05917158 clinical trial?
NCT05917158 is sponsored by Jinling Hospital, China. The trial plans to enroll 30 participants.