Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer

University of Chinese Academy Sciences

Status and phase

Unknown

Phase 2

Conditions

Surgically-Created Resection Cavity

Drug Safety

Treatments

Drug: S-1 + Paclitaxel Chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01756183

SPECIAL

Details and patient eligibility

About

Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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