NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local UTUC
ConditionUpper Tract Urothelial Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital
About this trial
The NECTAR study is a multicenter, open-label, randomized phase II clinical trial designed to evaluate a neoadjuvant treatment strategy in patients with localized upper tract urothelial carcinoma (UTUC).
In this study, eligible participants will be randomly assigned to receive either neoadjuvant treatment with toripalimab plus the investigational drug 9MW2821 followed by radical nephroureterectomy with or without lymph node dissection, or upfront radical nephroureterectomy with or without lymph node dissection as standard of care. The purpose of the study is to compare the pathologic response at the time of surgery between the two treatment approaches and to assess treatment safety.
Participants will be monitored throughout treatment and follow-up for treatment response, adverse events, and other clinical outcomes. The information obtained from this study may help improve future treatment strategies for patients with localized UTUC.
Eligibility criteria
Qualifiers
Adults aged 18 to 80 years, male or female.
Histologically confirmed upper tract urothelial carcinoma (UTUC) involving the renal pelvis and/or ureter, with predominant (≥50%) urothelial histology.
Treatment-naïve, non-metastatic disease (M0) with clinical stage T1-T3, as determined by imaging.
Eligible for and willing to undergo radical nephroureterectomy with or without lymph node dissection.
Disqualifiers
Prior systemic anti-tumor therapy for urothelial carcinoma, except for intravesical therapy for non-muscle-invasive disease.
Prior treatment with a programmed cell death 1 (PD-1) inhibitor, programmed cell death ligand 1 or 2 (PD-L1/L2) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, or antibody-drug conjugate.
Evidence of metastatic disease (M1) or regional lymph node involvement of N2 or higher.
Prior systemic anticancer therapy, including investigational agents, within 3 years prior to study enrollment.
Trial design
Treatments tested in this trial
- Toripalimab
- 9MW2821
- Radical Nephroureterectomy with or without Lymph Node Dissection
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University Third Hospital
Lead sponsor
Jiangsu Provincial People's Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Beijing Friendship Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Source ClinicalTrials.gov