Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06584435 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer

Study acronym: TUORA
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Dec 31, 2024 to Nov 1, 2025 Primary endpoints: 2 to 1 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 40 to confirmed 100 · 8 morev2 Show 11 more changesShow less
    • Primary endpoints: 2 to 1
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 100
    • Completion date: Mar 3, 2025 to Nov 1, 2027
    • Start date: Oct 1, 2022 to Oct 10, 2022
    • Interventions: Tremelimumab (Drug) to Toripalimab (Drug)
    • Eligibility criteria expanded, about 322 words
    • Secondary endpoints expanded, about 14 words
    • Study description expanded, about 736 words
    • Site details revised
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if the drug toripalimab (an anti-PD-1 antibody) works to prevent cancer recurrence in patients with high-risk renal cell carcinoma after they have had surgery to remove the kidney (nephrectomy). The study will also learn about the safety of toripalimab in this setting.The main questions the study aims to answer are: 1. Does treatment with toripalimab after nephrectomy increase the time patients live without their cancer returning (disease-free survival) compared to what would be expected without this treatment? 2. What medical problems (side effects) do participants have when receiving toripalimab? This is a single-arm study, meaning all participants in the trial will receive the study drug, toripalimab.. Researchers will monitor participants over time to see if the outcomes with toripalizumab are better than what is historically known for similar patients who only had surgery. Participants in this study will: 1. Receive toripalimab by intravenous (IV) infusion once every 3 weeks for up to about one year ( 17 doses). 2. Visit the clinic regularly for check-ups, which will include: Imaging scans (like CT or MRI) of the chest, abdomen, and pelvis every 12 weeks to check for cancer recurrence. Blood and urine tests to monitor safety. Questionnaires about their quality of life and symptoms. Be followed for a long period after treatment ends to track overall survival and long-term health.
Trial Details
NCT Number NCT06584435
Lead Sponsor Tianjin Medical University Second Hospital
Conditions High-risk Renal Cell Carcinoma
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov