A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer

Inclusion Criteria:

• The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent.
• Male or female. aged between 18 and 75 years
• Histopathologically confirmed advanced advanced gastric or gastroesophageal junction cancer, and Documented progression during first-line fluoropyrimidine- and platinum- containing chemotherapy, or during the 3 months following the last cycle of such chemotherapy (or during the 6 months following the last dose of adjuvant therapy or new adjuvant therapy containing fluoropyrimidine and platinium).
• At least one Measurable lesion.
• ECOG Performance status (PS) score, 0-1 level.
• A life expectancy of >3 months.
• Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin concentration ≥90g/L (allowing blood transfusion); and platelet count ≥80×109/L.
• Adequate hepatic function, as defined by: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (liver metastases patients ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN).
• Adequate renal function, as defined by: serum creatinine level≤ 1.5 × ULN, or creatinine clearance ≥ 50ml / min when serum creatinine level> 1.5 × ULN.
• Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5× ULN, activated partial thromboplastin time (aPTT) ≤1.5 x ULN.
• 24-hour urine protein quantitation is <1g（24-hour urine protein quantitative test should be performed when urine protein ≥1+ is found during screening visit）.
• Subjects (male and female) who have fertility must agree to use reliable contraceptive methods during the trial and in 3 months after the last administration. Female subjects in childbearing age must be negative for blood pregnancy test prior to enrollment.

Exclusion Criteria:

• Previously administrated with anti-angiogenic drugs or paclitaxel.
• Systematic anti-tumor therapy (non-anti-angiogenic drugs or paclitaxel) such as chemotherapy, radiotherapy, macromolecular targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks before the first dose of investigational drug, except for the following: nitrourea or mitomycin C is within 6 weeks before the first dose, oral fluorouracil and small molecule targeted drugs are within 2 weeks or 5 half-life of the drug(whichever is longer) before the first dose，Chinese medicine with anti-cancer indications is within 2 weeks before the first dose.
• Has participated in a clinical study of a non-approved experimental agent within 4 weeks prior to screening visit.
• Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy)， or would undergo planned surgery during the study.
• Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA > ULN.
• Patients with previously confirmed malignant tumors.
• History of arterial thrombosis or deep vein thrombosis within 6 months prior to screening, or a bleeding event no less than Grade level 3 within 2 months prior to screening， or the investigator determines that there is a risk of bleeding.
• History of severe cardiovascular and cerebrovascular diseases.
• Subjects with confirmed brain tumor metastases，but subjects in steady situation can be enrolled.
• Active bleeding confirmed by gastroscopy when fecal occult blood positive (only subjects with primary lesions not removed need to do fecal occult blood test.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 12 months before screening visit.
• Thoracic，abdominal or pericardial effusion that cannot be controlled by repeated drainage or with obvious symptoms.
• Has a nonhealing wound, serious ulcer, or unrecovered bone fracture.
• Active infections requiring systemic treatment, including but not limited to active tuberculosis.
• Using anticoagulation and antiplatelet drugs.
• Female subjects who is pregnant (confirmed by urine or serum pregnancy test) or lactating.
• Has a known serious allergy reaction to recombination monoclonal antibody (MAb) drug, ,or infusion reaction.
• Has known alcohol or drug dependency.