Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world

Official Title
-----------------
Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer

Conditions
-----------------
Stage IV Gastric Cancer With Metastasis

Intervention / Treatment
-----------------
* Drug: S-1
* Drug: oxaliplatin
* Device: Hyperthermic Intraperitoneal
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 ≤ age Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis Didn't received any prior systemic chemotherapy Signed informed consent Exclusion Criteria: History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product Pregnancy or lactation women, Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3 Inadequate organ function which is defined as below: Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation); Symptomatic peripheral neuropathy Receiving a concomitant treatment with other fluoropyrimidines Fluoropyrimidines (DPD) congenital absence Other Situations which physicians suggesting are inadaptable for enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy Group<br>chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress | Drug: S-1<br>* 40-60mg/m^2 bid, days 1-14, oral，every 3 weeks.<br>Drug: oxaliplatin<br>* 100mg/m^2 days 1，intravenous infusion, every 3 weeks.<br>|
| Chemotherapy plus HIPEC Group<br>Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy | Drug: S-1<br>* 40-60mg/m^2 bid, days 1-14, oral，every 3 weeks.<br>Drug: oxaliplatin<br>* 100mg/m^2 days 1，intravenous infusion, every 3 weeks.<br>Device: Hyperthermic Intraperitoneal<br>* hyperthermic intraperitoneal chemoperfusion<br>Drug: Paclitaxel<br>* intraperitoneal perfusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS: Progression Free Survival | time from enrollment to disease progression or death | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS:overall survival | time from enrollment to death | 3 years | 
| Safety | measured by recording the subjects' Adverse Events according to CTCAE 4.03 | 3 years |