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Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated September 5, 2025 (before its estimated April 2, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites revised (3)v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Nov 20, 2023 to Apr 2, 2024
    • Study sites: 1 to 3
    • Primary completion date: Nov 20, 2025 to Apr 2, 2026
    • Study completion date: Nov 20, 2026 to Apr 2, 2028
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Immunotherapy with programmed death-1(PD-1) inhibitors is now standard therapy for first-line use in patients with driver-negative advanced NSCLC, whether as single-agent or in combination with chemotherapy. After progression of first-line immunotherapy, NSCLC patients may be treated with chemotherapy, radiotherapy or targeted therapies, among others. Recently, Immune Checkpoint inhibitors (ICIs) rechallenge has become a highly anticipated option. Although the objective response rate of the ICIs rechallenge patients has decreased substantially compared with the efficacy of the first ICI treatment, nearly 50% of patients can regain disease control. Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate viable tumour cells in target tissues. It has been reported that ablation can enhance immune response. The objective of this study was to evaluate the efficacy and safety of toripalimab (PD-1) in combination with cryoablation in the treatment of oligometastatic driver-negative advanced NSCLC after first-line immunotherapy progress.
Trial Details
NCT Number NCT06127303
Lead Sponsor Shanghai Chest Hospital
Conditions
(from sponsor)		 Non-small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov