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NCT05628922
Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT
Phase 2 trial testing Toripalimab in Nasopharyngeal Cancer in 198 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 198 |
| Start date | 2 July 2022 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 July 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Toripalimab (TORIPALIMAB) — full drug profile →
- Induction chemotherapy and concurrent chemoradiation
Conditions studied
- Nasopharyngeal Cancer — all drugs for Nasopharyngeal Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 70, any sex, with Nasopharyngeal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Nasopharyngeal carcinoma is biologically different from traditional head and neck squamous cell carcinoma. The mainstay treatment for locally advanced nasopharyngeal carcinoma is cisplatin-based concurrent chemoradiation. Recent phase III randomized control trials have demonstrated that induction chemotherapy plus concurrent chemoradiation further improved progression-free survival. However, not every patient has good response to induction chemotherapy. Evidence has accumulated that those with poor response to induction chemotherapy, or those with detectable Epstein-Barr Virus (EBV) DNA post induction chemotherapy, correlated with poorer progression-free survival. Huang CL et al. (Int J Radiat Oncol Bio Phys. 2019) reported that plasma EBV DNA load at completion of induction chemotherapy was an independent and earlier predictor for progression-free survival and overall survival in locally advanced nasopharyngeal carcinoma. Lv J et al. (Nat Commun. 2019) demonstrated that real-time monitoring of plasma EBV DNA response added prognostic information, and had the potential uitility for risk-adapted treatment intensification in nasopharyngeal carcinoma. Therefore, investigators selects those with poor plasma EBV DNA response during and after induction chemotherapy, and intensifies the treatment with combination of anti-PD-1 antibody, in order to improve progression-free survival in locally advanced nasopharyngeal carcinoma, according to response-adapted strategy.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Viral oncogenesis in cancer: from mechanisms to therapeutics.
Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9 -
Enhancing efficacy and reducing toxicity: Therapeutic optimization in locoregionally advanced nasopharyngeal carcinoma.
Jiang W, Lv JW, Tang LL, Sun Y, et al · · 2024 · cited 15× · PMID 38843843 · DOI 10.1016/j.xcrm.2024.101594 -
Non‑endemic non‑keratinizing nasopharyngeal carcinoma: Long‑term toxicity following chemoradiation.
Jovanovic Ristivojevic J, Jovanovic Korda N, Vujanac V, Nikitovic M, et al · · 2025 · cited 1× · PMID 40247988 · DOI 10.3892/ol.2025.15029 -
Epstein-Barr virus-associated tumors: commonalities in pathogenesis and the tumor immune microenvironment.
Wang X, Hu D, Li R, Liao W, et al · · 2026 · PMID 42112354 · DOI 10.3389/fimmu.2026.1791347
Verify or expand the search:
- PubMed search for NCT05628922
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Toripalimab
Trials testing the same drug.
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- NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
- NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
- NCT07469956 — Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancre · Phase 2 · not yet recruiting
Other recruiting trials for Nasopharyngeal Cancer
Currently open trials in the same condition.
- NCT06749899 — QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma. · Phase 3 · recruiting
- NCT06682442 — Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma · NA · recruiting
- NCT06349889 — Adebrelimab and Chemoradiotherapy in High-risk LANPC · Phase 2 · recruiting
- NCT06414577 — Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma Af · Phase 2 · active not recruiting
- NCT05983432 — Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors · Phase 1 · recruiting
Other Fudan University trials
Trials by the same sponsor.
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- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · 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 NCT05628922 (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 Fudan University
- Last refreshed: 29 November 2022
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/NCT05628922.
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