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NCT06969534
Safety and Efficacy of Pucotenlimab in pLECC
Phase 2 trial testing Pucotenlimab combined with GP regimen in Lymphoepithelioma-like Carcinoma in 33 participants. Currently enrolling.
30 December 2027
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 15 May 2025 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Pucotenlimab combined with GP regimen — full drug profile →
Conditions studied
- Lymphoepithelioma-like Carcinoma — all drugs for Lymphoepithelioma-like Carcinoma →
- Lymphoepithelioma — all drugs for Lymphoepithelioma →
- Carcinoma — all drugs for Carcinoma →
Sponsor
Sun Yat-sen University
Who can join
Adults 1 to 18, any sex, with Lymphoepithelioma-like Carcinoma or Lymphoepithelioma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lymphoepithelioma-like carcinoma (LELC) in children is a rare epithelial malignant tumor. Regarding pediatric lymphoepithelioma-like carcinoma (pLELC), its clinicopathological features, prognosis, and molecular characteristics remain unknown. In preclinical studies, this study aims to explore the safety and efficacy of the PD-1 monoclonal antibody pucotenlimab combined with the chemotherapy regimen of gemcitabine and cisplatin as the first-line treatment for lymphoepithelioma-like carcinoma in children and adolescents.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06969534
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Sun Yat-sen University trials
Trials by the same sponsor.
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- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · 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 NCT06969534 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
- Last refreshed: 15 May 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/NCT06969534.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing