Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma

Inclusion criteria

• The age at the time of diagnosis is 18-75 years old, regardless of gender;
• Histologically confirmed nasopharyngeal carcinoma;
• Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ;
• After receiving standard treatment for 4-6 cycles, the disease is control;
• ECOG score 0-1;
• Expected survival time of at least 12 weeks;
• Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ;
• According to RECIST 1.1 standard, at least 1 measurable lesion;
• Enough organ function;
• Sign an informed consent form;
• Female participants with fertility and male participants with fertility partners must agree to use reliable contraceptive measures within 6 months after screening and the last treatment.

Exclusion criteria

• Patients who are known to be intolerant to capecitabine or allergic to any therapeutic drug, or who are participating in clinical studies of other new drugs;
• Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction;
• Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma;
• Sever heart disease;
• Central nervous system metastasis with clinical symptoms;
• Serious infections ;
• Within 4 weeks of signing the informed consent form, receive systemic hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone per day. Subjects with a systemic hormone dose ≤ 10mg prednisone per day or inhaled/topical corticosteroids can be enrolled in the study;
• Patients with active chronic hepatitis B or active hepatitis C.
• A history of interstitial pneumonia or other autoimmune diseases.
• HIV infection;
• Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease;
• Less than 6 weeks after major organ surgery;
• Pregnant or breast feeding;
• Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent;
• Other researchers have determined that it is not suitable to participate in this trial.
• Those who refuse or are unable to sign the informed consent form.