Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis

Peking University20 enrolled

Overview

The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer Metastases to Perineum

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proved gastric adenocarcinoma. * Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid. * Potentially resectable gastric cancer. * ALT, AST \< 80U/L; Total Bilirubin \< 30μmol/L; WBC \> 4x10\^9/L; PLT \> 100x10\^9/L; Cr \< 1.5 fold normal value. * ECOG 0-2 points. * Expected survival time longer than 3 months. * Informed consent. Exclusion Criteria: * Recurrent gastric cancer. * Pregnant or lactating women. * Allergic to oxaliplatin or paclitaxel. * Abnormal liver/kidney function. * Serious heart/metabolic disease.

Outcomes

Primary Outcomes

Overall Survival

Time frame: every 3 month postoperation up to 24 months

Secondary Outcomes

Safety

Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)