To Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer

Inclusion Criteria:

• 1 Voluntarily joined the study and provide written informed consent and authorizationpermitting release of Protected Health Information.
• 2 Male or female patient ≥18 and ≤75 years of age, an Eastern Cooperative OncologyGroup (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks.
• 3 Histologically or cytologically proven diagnosis of nasopharyngeal cancer (NPC),Stage IVb or not amenable for or local treatment (based on 2017, the 8th edition ofthe American Joint Committee on Cancer (AJCC) staging system of tumor-node-metastasis (TNM) of nasopharyngeal cancer).
• 4 Subject meets one of the following criteria:
• Arm 1: Progression (Tumor-imaging proven) after platinum-based chemotherapy andTumor Immunotherapy (PD-1/PD-L1 Checkpoint Inhibitors, etc.).
• Attention: Progression during therapy or after therapy within 6 months,neoadjuvant/ adjuvant therapy, radical chemoradiotherapy are considered as thefirst-line treatment.
• Arm 2 and 3: Not received systemic anti-tumor therapy for recurrent / metastaticnasopharyngeal cancer.
• Attention: Progression after therapy more than 6 months, neoadjuvant/ adjuvanttherapy, radical chemoradiotherapy are not considered as the first-linetreatment.
• 5 Have at least 1 measurable disease defined by Response Evaluation Criteria in SolidTumors Version 1.1 (RECIST 1.1).
• 6 Have adequate baseline function and performance status：
• a) Standard hematology test (no blood or product transfusions for a period of atleast 7 days prior to enrollment). i. Hemoglobin (HGB) >90 g/L; ii. Neutrophil count (NEUT) ≥1.5 × 109/L; iii.Platelets (PLT) ≥75 × 109/L;
• b) Serum chemistry i. Alanine Aminotransferase (ALT) and AspartateAminotransferase (AST) ≤ 2.5 upper limit of normal (ULN) or ≤ 5 x ULN forsubjects with hepatic metastatic tumor; ii. Bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULNfor subjects with Gilbert Syndrome; iii. Creatinine ≤ 1.5 x ULN or CreatinineClearance ≥ 60 mL/min;
• c) Blood Coagulation Test i. Activated Partial Thromboplastin Time (APTT),International Normalized Ratio (INR) and Prothrombin Time (PT) ≤ 1.5 (Noanticoagulant therapy);
• d) left ventricular ejection fraction (LVEF) ≥ 50%;
• 7 Women of child-bearing potential must agree to use contraceptive method(s)throughout the study and for at least 180 days after the last dose of assignedtreatment. Serum pregnancy test negative within 7 days before enrollment and must benon-lactating.

Exclusion Criteria:

• 1 Complicated disease and history:

1. Has developed other malignant tumors within 3 years or is currently sufferingfrom;
2. With factors affecting take medicine orally (such as unable to swallow drugs orbowel obstruction, etc.)
3. Unmitigated toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment, excluding hair loss and peripheralsensory nerve disorders related to platinum-based chemotherapy;
4. Received major surgical treatment, significant traumatic injury or long-termunhealed wounds or fractures (excluding needle biopsy for diagnosis, endoscope,etc.) within 28 days prior to the commencement of study treatment;
5. With arterial/venous thrombotic events within 6 months, such as cerebrovascularaccidents (including temporary ischemic attack, cerebral hemorrhage), deep venousthrombosis and pulmonary embolism;
6. With active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizedpneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment oractive pneumonia with clinical symptoms;
7. History of psychotropic substance abuse and inability to quit or with mentaldisorders;
8. Received allogeneic bone marrow transplantation or solid organ transplantation;
9. Subjects with any severe and/or uncontrolled disease:

• i. Uncontrolled hypertension (defined as systolic BP >150 mm Hg or diastolicBP > 100 mm Hg pressure)
• ii. Grade 2 or greater cardiac ischemia, myocardial infarction or cardiacarrhythmia (including QTc ≥ 480 ms) ;and New York Heart Association (NYHA)Grade II or greater congestive heart failure;
• iii. Active or uncontrolled infections;
• iv. Decompensated liver cirrhosis and active hepatitis (Hepatitis Breference: HBsAg positive, and HBV DNA> 2500 copy/mL or > 500 IU/mL;Hepatitis C reference: HCV antibody positive, and HCV RNA > ULN);
• v. Renal failure requiring hemodialysis or peritoneal dialysis；
• vi. Known history of immunodeficiency infection;
• vii. Urinalysis：urine protein ≥ ++，and confirmed 24-hour urinary protein > 1.0g;
• 2 Tumor-related symptoms and treatment:

1. History of surgery, chemotherapy, radiation or other anti-tumor therapy within 4weeks prior to enrollment (calculated from the date of the last dose);
2. History of Chinese patent drugs with anti-tumor indications approved by NationalMedical Products Administration (NMPA) (including compound cantharide capsule,Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oilinjection/capsule, Xiaoaoping tablet/injection, Huabenin capsule, etc.) within 2weeks before enrollment;
3. History of Tumor Immunotherapy of TGF-β inhibition;
4. Previously received bevacizumab, arotinib, apatinib, renvatinib or otheranti-vascular targeted drug therapy;
5. History of secondary radiotherapy;
6. Imaging (CT or MRI) evidence of tumor invading the significant blood vessels orlikely to invade and cause fatal massive bleeding during study, accessed byinvestigators;
7. With uncontrolled pleural effusion, pericardial effusion, or ascites thatrequires repeated drainage;
8. Known uncontrolled or symptomatic active central nervous system (CNS) metastasis (characterized by clinical symptoms, brain edema, spinal cord compression,cancerous meningitis, leptomeningeal disease and /or progressive growth); (exclude those, with the history of CNS metastasis or spinal cord compression,clinical symptoms stabilized less than 4 weeks after discontinuation ofdehydrants and steroids);

• 2 Research Treatment Related:

1. History of live attenuated vaccine vaccination within 28 days prior to enrollmentor planing of live attenuated vaccine vaccination during the study period;
2. Definite bleeding tendency or bleeding symptoms with significant clinicalsignificance within 28 days prior enrollment, including gastrointestinalbleeding, nasal bleeding (excluding epistaxis and retractive runny nose), andwith hemorrhagic diseases or coagulation disorders;
3. History of hemoptysis or hemoptysis within 28 days prior enrollment (defined ascoughing or coughing out ≥ 1 teaspoon of blood or small blood clots or onlycoughing up blood without sputum) , blood in sputum are not excluded;
4. Severe allergy history of antibody drugs or others;
5. History of active autoimmune disease requiring systemic treatment within 2 yearsprior to enrollment (e.g. palliative drugs, corticosteroids, orimmunosuppressants) .

• i. Including autoimmune hepatitis, interstitial pneumonia, uveitis,enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism or multiplesclerosis;
• ii. Exclude Skin diseases without systemic treatment, such as vitiligo,psoriasis and hair loss；
• iii. Including asthma requiring medical intervention with bronchodilators;
• iv.Alternative therapy (such as thyroxine, insulin, or physiologicalcorticosteroids for adrenal or pituitary insufficiency) is not considered assystemic therapy;

6. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy orany other form of immunosuppressive therapy. (dose of >10mg/ day prednisone orother equivalent efficacy hormone), and continued to use within 2 weeks prior toenrollment;

• 4 History of participating in other anti-tumor clinical trials in the previous 4weeks;
• 5 Other damage to the safety of patients or other situations affecting patients tocomplete the study, assessed by investigators.