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Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC

Study acronym: TCRTOE
StatusUnknown
PhasePhase 2
Started
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Record status
This record was last updated December 26, 2023 (before its estimated October 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2023); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Study title revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation. Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. Tirelizumab is the first-line and second-line standard treatment for advanced esophageal squamous carcinoma. However, the effect of tirilizumab combined with concurrent chemoradiation for elder with locally advanced esophageal squamous cell carcinoma is unkown. In the study, the investigators plan to enroll 136 elderly subjects with locally advanced esophageal cancer from five hospitals in China. The enrolled patients will be randomly divided into two groups: tirilizumab combined with concurrent chemoradiation group (Tislelizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.
Trial Details
NCT Number NCT06061146
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Collaborators: Sichuan Cancer Hospital and Research Institute, Shanxi Province Cancer Hospital, Henan Cancer Hospital, Hunan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University
Conditions
(from sponsor)		 Esophageal Cancer
Related terms Esophageal Neoplasms
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov