文档介绍：西妥昔单抗联化疗
1
Can target therapy break the bottleneck of chemotherapy in gastric cancer?
Current status of AGC chemothnded by Merck EMR62202-769
A phase II study of cetuximab (Erbitux®) with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer
西妥昔单抗联合顺铂/卡培他滨一线治疗进展期胃癌的II期临床研究
Histologically confirmed gastric or EGJ adenocarcinoma
Unresectable recurrent or metastatic disease
Age ≥ 18 years old
signed informed consent
Measurable disease according to the RECIST criteria
Previous neo-adjuvant or adjuvant treatment for gastric cancer, more than 6 month
No prior radiotherapy except at non-target lesion of the study more than 4 weeks
Life expectancy of ≥2 month
Karnofsky performance status ≥60
ALT and AST< times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥, Serum AKP < times ULN, Bilirubin level <
Serum creatinine < times ULN
WBC>4×109/L , absolute neutrophil count ≥4×109/L, platelet>100×109/L, Hb>9g/dl
Criteria for inclusion
Criteria for exclusion
Brain metastasis (known or suspected)
Previous systemic therapy for metastatic gastric cancer
Inability to take oral medication
Previous EGFR pathway-targeting therapy
Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
Heart failure, coronary artery disease, myocardial infarction within the last 6m
Known allergy to any study treatment
Pregnancy or lactation period
Any investigational agent within the past 28 days
Other previous malignancy within 5 year, except non-melanoma skin cancer
Previous adjuvant therapy with capecitabine+platinum, less than 6 months
Pre-existing neuropathy>grade 1
Legal incapacity
获得伦理通过，
第一例 接受治疗
完成17例疗效评价，8例PR，
完成第一阶段
完成全部病例入组
54例入组
2例 筛选失败，3例退出研究
49例 接受1周期以上治疗
47例 可评价疗效
，仍有2例患者生存
Study progression
Site No.
No. of enrolled patients.
N