Clinical trial NCT03121716 (phase 1, status: unknown status)
Conditions: nasopharyngeal carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: gemcitabine, cis-platinum
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18-70 years of age.

          2. Subjects diagnosed with pathological confirmed Primary metastatic nasopharyngeal
             carcinoma, or subjects with recurrent NPC that is unfit for local treatment.

          3. Subjects with recurrent and metastatic NPC who did't receive any Systemic
             chemotherapy, neoadjuvant chemotherapy, concurrent radiochemotherapy and adjuvant
             chemotherapy 6 month before first dose are excepted.

          4. ECOG performance status of 0 or 1.

          5. Life expectancy more than 12 weeks.

          6. Subjects enrolled must have measurable lesion(s) according to response evaluation
             criteria in solid (RECIST) v1.1.

          7. Adequate laboratory parameters during the screening period as evidenced by the
             following:

               -  Absolute neutrophil count ≥1.5*10E9/L;

               -  Platelets ≥100*10E9/L;

               -  Hemoglobin ≥9.0 g/dL;

               -  Albumin (ALB) levels ≥2.8 g/dL;

               -  Total bilirubin (TBIL)≥1.5 upper limit of normal (ULN)

               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 upper
                  limit of normal(ULN); for subjects with liver metastases, ALT and AST ≥5 ULN;

               -  creatinine clearance rate ≥50mL/min;

          8. Female subjects agree not to be pregnant or lactating from beginning of the study
             screening through at least 3 months after receiving the last dose of study treatment.
             Both men and women of reproductive potential must be willing and able to employ a
             highly effective method of birth control/contraception to prevent pregnancy. A highly
             effective method of contraception is defined as one that results in a low failure
             rate, that is, less than 1% per year when used consistently and correctly

          9. Able to understand and sign an informed consent form (ICF).

        Exclusion Criteria:

          1. Subjects with any active autoimmune disease or history of autoimmune disease, or
             history of syndrome that requires systemic steroids or immunosuppressive medications,
             including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis
             (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and
             hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy.
             Subjects with the following conditions will not be excluded from this study: asthma
             that requires intermittent use of bronchodilators, hypothyroidism stable on hormone
             replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions
             may be made with medical monitor approval;

          2. Known history of hypersensitivity to any components of the SHR-1210 formulation;

          3. Concurrent medical condition requiring the use of immunosuppressive medications, or
             immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10
             mg/day prednisone or equivalent are prohibited within 2 weeks before study drug
             administration. Note: corticosteroids used for the purpose of IV contrast allergy
             prophylaxis are allowed;

          4. Active central nervous system (CNS) metastases (indicated by clinical symptoms,
             cerebral edema, steroid requirement, or progressive disease);

          5. Uncontrolled clinically significant medical condition, including but not limited to
             the following:

               -  congestive heart failure (New York Health Authority Class &gt; 2),

               -  unstable angina,

               -  myocardial infarction within the past 12 months, or

               -  clinically significant supraventricular arrhythmia or ventricular arrhythmia
                  requiring treatment or intervention;

          6. Active infection or an unexplained fever; 38.5℃ during screening visits or on the
             first scheduled day of dosing (at the discretion of the investigator, subjects with
             tumor fever may be enrolled);

          7. History of immunodeficiency including seropositivity for human immunodeficiency virus
             (HIV), or other acquired or congenital immune-deficient disease;

          8. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease),
             psychiatric, or social condition deemed by the investigator to be likely to interfere
             with a subject's rights, safety, welfare, or ability to sign informed consent,
             cooperate, and participate in the study or would interfere with the interpretation of
             the results;

          9. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of
             reactivation based on institutional guidelines and tests. Testing may include the
             following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core
             antibody.