Hyperthermic Intraperitoneal Chemotherapy, Intravenous Chemotherapy Combined With Surgery for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

Zhejiang Cancer Hospital1 site in 1 country40 target enrollmentSeptember 2015

ConditionsGastric Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Gastric Cancer
Sponsor: Zhejiang Cancer Hospital
Enrollment: 40
Locations: 1
Primary Endpoint: R0 resection
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

Detailed Description

To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

September 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.
•Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
•Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
•ECOG (Eastern Cooperative Oncology Group) : 0\~2
•Age: 18\~75 years old
•Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>1.5×109/L, PLT\>100×109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl
•Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
•Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
•Not participating in other study projects before and during the treatment
•Signed the Informed Consent Form

Exclusion Criteria

•Not conforming to above inclusion criteria
•Distal metastasis to lung, liver, or para aortic lymph node metastasis
•Ever operation on the stomach
•Operation intolerance due to other systemic basic diseases
•Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
•Allergy to the drugs in this protocol
•Pregnant or lactating women
•Women at childbearing age and of pregnancy desire during the study