| Eligibility |
Inclusion criteria:
1. Age 18-75 years;
2. Patients must have histologically or cytologically confirmed metastatic or
unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. GEJ
adenocarcinoma may be classified according to Siewert's classification type I, II, or
III. Histological documentation of local recurrence or metastasis is strongly
encouraged, unless the risk of such a procedure outweighs the potential benefit of
confirming the metastatic disease;
3. Patients must have disease that can be measurable radiographically measurable disease
according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version
1.1);
4. Patients may have received no prior chemotherapy for metastatic or unresectable
disease. Patients may have received prior adjuvant therapy (chemotherapy and/or
chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy
and registration.
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;
6. An expected survival of =3months;
7. Major organ function has to meet the following criteria: (1) For results of blood
routine test: Hemoglobin (HB) =80 g/L, ANC (absolute neutrophil count) =1.5 × 109/L,
PLT (blood platelet) =75 × 109/L; (2) For results of biochemical tests: BLT (total
bilirubin) =1.25 × the upper limit of normal (ULN), ALT (Alanine aminotransferase) and
AST (aspartate aminotransferase ) =2.5 × ULN, liver metastases, if any, the ALT and
AST =5 × ULN, Serum Cr(creatinine)=1 × ULN, Endogenous creatinine clearance rate
>50ml/min;
8. The patient has an INR (international normalized ratio) =1.5 and an PTT(Partial
Thromboplastin Time)=3 seconds above the ULN if the patient is not on anticoagulation.
If a patient is on full-dose anticoagulants, the following criteria should be met for
enrollment: (1) The patient must have an in-range INR (usually between 2 and 3) on a
stable dose of warfarin or on stable dose of LMW (Low molecular weight) heparin; (2)
The patient must not have active bleeding or pathological conditions that carry high
risk of bleeding (e.g. tumor involving major vessels, known varices)
9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age
within 7 days before enrolment and the test result must be negative. Men and women of
childbearing potential must be willing to consent to using effective contraception
while on treatment and for at least 3 months thereafter.
10. Ability to understand informed consent and signing of written informed consent
document prior to initiation of protocol therapy.
Exclusion criteria:
1. Patients who have ascites requiring frequent drainage;
2. Patients who have received previous chemotherapy for the treatment of metastatic or
unresectable gastric or GEJ adenocarcinoma are ineligible;
3. Patients who have received previous pre- or post-operative chemotherapy or
chemoradiation are ineligible if therapy was completed less than 6 months prior to
study registration;
4. Patients with a history of another neoplastic disease within the past three years,
excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or
nonmetastatic prostate cancer;
5. Patients with brain or central nervous system metastases, including leptomeningeal
disease;
6. Pregnant (positive pregnancy test) or breast feeding;
7. Serious, non-healing wound, ulcer, or bone fracture;
8. Significant cardiac disease as defined as: unstable angina, New York Heart Association
(NYHA) grade II or greater, congestive heart failure, history of myocardial infarction
within 6 months;
9. Evidence of bleeding diathesis or coagulopathy;
10. History of a stroke or CVA within 6 months;
11. Clinically significant peripheral vascular disease;
12. Peripheral neuropathy grade =2 according to National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03;
13. Inability to comply with study and/or follow-up procedures;
14. Patients with any other medical condition or reason, in that investigator's opinion,
makes the patient unstable to participate in a clinical trial.
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