Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Patients With Advanced Gastric Cancer
Brief Summary: This study will compare treatment with bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line therapy in patients with locally advanced or metastatic gastric cancer who had not received prior chemotherapy for advanced or metastatic disease.


Options:
A: Inclusion Criteria:

* Signed informed consent
* histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
* Metastatic disease or locally advanced, unresectable disease
* Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
* Organs are functioning well (liver, kidney, blood)
* Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion Criteria:

* First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline
* Previous systemic therapy with other anti-angiogenic drugs
* Uncontrolled high blood pressure
* Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
* Evidence of central nervous system (CNS) metastasis at baseline
B: Inclusion Criteria:

* Written informed consent obtained prior to any study specific procedures.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Life expectancy of at least 3 months.
* Able to comply with the protocol.
* Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy.
* Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumours (RECIST).
* Patient not receiving anticoagulant medication must have an International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x Upper Limit of Normal (ULN) within 7 days prior to randomisation.

Exclusion Criteria:

* Previous chemotherapy for locally advanced or metastatic gastric cancer. Patients may have received prior neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to randomisation.
* Previous platinum or anti-angiogenic therapy (ie, anti-vascular endothelial growth factor \[VEGF\] or VEGF receptor tyrosine kinase inhibitor, etc.).
* Patients with locally advanced disease who are candidates for curative therapy (including operation and/or chemotherapy and/or radiotherapy).
* Radiotherapy within 28 days of randomisation.
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomisation, or anticipation of the need for major surgery during the course of the study treatment (planned elective surgery).
* Minor surgical procedures within 2 days prior to randomisation.
* Evidence of central nervous system (CNS) metastasis at baseline.
* History or evidence upon physical/neurological examination of CNS disease unrelated to cancer unless adequately treated with standard medical therapy, eg, uncontrolled seizures.
* History of another malignancy which could affect compliance with the protocol or interpretation of results.
* Inadequate bone marrow function.
* Inadequate liver function.
* Inadequate renal function.
* Uncontrolled hypertension or clinically significant (ie, active) cardiovascular disease.
* Active infection requiring intravenous antibiotics at randomisation.
* History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
* Serious or non-healing wound, peptic ulcer, or (incompletely healed) bone fracture.
* Active gastrointestinal bleeding.
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of randomisation.
* Neuropathy (eg, impairment of hearing and balance) ≥ grade II according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
* Chronic daily treatment with aspirin or clopidogrel.
* Chronic daily treatment with oral corticosteroids; inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed.
* Known hypersensitivity to any of the study drugs or excipients or to Chinese hamster ovary cell products or to other recombinant human or humanised antibodies.
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that may affect patient compliance with the study, or place the patient at high risk from treatment complications.
* Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Pregnant or lactating females.
* Women of childbearing potential not using effective nonhormonal (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) means of contraception.
* Sexually active men unwilling to practice contraception during the study.
* Current or recent (within the 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study.
C: Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
2. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
3. No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
4. ECOG Performance Status of 0 to 2
5. Life expectancy of at least 3 months after registration
6. Written informed consent
7. Age of 20 to 74 years with either gender
8. Adequate Major organ functions within 14 days before registration

Exclusion Criteria:

1. Positive HER2 status
2. Previous history of fluoropyrimidines therapy within 6 months prior to registration
3. Previous treatment with platinum agents
4. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
5. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
6. More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
7. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
8. Active hepatitis
9. Heart disease that is serious or requires hospitalization, or history of such disease within past year
10. Having complication that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)
11. Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
12. Chronic diarrhea (watery stool or ≥4 times/day)
13. Active gastrointestinal bleeding
14. Body cavity fluids requiring drainage or other treatment
15. Clinical suspicion or previous history of metastasis to brain or meninges
16. Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
17. Unwillingness to practice contraception
18. Poor oral intake
19. Psychiatric disorders which are being or may need to be treated with psychotropics
20. Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
D: Inclusion Criteria:

* Histologically confirmed adenocarcinoma
* Unresectable and recurrent gastric cancer
* Age 20 to 74
* Performance status 0, 1, or 2 (ECOG)
* Life expectancy 3 months
* No prior chemotherapy or radiotherapy for gastric cancer
* Able to take oral medication
* Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
* Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm\^3 Platelet ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL
* Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
* Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min

Exclusion Criteria:

* Pregnant or nursing
* Bleeding from gastrointestinal tract or no diarrhea
* Hypersensitivity to TS-1 or CDDP
* Psychiatric disorder that would preclude study compliance or giving informed consent
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality
* Serious illness or medical condition
* Brain metastasis
* Ascites requiring drainage

Answer: B