The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer (SIEG)

Anhui Medical University

Status and phase: Unknown; Phase 2

Conditions: Stage IV Gastric Cancer With Metastasis

Treatments: Drug: second line chemoregime for advanced gastric cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT01964027

SIEG

Details and patient eligibility

About

This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.

Full description

The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, ,

The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 18 to 70 years
• The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy
• Measurable lesions outside the stomach
• ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1
• Expected survival time of at least 3 months
• Subjects receiving treatment for other damage caused has been restored, which it accepted the nitroso or mitomycin interval> 6 weeks, the acceptance of other cytotoxic drugs, radiotherapy or surgery> = 4 weeks, and the wound has completely healed. No bleeding, no nervous system transferred
• Blood and organ function was normal

Exclusion criteria

• Comorbid with other malignant tumors
• Pregnant and lactating women
• with the disease of endangering patient's safety and affecting the completion of the study
• Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure> 140mmhg, diastolic blood pressure> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction
• Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks
• Participated in clinical trials with other drugs or using other drugs during past 4 weeks
• Lesions which can't be measured such as pleural effusion, ascites, peritoneal cancer lesions, diffuse liver and bone metastases violation, brain metastasis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Irinotecan plus epirubicin

Experimental group

Description:

Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment \* 6 cycles as the second line chemoregime for advanced gastric cancer

Treatment:

Drug: second line chemoregime for advanced gastric cancer