|
| 审讯 |
研究组 |
相 |
肿瘤部位 |
切缘 |
淋巴结状态 |
总生存期(月) |
疾病复发 |
|
| 正试验 |
| BILCAP [20] |
对比观察(1 : 1) |
III 开放标签
|
ICC:(19%) PCC:(29%) DCC:(35%) GBC:(18%) |
R0:(62%) R1: (38%) |
N0: (53%) N1: (47%) |
ITT: 51·1比36·4 HR 0·81 [95%CI 0·63-1·04]; PPA: 53与36 HR 0·75 [95%CI 0·58-0·97]; |
RFS中位数(个月) ITT: 24·4对17·5 HR 0.75 [95%CI 0·58-0·98]; PPA: 25.9与17.4 HR 0·70 [95%CI 0·54-0·9]; |
|
| 负试验 |
| Takada等。[16] |
丝裂霉素C和单独5-氟尿嘧啶与手术 |
III 开放标签
|
胰腺:(34%) 胆管:(27%) GBC:(28%) 特氏壶腹:(11%) |
疗效: Noncurative: |
未报告 |
ITT(GBC仅队列): 16.4与14.1(
) 在GBC 5组年生存率(%)的PPA:26.0%比14.4%,(
) |
5年DFS率(%)在GBC人群: 20.3%比11.6%; |
| PRODIGE 12 ACCORD 18 [19] |
对比观察 |
III 开放标签
|
ICC:(44%) PCC:(8%) DCC:(28%) GBC:(20%) |
R0:(87%) R1: (13%) |
N0:(50%) N1:(36%) N2:(1%) NX:(13%) |
75.8与50.8 HR 1.08 [95%CI 0.70-1.66]; |
RFS中位数(个月): 30.4与18.5 HR 0.88 [95%CI 0.62-1.25]; |
| BCAT [23] |
对比观察(1 : 1) |
III 开放标签
|
PCC:(45%) DCC:(55%) |
R0:(91%) R1:(11%) |
N0:(65%) N1:(35%) |
62.3与63.8 HR 1.01 [95%CI 0.70-1.45]; |
RFS中位数(个月): 36.0与36.9 HR 0.93 [95%CI 0.66-1.32]; |
| ESPAC-3 [84] |
Fluorouracil/folinic acid vs. gemcitabine vs. observation (1 : 1 : 1) |
III 开放标签
|
壶腹:(69%) 胆管:(22%) 其他:(8%) |
R0:(84%) R1:(16%) |
N0:(41%) N1:(59%) |
38.9与45.7与35.2 HR为FU与观察:0.95 [95%CI 0.71-1.28]; HR为吉西他滨与观察:0.77 [95%CI 0.57-1.05]; |
RFS中位数(个月): 23.0与29.1与19.5 HR为FU与观察:0.69 [95%CI 0.51-0.95]; HR为吉西他滨与观察:0.68 [95%CI 0.50-0.95]; |
|