HIPEC, Intravenous Chemotherapy and Surgery for the Treatment of Advanced GC With Peritoneal Metastasis

Phase 2

• Conditions: Gastric Cancer
• Interventions: Other: HIPEC,Chemotherapy AND surgery

• Registration Number: NCT02549911
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-14
• Last Update Submitted: 2015-09-14
• Study First Posted: 2015-09-15
• Last Update Posted: 2015-09-15
• Primary Completion: 2016-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIPEC,Chemotherapy AND surgery	HIPEC,Chemotherapy AND surgery	1. surgical exploration,if PCI\<20,then we perform this study 2. HIPEC（RHL-2000B, Madain Medical Devices Co., Ltd., Jilin, China): Taxol (Paclitaxel Injection) 75 mg/m2, twice, within 72 hours after surgical exploration ; oral chemotherapy:S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules): 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. 3. chemotherapy(3 cycles) : Taxol 150mg/m2,d1, S-1: 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. 4. surgery:Secondary surgical exploration:if PCI less than 20,then perform the cytoreductive surgery(resection of primary tumors and metastases ) 5. after the surgery,HIPEC for two cycles,and PS chemotherapy for 3 cycles

Primary Outcome Measures

Name	Time	Method
R0 resection	3 months	the rate of R0 resection

Secondary Outcome Measures

Name	Time	Method
Adverse Events	6 months	Number and degree of Adverse Events
Overall survival time	3 years	the overall survival time

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China