Drug Safety, Surgically-Created Resection Cavity
Conditions
Brief summary
Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer
Detailed description
To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric cancer.
Interventions
DRUGS-1 + Paclitaxel Chemotherapy
Dose of S-1: 60mg bid，Twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. Dose of Paclitaxel: 150 mg/m2, iv, 3h, at D1
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
-Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision) * 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, brain and bone (except the liver) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radical resection rate | 3 months | radical resection rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 6 months | Number and degree of Adverse Events |
| reaction rate | 2 months | the reaction rate of chemotherapy |
| overall survival time | 3 years | the overall survival time |
Countries
China
Contacts
Primary Contactxiangdong Cheng, MD
Outcome results
None listed