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NCT06127303
Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC
Phase 2 trial testing Toripalimab in Non-small Cell Lung Cancer in 54 participants. Currently enrolling.
2 April 2026
Quick facts
| Lead sponsor | Shanghai Chest Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 2 April 2024 |
| Primary completion | 2 April 2026 |
| Estimated completion | 2 April 2028 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Toripalimab (TORIPALIMAB) — full drug profile →
- Cryoablation — full drug profile →
Conditions studied
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
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):
-
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 -
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 -
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:
- PubMed search for NCT06127303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Non-small Cell Lung Cancer
Currently open trials in the same condition.
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Other Shanghai Chest Hospital trials
Trials by the same sponsor.
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- NCT07528066 — Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC · recruiting
- NCT07331727 — Epicardial Adipose Tissue-Targeted DApagliflozin for Reducing Electrical Remodeling in Atrial Fibrillation · NA · not yet recruiting
- NCT07320768 — Renal Denervation Combined With Pulsed Field Ablation to Prevent Blanking-Period Recurrence in Persistent Atrial Fibrill · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06127303 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Chest Hospital
- Last refreshed: 5 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06127303.
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