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PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 16, 2024 (before its estimated June 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Secondary endpoints: details revised at 2 of 6 entriesv3
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 28, 2023 to Feb 4, 2024 · Eligibility criteria shortened, about 1 wordv2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 28, 2023 to Feb 4, 2024
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently. On this basis, the investigators intend to conduct a prospective, multicenter phase III clinical trial to assess whether radiotherapy with concurrent chemotherapy and immunotherapy could further improve the survival of patients with metastatic esophageal cancer. Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection (Including Whole Exome Sequencing and proteomics) to explore potential biomarkers for predicting outcomes, efficacy and toxicity.
Trial Details
NCT Number NCT06086457
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators: Peking University Cancer Hospital & Institute, Beijing Cancer Prevention & Treatment Society, Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, Fujian Cancer Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Sichuan Cancer Hospital and Research Institute, Tengzhou Central People's Hospital, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Affiliated Hospital of North Sichuan Medical College, Changzhou Cancer Hospital of Soochow University, Henan Cancer Hospital
Conditions Esophageal Neoplasms
Enrollment 436 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov