Cytoreductive Surgery Combined With HIPEC and Chemotherapy for Gastric Cancer With Peritoneal Metastasis

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: Capecitabine; Cisplatin; Fluorouracil

Criteria

Inclusion Criteria:

• Age from over 18 to under 75 years

• Histologically proven primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy

• Diagnosed with clinical T1-4N0-3M1（distant metastases confined to peritoneum, P1）according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition by laparoscopic exploration

• Localized peritoneal metastasis with peritoneal cancer index(PCI) less than 20

• Resection of primary tumor and metastasis is anticipated to reach the CC0 status(no residual tumor )

• Performance status of 0 or 1 on Eastern Cooperative Oncology Group(ECOG) scale

• Written informed consent

Exclusion Criteria:

• Adenocarcinoma of esophageal-gastric junction(AEG) that requires thoracotomy

• Distant metastases not confined to peritoneum, including liver (H1), para-aortic lymphnode (stations 16a1 and/or b2), lung, brain, bone and other organs

• Histologically proven Human epidermal growth factor receptor 2(HER2)-neu overexpressing adenocarcinoma

• History of previous neoadjuvant chemotherapy , radiotherapy or clinical trial treatment within 3 months

• Contraindication for anesthesia, surgery, chemotherapeutic agents or HIPEC

• Women of child-bearing potential who are pregnant or breastfeeding

• History of prior/other malignancies within the 5 years prior to enrollment

• Cerebrovascular accident occurred within 6 months (myocardial infarction, unstable angina, cerebral infarction, or cerebral hemorrhage)

• History of continuous systematic administration of corticosteroids within one month

• Requirement of simultaneous surgery for other disease

• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

• FEV1<50% of predicted values