Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

Inclusion Criteria:

1. Histologically or cytologically confirmed with recurrent or metastatic nasopharyngealcarcinoma which is not amenable to curative treatment with surgery and/or radiationtherapy. If the patient refuses biopsy of metastatic lesions, those diagnosed withmetastasis based on imaging evidence and clinical evidence can be enrolled.
2. Have failed for first-line platinum-based chemotherapy. Previously received first-lineplatinum-based chemotherapy for recurrent or metastatic disease and had diseaseprogression during or after treatment; or recurrence and metastases within 6 monthsafter treatment of platinum-based chemoradiation.
3. Age ≥ 18 years and ≤ 75 years, both genders.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
5. The life expectancy of at least 3 months.
6. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
7. Patients must have adequate organ function (without blood transfusion, without growthfactor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanineaminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN);Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula);serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however,patients with free Triiodothyronine [FT3] or free Thyroxine [FT4] levels ≤1× ULN maybe enrolled); INR, APTT≤1.5 x ULN.
8. All women with fertility potential must undergo a urine or serum pregnancy test duringscreening and the results are negative.
9. Written informed consent.

Exclusion Criteria:

• 1. Those with a history of severe immediate allergy to any drugs used in this study;

2. Patients who have previously received anti-EGFR monoclonal antibodies (nitolizumab,cetuximab) and anti-PD-1 monoclonal antibodies.
3. Combined with other malignant tumors; 4. Any of the following conditions existwithin 6 months before screening: myocardial infarction, severe/unstable angina,coronary artery/peripheral artery bypass grafting, symptomatic congestive heartfailure, cerebrovascular accident, transient cerebral ischemia Paroxysmal orsymptomatic pulmonary embolism. Patients with known coronary artery disease,congestive heart failure that does not meet the above criteria, or left ventricularejection fraction <50% must be treated with an optimized and stable medical regimen asdetermined by the treating physician, who may consult a cardiologist if appropriate;
4. Patients who have received any of the following treatments: (1) Have received any investigational drugs within 4 weeks before using theinvestigational drugs for the first time; (2) Use of large amounts of glucocorticoidsor other immunosuppressants (including but not limited to prednisone, dexamethasone,azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor within 4 weeksbefore treatment (drugs against TNF), or subjects who require hormonal therapy duringclinical trials. Other special circumstances need to be communicated with the sponsor.In the absence of active autoimmune disease, inhaled or topical steroids andadrenocortical hormone replacement at doses >10 mg/day prednisone therapeutic dose areallowed; (4) Those who have received anti-tumor vaccines or have received livevaccines within 4 weeks before the first administration of the study drug; (5) Haveundergone major surgery or serious trauma within 4 weeks before using the study drugfor the first time; (6) Enroll in another clinical study at the same time, unless itis an observational (non-interventional) clinical study or an interventional clinicalstudy follow-up; 6. Patients with active autoimmune diseases or a history ofautoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and can enter furtherscreening:
5. Controlled type 1 diabetes
6. Hypothyroidism (if it can be controlled with hormone replacement therapy alone)
7. Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis,alopecia)
8. Any other disease that is not expected to recur in the absence of external triggers 7.Active infections, including tuberculosis, hepatitis B, hepatitis C and humanimmunodeficiency virus. Patients with positive HBV surface antigen (HBsAg) but HBV DNA <1000 copies/mL are eligible to participate in this study; patients with positive HCVantibody test results can only participate if the HCV RNA polymerase chain reactiontest result is negative. Selected for this study; 8. History of idiopathic pulmonaryfibrosis, drug-induced pneumonia, organizing pneumonia (bronchiolitis obliterans),idiopathic pneumonia or evidence of active pneumonia on chest CT scan duringscreening; 9. No capacity for civil conduct or limited capacity for civil conduct; 10.Drug abuse or alcohol addiction, the patient has physical or mental illness, and theresearcher believes that the patient cannot fully or fully understand the possiblecomplications of this study; 11. Other serious acute or chronic medical conditionsthat may increase the risks related to the treatment of the research protocol, or mayinterfere with the interpretation of the research results and (according to theinvestigator's judgment) may make the patient unfit to participate in this study (including immune colitis, inflammatory colitis, Enteropathy, non-infectiouspneumonia, pulmonary fibrosis) or mental illness (including dementia and epilepsy,suicidal ideation or behavior recently, within the past year, or active) or abnormallaboratory tests; 12. Previously diagnosed with immunodeficiency or known diseasesrelated to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 13. Pregnant or lactating female patients, male or female patients withchildbearing potential but unwilling or unable to use contraception during the entirestudy period and for at least 1 year after the end of the treatment plan; 14. Thosewith recurrent nasopharyngeal carcinoma are suitable for surgical treatment.