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those with undetectable plasma EBV DNA after first cycle of induction chemotherapy (GP regimen)

those with detectable plasma EBV DNA after first cycle of induction chemotherapy (GP regimen), and undetectable plasma EBV DNA at completion of induction chemotherapy

those with detectable plasma EBV DNA after first cycle and at completion of induction chemotherapy (GP regimen)

Early Responders: They receive the second and third cycle of induction chemotherapy (GP regimen), followed by cisplatin-based concurrent chemoradiation.

Intermediate Responders: they received the second and third cycle of induction chemotherapy (GP regimen) with combination of toripalimap (240mg d1, q3w \* 2 cycles), followed by cisplatin-based concurrent chemoradiation.

Late responders: they received the second and third cycle of induction chemotherapy (GP regimen) with combination of toripalimap (240mg d1, q3w \* 2 cycles), followed by cisplatin-based concurrent chemoradiation. At 4-6 weeks post-chemoradiation, they received adjuvant capecitabine and toripalimab for 6 months.

Toripalimab

Induction chemotherapy (GP regimen) and cisplatin-based concurrent chemoradiation.

GP regimen: Gemcitabine 1.0 g d1,d8, cisplatin 25mg/m2 d1-3 q3w Cisplatin based chemotherapy: cisplatin 80mg/m2 given in three consecutive days, q3w \* 2 cycles.

Induction chemotherapy and concurrent chemoradiation

Chao-su Hu, M.D.

Xiaomin Ou, M.D.

Chaosu Hu, M.D.

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.

In this study, investigators enroll patients with locally advanced nasopharyngeal carcinoma. All the patients recieve GP-based induction chemotherapy. After one cycle of induction chemotherapy, plasma EBV DNA and head and neck MR are performed.

Based on clinical efficacy and changes of plasma EBV DNA, patients with good response will directly receive concurrent chemoradiation (CCRT). Patients with intermediate response will be randomized to immunotherapy group (GP combined with toripalimab for two additional cycles then CCRT) and standard group (GP for two additional cycles then CCRT). Patients with poor response will be switched to TP regimen combined with toripalimab, followed by CCRT. The main endpoint is 2 year progression-free survival rate.

The aim of this study is to clarify whether response-adapted strategy based on clinical efficacy and EBV DNA response confers survival benefit to patients with locally advanced nasopharyngeal carcinoma.

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

Response-adapted Modulation Therapy for Locally Advanced Nasopharyngeal Carcinoma Based on Circulating Epstein-Barr Virus DNA Level Post Induction Chemotherapy

the time from the date of enrollment to progression of disease

the time from the date of enrollment to death

the time from date of enrollment to locoregional recurrence

the time from date of enrollment to distant metastasis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT	NCT05628922	Nasopharyngeal ...	Toripalimab Induction chemo...	18 Years - 70 Years	Fudan University
Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT	NCT05628922	Nasopharyngeal ...	Toripalimab Induction chemo...	18 Years - 70 Years	Fudan University

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