Nearly all undifferentiated nasopharyngeal carcinoma (NPC) are associated with the Epstein-Barr Virus (EBV), which typically remains in a latent, non-immunogenic state within tumor cells. By combining EBV lytic induction strategy with standard chemo-immunotherapy, this study aims to create a synergistic anti-tumor effect and improve clinical outcomes for patients with recurrent/metastatic NPC (r/m NPC). This is a phase II, single-center, single-arm clinical trial designed to evaluate the efficacy and safety of a novel combination therapy in patients with r/m EBV-positive NPC.
Patients must voluntarily participate and provide written informed consent.
Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) at enrollment, with positive EBERs by pathological immunohistochemistry.
Metastatic NPC includes both newly diagnosed metastatic disease and metastatic disease after failure of first-line therapy, as well as recurrent NPC not amenable to local regional treatment, with confirmed metastatic or recurrent disease and no prior treatment after diagnosis.
Age ≥ 18 years and ≤ 75 years, of any sex.
History of severe hypersensitivity reactions to other monoclonal antibodies or to any component of PD-1 inhibitors.
Receipt of radiotherapy, biological therapy (e.g., tumor vaccines, cytokines, or growth factors), or other immunotherapy (excluding PD-1 and PD-L1 inhibitors), or any other anti-tumor treatment within 28 days or 5 half-lives prior to the first dose of study drug, whichever is shorter.
Prior treatment targeting Epstein-Barr virus (EBV) specifically.
History of any Grade ≥3 bleeding event, as defined by CTCAE v5.0, within 4 weeks prior to screening, or patients deemed at high risk of bleeding by the investigator.
Single group
Valganciclovir Hydrochloride Tablets
DrugValganciclovir hydrochloride tablets will be administered at 900 mg twice daily from day 1 to day 14, followed by 450 mg twice daily from day 15 to day 20, for a total of 3 cycles.
gemcitabine, cisplatin, and PD-1 antibody
DrugGemcitabine 1000 mg/m² will be administered intravenously on days 1 and 8; cisplatin 80 mg/m² intravenously on day 1; and PD-1 antibody intravenously on day 1. Each cycle is 21 days in duration, and treatment will be administered for a total of 4 to 6 cycles. Following completion of the 4 to 6 cycles, patients will continue PD-1 antibody maintenance therapy (every 3 weeks) for up to two years or until disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of informed consent, or death.
Objective Response Rate, ORR
Objective Response Rate (ORR) is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 from the National Cancer Institute (NCI).
Disease Control Rate，DCR
Disease Control Rate (DCR) is defined as the proportion of patients who achieve tumor response classified as partial response (PR), complete response (CR), or stable disease (SD) according to recognized response evaluation criteria-such as RECIST version 1.1.
Progression-free Survival, PFS
Defined as the time from registration to documented disease progression or non-cancer-specific death.
Duration of Response, DoR
Defined as the median length of time from the initial documentation of a tumor response (either complete response \[CR\] or partial response \[PR\]) to disease progression or death from any cause.
Overall Survival, OS
Defined as the time from registration to death from any cause.
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Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution
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