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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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