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NCT05628922

Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT

Recruiting now Phase 2 Last updated 29 November 2022
What this trial tests

Phase 2 trial testing Toripalimab in Nasopharyngeal Cancer in 198 participants. Currently enrolling.

Timeline
2 July 2022
Primary endpoint
1 July 2026
1 July 2027

Quick facts

Lead sponsorFudan University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment198
Start date2 July 2022
Primary completion1 July 2026
Estimated completion1 July 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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:

Other trials of Toripalimab

Trials testing the same drug.

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Other Fudan University trials

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