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A Phase II Clinical Study Based on Endoscopic Laser Ablation Combined with Enfortumab Vedotin and Toripalimab for the Treatment of Localized High-Risk Upper Tract Urothelial Carcinoma

A Phase II Clinical Study Based on Endoscopic Laser Ablation Combined with Enfortumab Vedotin and Toripalimab for the Treatment of Localized High-Risk Upper Tract Urothelial Carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121637
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Tract Urothelial Carcinoma

Interventions

experimental group:Patients received 3 cycles (Q3W) of induction therapy with EV 1.25 mg/kg (D1, D8) plus Toripalimab 240 mg (D1), followed by endoscopic laser ablation/coagulation of the tumor. After

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years and =50%, tumor 2 years; 7. Signed informed consent and agreement to receive treatment and follow-up according to the plan.

Exclusion criteria

Exclusion criteria: 1. Imaging-confirmed >=cT3 stage, or N+, or distant metastasis; 2. Prior systemic anti-tumor therapy or radiotherapy for UTUC; 3. Severe anatomical alterations of the urinary tract or ureteral stricture preventing endoscopic intervention; 4. Contraindications to anesthesia, surgery, or medication, including intolerance to Enfortumab or Toripalimab; 5. Active infection (e.g., HBV, HCV, HIV, tuberculosis) or immunosuppressed state; 6. Autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years; 7. Major cardiovascular or cerebrovascular disease, or severe medical comorbidities compromising safety; 8. Pregnant or lactating women; 9. Active malignancy other than UTUC within the past 5 years (except for skin basal /squamous cell carcinoma, carcinoma in situ of the cervix, etc.).

Design outcomes

Primary

MeasureTime frame
Conversion-Free Survival;

Secondary

MeasureTime frame
Disease free survival;Metastasis free survival;Progression free survival;Renal function retention rate;Clinical complete remission rate;

Countries

China

Contacts

Public ContactBao Yige

West China Hospital of Sichuan University

yige.bao@scu.edu.cn+86 186 0282 1046

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026