RecruitingPhase 2NCT05628922

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

Sponsor

Fudan University

Enrollment

198 participants

Start Date

Jul 2, 2022

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adjusting the intensity of treatment based on a blood marker (EBV DNA, a virus-linked signal) after initial chemotherapy improves outcomes for people with locally advanced nasopharyngeal carcinoma — a cancer at the back of the nasal cavity. The idea is to give less toxic treatment to patients with a good early response, and more intensive treatment to those with a poor response. **You may be eligible if...** - You are 18–70 years old with a new diagnosis of locally advanced nasopharyngeal carcinoma confirmed by biopsy (non-keratinizing type) - Your cancer is staged T3-T4 or has spread to multiple lymph nodes but not to distant organs - Your EBV DNA blood level is detectable before treatment - You have not received any prior treatment for this cancer - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have the keratinizing or basaloid type of nasopharyngeal cancer - Your EBV DNA is undetectable before treatment starts - You have had prior radiation therapy that would overlap with this treatment field - You have another current malignancy (minor exceptions apply) - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

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.

OTHERInduction chemotherapy and concurrent chemoradiation

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.