Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastr… (NCT03179579) | Clinical Trial Compass
UnknownPhase 3
Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastric Cancer
China88 participantsStarted 2017-08-01
Plain-language summary
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Gastic adenocarcinoma is diagnosed by histological and cytological examination.
✓. Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.
✓. According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20.
✓. 18 \< Age \< 70 year old
✓. Expected survival \> 3 months
✓. Performance status: ECOG 0-1
✓. Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/mm3, Platelet ≥ 100,000/mm3
✓. Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 2.5×ULN
Exclusion criteria
✕. Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.