A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing

Inclusion Criteria

• •1. Patients volunteered to participate in this study and signed informed consent;
• •2. Aged ≥ 18 but ≤ 75 years, male or female;
• •3. Histologically confirmed to be locally advanced or metastatic salivary gland carcinoma;
• •4. Arm1: salivary gland carcinoma patients with HER-2 overexpression ； Arm 2: salivary gland carcinoma patients with AR-positive; Arm 3: salivary gland carcinoma patients without HER-2 alteration or AR-positive; Arm 4: salivary gland carcinoma patients with low HER-2 expression;
• •5. At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress);
• •6. ECOG Perfomance Status: 0\~1;
• •7. Estimated survival time ≥ 12 weeks;
• •8. The main organs function are normal, and meet the following requirements (within 7 days before the start of study treatment):
• •Blood routine examination(no blood transfusion within 14 days before screening, no granulocyte colony stimulating factor (G-CSF), no medication corrected):1) Hemoglobin (HB)≥ 90g / L;2) Neutrophil count (ANC) ≥ 1.5 × 109 / L;3) platelets (PLT) ≥ 80 × 109 / L; Blood biochemical tests are subject to the following criteria (no albumin is delivered 14 days prior to screening):1) Serum total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT), aspartate aminotransferase (AST\])\< 2.5 × ULN; if liver metastasis, ALT and AST ≤ 5 × ULN;3) Serum creatinine (Cr) ≤ 1 × ULN or endogenous creatinine clearance \> 50ml / min (Cockcroft-Gault formula); International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeds the range of normal controls ≤ 6 seconds; Urine protein \<2+ (if urine protein ≥ 2+, 24-hour urine protein can be quantified, 24-hour urine protein quantitation \<1.0g can be included);
• •9. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and volunteer to use appropriate methods during the observation period and within 8 weeks after the last study drug administration; for men, sterilization surgery should be performed, or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug;
• •10. Patient who are expected to have good compliance and can accept follow-up visit for the efficacy and adverse reactions according to the program requirements.