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NCT06127303

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

Recruiting now Phase 2 Last updated 5 September 2025
What this trial tests

Phase 2 trial testing Toripalimab in Non-small Cell Lung Cancer in 54 participants. Currently enrolling.

Timeline
2 April 2024
Primary endpoint
2 April 2026
2 April 2028

Quick facts

Lead sponsorShanghai Chest Hospital
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment54
Start date2 April 2024
Primary completion2 April 2026
Estimated completion2 April 2028
Sites3 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Chest Hospital

Who can join

Adults 18 to 75, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Consensus on the lung cancer management after third-generation EGFR-TKI resistance.
    Zhou Q, Zhao H, Lu S, Cheng Y, et al · · 2024 · cited 14× · PMID 39759798 · DOI 10.1016/j.lanwpc.2024.101260
  2. Efficacy of NSCLC Rechallenge with Immune Checkpoint Inhibitors following Disease Progression or Relapse.
    Livanou ME, Nikolaidou V, Skouras V, Fiste O, et al · · 2024 · cited 13× · PMID 38539530 · DOI 10.3390/cancers16061196
  3. Research status and trend of lung cancer ablation therapy: a bibliometric analysis from 2002 to 2025.
    Zou Q, Qi D, Huang X, Zhang Z, et al · · 2026 · PMID 41822233 · DOI 10.21037/jtd-2025-aw-2172

Verify or expand the search:

Other trials of Toripalimab

Trials testing the same drug.

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

Other Shanghai Chest Hospital trials

Trials by the same sponsor.

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Data sources for this page

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