GEP Combined With Radiotherapy in Non-locally Treatable Recurrent NPC

Eligible patients will undergo screening before enrolling in this trial 。 The participants will receive R-GEP therapy according to specified dosing schedules over six cycles. Additionally administered low-dose radiotherapy during specific cycles serves to modulate immune microenvironment while high-dose fractionated radiotherapy follows completion of GEP therapy courses. Maintenance immunotherapy continues up until one year post-treatment conclusion or disease progression.Finally, the participants were evaluated accordingly。

Inclusion criteria

• Patients aged ≥18 years;
• ECOG performance status 0-2;
• Pathological or clinical imaging diagnosis of recurrent nasopharyngeal carcinoma;
• With imaging assessable lesions (assessed by RECIST 1.1 criteria);
• Recurrent lesions are not eligible for curative local treatment (including but not limited to extensive invasion of recurrent lesions; recurrent lesions with obvious necrosis or ulceration, with bleeding risk; recurrent lesions extensively invading surrounding nerves/vessels or skin/muscle; obvious late radiation therapy complications after previous treatment: radiation-induced brain injury, posterior cranial nerve injury, dysphagia, severe myofibrosis; second or multiple courses of radiation therapy after recurrence or multiple recurrences);
• The following requirements must be met for the function of major organs:

Hematological parameters tolerable to treatment: white blood cells ≥3.0×10^9/L, neutrophils ≥1.5×10^9/L, hemoglobin ≥9 g/dL, platelets ≥90×10^9/L.

Liver and kidney function: ALT, AST <1.5 times the upper limit of normal (ULN), total bilirubin <1.5×ULN, serum creatinine (Cr) ≤1.5×ULN; Echocardiographic assessment, left ventricular EF ≥50%;

• The patient has signed an informed consent form and is willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other research procedures.
• Voluntarily enroll in this study, sign an informed consent form, have good compliance and willingness to cooperate with follow-up.

Exclusion criteria

• Subjects who cannot accept or tolerate chemotherapy or radiotherapy for various reasons;
• Subjects who can be cured by definitive radiotherapy or surgery;
• Subjects who have undergone major surgical procedures within the past 4 weeks or have not fully recovered from such procedures;
• Subjects who are currently participating in other drug clinical trials;
• Serious cardiac disease or discomfort, including but not limited to the following conditions:

• History of congestive heart failure or impaired systolic function (LVEF <50%);
• Uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate >100bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular conduction block (i.e., Mobitz Ⅱ second-degree atrioventricular conduction block or third-degree atrioventricular conduction block);
• Angina requiring anti-angina drug therapy;
• Clinically significant valvular heart disease;
• ECG showing a penetrating myocardial infarction;
• Uncontrolled hypertension (systolic blood pressure >180mmHg and/or diastolic blood pressure >100mmHg);
• Subjects who have a history of hypersensitivity to any component of the study drug;
• Any other situation in which the investigator deems the subject unsuitable to participate in the study.