This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.
18-75 years of age;
ECOG PS ≤3;
pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;
peritoneal carcinomatosis established by imaging data or pathological evidence;
treated by a combination regimen containing all the study drugs;
allergy to any of the study drugs;
HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
strangulated intestinal obstruction;
Parallel
Docetaxel
Drug25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Oxaliplatin
Drug85 mg/msquare metre, D1, D15, repeat every 4 weeks.
Fluorouracil
Drug1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.
60-day Obstruction Clearance Rate
proportion of participants who achieved obstruction clearance within 60 days from start of treatment
30-day Obstruction Clearance Rate
proportion of participants who achieved obstruction clearance within 30 days from start of treatment
Time to Obstruction Clearance
interval from start of treatment to obstruction clearance
Obstruction Clearance Duration
interval from obstruction clearance to the next malignant bowel obstruction
Safety in terms of Adverse Events
according to Common Terminology Criteria for Adverse Events version 5.0
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Sixth Affiliated Hospital, Sun Yat-sen University
Lead sponsor
Guangdong Provincial People's Hospital
Sponsor institution
Guangdong Provincial People's Hospital
Collaborator
