| Eligibility |
Inclusion Criteria:
1. Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or
metastatic gastric or GEJ adenocarcinoma.
2. Male or Female at least 18 years of age
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Did not receive neoadjuvant or adjuvant treatment (chemotherapy,radiotherapy, or both)
for their disease within the last 6 months
5. Must agree to provide tumor tissue sample, either from a previous surgeryor biopsy ,
within 6 months or fresh, prior to the start of treatment in this study and Has a
PD-L1 status determined by immunohistochemistry (IHC) at a central laboratory
6. Has measurable or non-measurable (but assessable) disease as defined by RECIST 1.1 as
determined by investigator assessment.
7. Has adequate organ function.
8. Expected survival>=12 weeks.
9. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy
test at the timing of enrollment.
10. Participants of childbearing potential must be willing to use an adequate method of
contraception for the course of the study through 6 months after the last dose of
study medication.
Exclusion Criteria:
1. Suspicious active bleeding or obstruction phenomenon and Has difficulty in swallow
tablets and food
2. HER2-positive status
3. Has had previous therapy for unresectable locally advanced, recurrent or metastatic
gastric/GEJ cancer
4. Has received prior therapy with a dose of cisplatin>=300 mg/m-^2
5. Has grade = 2 peripheral sensory neuropathy
6. Known DPD enzyme deficiency status (>=grade 3 mucosal toxicity in previous
fluorouracil treatment)
7. Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD
L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or
co-inhibitory T-cell receptor
8. Is currently participating in and receiving study therapy ,except those in the
survival follow up period of an investigational agent study or non-interventional
study .
9. Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent)
or other immunosuppressive medications within 4 weeks of first dose. Inhaled or
topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic
reaction of i.v. contrast agent are permitted in the absence of active autoimmune
disease.
10. Received a live vaccine within 4 weeks of the first dose of study medication or plan
to receive live vaccine during study period.
11. Has had major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to
first dose of study medication, or anticipation of the need for major surgery during
the course of study treatment
12. Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous
meningitis. Subjects received prior treatment and have stable disease more than 4
weeks from first dose of study medication.
13. Clinical significant ascites, including which can be detected in percussion, had been
ever drained or still need to be controlled currently.
14. Bilateral moderate pleural effusion, or a large amount of pleural effusion on one
side, or has caused respiratory dysfunction requiring drainage.
15. Bone metastasis with risk of paraplegia.
16. Active, known or suspected autoimmune disease or has a history of the disease within
the last 2 years (subjects with vitiligo, psoriasis, alopecia or Grave's disease,
residual hypothyroidism due to autoimmune thyroiditis only requiring hormone
replacement, or type I diabetes mellitus only requiring insulin replacement, but not
required systemic treatment in the last 2 years, are permitted to enroll) .
17. Known primary immunodeficiency.
18. Known active tuberculosis.
19. Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.
20. Known>=grade 3 allergy or hypersensitivity to oxaliplatin,capecitabine or any
monoclonal antibodies.
21. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive).
22. Active or poorly controlled severe infection.
23. Symptomatic congestive heart failure (New York Heart Association grade II-IV) or
symptomatic, poorly controlled arrhythmia.
24. Poorly controlled arterial hypertension (SBP = 160mmHg or DBP = 100mmHg) with standard
treatment .
25. Prior arterial thromboembolism event, including myocardial infarction, unstable
angina, stroke and transient ischemic attack, within 6 months of enrollment.
26. Malnutrition requiring intravenous nutrition, subjects with malnutrition correction=4
weeks are permitted to enroll.
27. Prior deep vein thrombosis, pulmonary embolism or any other severe thromboembolism
events (implanted port or catheter caused thrombosis, or superficial vein thrombosis
are not considered as severe thromboembolism) within 3 months before enrollment.
28. History of uncontrolled metabolic disorder, non-malignant organ or systemic disease or
secondary carcinomatous reaction, with high medical risk and/or uncertainty of life
expectancy evaluation.
29. With hepatic encephalopathy, hepatorenal syndrome or hepatic cirrhosis of Child-Pugh
grade B or higher.
30. History of intestinal obstruction or the following diseases: inflammatory bowel
disease or extensive bowel resection (partial colonic resection or extensive small
bowel resection, concomitant with chronic diarrhea), Crohn's disease, ulcerative
colitis.
31. Known acute or chronic active hepatitis B infection (positive HBsAg and HBV DNA = 200
IU/mL or = 10^3 copies/mL positive) infection or acute or chronic active hepatitis C
(HCV antibody positive and HCV RNA positive) infection.
32. History of gastrointestinal perforation and /or fistula within 6 months before
enrollment.
33. Subjects with interstitial lung disease requiring steroids therapy.
34. Other primary malignancy, with the exception of:
1. Malignancy which achieved complete response for at least 2 years before
enrollment and do not need other treatment during study period;Curative
malignancy, without active disease in the last 5 years and with very low
recurrence risk;
2. Non-melanoma skin cancer or malignant freckle-like nevus with adequate treatment
and no evidence of recurrence ;
3. Adequately treated in-situ carcinoma.
35. Women who are pregnant or nursing.
36. Other acute or chronic diseases, mental illness, or abnormal laboratory test results
that may lead to the following outcomes: increase the risk of participating in study
or study drug administration, or interfere with the interpretation of the study
results and considered by investigator as "NOT" eligible to participate in this study.
|
