NCT07412171Not yet recruitingPhase 2
NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local UTUC
NECTAR Study: A Multicenter, Open-label, Randomized Phase II Study of Neoadjuvant Toripalimab Plus 9MW2821 Versus Upfront Radical Nephroureterectomy With/Without Lymph Node Dissection in Patients With Local Upper Tract Urothelial Carcinoma (UTUC)
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Peking University Third Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07412171
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Feb 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic anti-tumor therapy for urothelial carcinoma, except for intravesical therapy for non-muscle-invasive disease.
- Prior systemic anticancer therapy, including investigational agents, within 3 years prior to study enrollment.
- Prior radiotherapy to the bladder or upper urinary tract.
- Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment.
Other illness
- Evidence of metastatic disease (M1) or regional lymph node involvement of N2 or higher.
- Active autoimmune disease requiring systemic treatment.
- Active or uncontrolled infection, including known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) infection, or active tuberculosis.
- History of allogeneic tissue or solid organ transplantation.
- Clinically significant cardiovascular disease or thromboembolic events that, in the investigator's judgment, would increase study risk.
- Known psychiatric disorder or substance abuse that would interfere with study participation or compliance.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
Lab values
- 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.
- Uncontrolled diabetes mellitus, defined as hemoglobin A1c ≥8%, or hemoglobin A1c ≥7% to \<8% with associated diabetes-related symptoms.
Other
- Ongoing peripheral sensory or motor neuropathy of Grade 2 or higher.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, renal, and cardiac function as defined by the protocol.
- Availability of tumor tissue for biomarker analyses.
- Ability to understand and willingness to sign a written informed consent document.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.