Comparison of SEEOX and SOX Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Chemotherapy is an important therapeutic method for unresectable gastric cancer patients. However, there is currently no established standard chemotherapeutic regimen for gastric cancer. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. The investigators estimate that combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy may be a safe and promising regimen in unresectable gastric cancer patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Treatments: Epirubicin; Etoposide; Etoposide phosphate; Oxaliplatin

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group(ECOG) score 0-2

• Ambulatory males or females, aged 30-70 years.

• Unresectable gastric cancer (Tumors with bulky nodal metastases surrounding the celiac artery and its branches or invasion of adjacent structures such as pancreas, omentum, esophagus, and aorta were considered unresectable)

• Life expectancy more than 3 months

• Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

• Normal hepatic, renal, and bone marrow function (GPT<2 fold of upper limit value; white blood cell count>4000/dl, Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value)

Exclusion Criteria:

• Patients can not bear surgical procedure.

• Pregnant or lactating women.

• Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.

• History of another malignancy within the last five years.

• History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.

• Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.

• Organ allografts requiring immunosuppressive therapy.

• Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.

• Moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN).

• Hypersensitivity to any drug of the study regimen.

• With abdominal cavity implantation metastasis or distant metastasis.

• Unwilling or unable to comply with the protocol for the duration of the study.