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Table 1 Patient eligibility—inclusion and exclusion criteria

From: Weekly paclitaxel plus ramucirumab versus weekly nab-paclitaxel plus ramucirumab for unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy—the P-SELECT trial (WJOG10617G)—a randomised phase II trial by the West Japan Oncology Group

Inclusion criteriaExclusion criteria
1) Age ≥ 20 years
2) Informed consent
3) Histological diagnosis of primary gastric or oesophagogastric junction adenocarcinoma
4) Unresectable gastric or oesophagogastric junction cancer, recurrent gastric, or oesophagogastric junction cancer
5) At least one of i) to iv) listed below, which indicates peritoneal dissemination
i) Contrast enema/enterography: obvious malignant intestinal stenosis or deformation of the intestinal wall
ii) CT: obvious peritoneal mass or ascites, hydronephrosis not attributable to a cause other than peritoneal dissemination, increased density of peritoneal adipose tissue, thickening of the intestinal wall
iii) Clinical signs: palpable metastasis in the pouch of Douglas, board-like rigidity of the abdomen not attributable to a cause other than peritoneal dissemination
iv) Operative findings (including exploratory laparoscopy): lesions suggestive of peritoneal dissemination, confirmed by pathological diagnosis of peritoneal dissemination
6) Patients without massive pleural effusion
7) Patients without advanced central nervous system (CNS) metastases
8) Patients with evaluable lesions (whether or not lesions are measurable is irrelevant)
9) Intolerant or refractory to first-line therapy, including fluoropyrimidine
10) Patient without history of using taxane or angiogenesis inhibitors
11) Patients without history of radiotherapy including irradiation of the abdominal region
12) ECOG performance status: 0, 1, or 2
13) Adequate organ function
1) Active multiple cancer (synchronous multiple cancer or metachronous multiple cancer where patient has been disease-free for less than 3 years); however, lesions corresponding to carcinoma in situ (intraepithelial carcinoma) or intramucosal cancer assessed as cured by local treatment are not classified as active multiple cancers.
2) History of sensitivity to any of the drugs used in this study (including alcohol or albumin sensitivity)
3) Patients with a history of surgery under general anaesthesia within 28 days
4) Patients who have had deep vein thrombosis, pulmonary embolism, or another major form of thromboembolism up to 12 weeks prior to enrolment
5) Palliative ascites aspiration (excluding diagnostic puncture for laboratory tests) within the past 2 weeks
6) Active infection requiring systemic treatment
7) Uncontrolled hypertension despite hypotensive drug therapy
8) Diabetes under treatment with continuous insulin use or uncontrolled diabetes
9) Patients with severe pulmonary disease
10) Unstable angina (attacks occurring or exacerbated within the past 3 weeks) or myocardial infarction within the past 3 months
11) Serious haemorrhagic disorder or vasculitis or an episode of serious gastrointestinal bleeding
12) Grade 2 or worse peripheral sensory neuropathy
13) Patients with liver cirrhosis (Child Pugh B or C) or previous hepatic encephalopathy
14) Patients with intestinal obstruction
15) Patients receiving continuous systemic administration of steroids
16) Patients receiving antiplatelet drugs
17) Mental illness or mental symptoms that would interfere with participation in the study
18) Pregnant, breast-feeding, a chance of pregnancy, or expecting to give birth
19) Patients deemed unsuitable as study subjects by an investigator for any other reason