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A Multi Tumor, Open Phase I Clinical Study on the Progression of First-line Anti-tumor Therapy Using Cardonizumab Combined With Pulsed Low-dose Rate External Irradiation (PLDR)

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Phase: Phase 1/2 to Phase 1v2 Show 9 more changesShow less
    • Enrollment target: 33 to 20
    • Primary completion date: Feb 1, 2025 to Jun 30, 2027
    • Start date: Feb 1, 2024 to Sep 1, 2025
    • Primary endpoint revised
    • Study completion date: Feb 1, 2026 to Sep 1, 2027
    • Eligibility criteria expanded, about 494 words
    • Secondary endpoint revised
    • Study title expanded, about 11 words
    • Collaborators expanded, about 3 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
At present, the treatment methods for recurrent cancers are very limited. The immune checkpoint inhibitors (ICBs) is a promising new directions for recurrent lung cancer/ esophageal cancer / cervical cancer, but the clinical response rate is insufficient. Pulse low-dose rate radiotherapy (PLDR) is a new technology in recent years, which uses continuous pulse low-dose rate irradiation to induce hypersensitivity in tumors, and its clinical safety has been verified. Compared to conventional radiotherapy, PLDR has advantages in protecting the lymphatic system and relieving the immune barrier, but it is still unclear whether it can improve the efficacy of ICB. This project aims to combine PLDR with ICB to explore new strategies for recurrent patients.
Trial Details
NCT Number NCT06232083
Lead Sponsor Anhui Provincial Hospital
Collaborators: Akeso Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Lung Cancer, Esophageal Cancer, Cervical Cancer
Related terms Esophageal Neoplasms, Lung Neoplasms, Uterine Cervical Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov