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NCT04672317
Neoadjuvant PD-1 Monoclonal Antibody Plus Cisplatin-based Chemotherapy in Locally Advanced Upper Tract Urothelial Carcinoma
Phase 2 trial testing Immunotherapy combined with chemotherapy in Neoadjuvant Therapy of Locally Advanced Upper Urinary Tract Urothelial Carcinoma in 20 participants. Status unknown.
1 June 2022
Quick facts
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 10 December 2020 |
| Primary completion | 1 June 2022 |
| Estimated completion | 1 June 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Immunotherapy combined with chemotherapy — full drug profile →
Conditions studied
- Neoadjuvant Therapy of Locally Advanced Upper Urinary Tract Urothelial Carcinoma — all drugs for Neoadjuvant Therapy of Locally Advanced Upper Urinary Tract Urothelial Carcinoma →
Sponsor
RenJi Hospital
Who can join
Adults 18 to 75, any sex, with Neoadjuvant Therapy of Locally Advanced Upper Urinary Tract Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed prospectively to investigate the safety and efficacy of neoadjuvant PD-1 monoclonal antibody combined with cisplatin-based chemotherapy in patients with locally advanced upper urinary tract urothelial carcinoma (UTUC). Tislelizumab, an anti-programmed death protein-1 (PD-1) monoclonal antibody, was engineered to minimize binding to FcγR on macrophages to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. The safety, tolerability, and efficacy of tislelizumab in patients with PD-L1 positive urothelial carcinoma who progressed during/following platinum-containing therapy was proved in a phase 2 trial (CTR20170071). This trial focuses on the efficacy of Tislelizumab in combination with cisplatin-based chemotherapy to induce pathological down-staging of locally advanced UTUC in neoadjuvant setting.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Update on systemic treatment of upper tract urothelial carcinoma: a narrative review of the literature.
Gust KM, Resch I, D'Andrea D, Shariat SF. · · 2021 · cited 12× · PMID 34804847 · DOI 10.21037/tau-21-47 -
Upper Tract Urinary Carcinoma: A Unique Immuno-Molecular Entity and a Clinical Challenge in the Current Therapeutic Scenario.
Mazzaschi G, Giudice GC, Corianò M, Campobasso D, et al · · 2023 · cited 6× · PMID 36855829 · DOI 10.1177/15330338231159753
Verify or expand the search:
- PubMed search for NCT04672317
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Immunotherapy combined with chemotherapy
Trials testing the same drug.
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- NCT07161115 — Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rec · Phase 2 · not yet recruiting
Other RenJi Hospital trials
Trials by the same sponsor.
- NCT07584733 — Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper · Phase 2 · not yet recruiting
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- NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04672317 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RenJi Hospital
- Last refreshed: 17 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04672317.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing