Combination of gemcitabine, nab-paclitaxel, and S-1(GAS) as the first-line treatment for patients with locally advanced or advanced pancreatic ductal adenocarcinoma: study protocol for an open-label, single-arm phase I study.
Combination of gemcitabine, nab-paclitaxel, and S-1(GAS) as the first-line treatment for patients with locally advanced or advanced pancreatic ductal adenocarcinoma: study protocol for an open-label, single-arm phase I study.
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吉西他滨、白蛋白结合型紫杉醇和 S-1(GAS) 组合作为局部晚期或晚期胰腺导管腺癌患者的一线治疗：开放标签、单组 I 期研究的研究方案
DOI：
10.1186/s12885-021-08275-9
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发表时间：
2021-05-13
期刊：
影响因子：
3.8
通讯作者：
Cao D
中科院分区：
文献类型：
--
作者：
Chang C;Li X;Cao D
背景
胰腺导管腺癌（PDAC）是最常见的恶性肿瘤之一。更强大的治疗手段有望为患者带来希望。在日本，每两周一次的吉西他滨/白蛋白结合型紫杉醇/S-1（GAS）被证明对局部晚期胰腺癌患者安全有效。本研究的目的是评价GAS（每3周重复一次）治疗局部晚期或晚期胰腺癌的可行性和毒性，并确定该联合治疗中S-1的推荐剂量。
方法
这是一项开放标签、单组、单中心I期试验。将入组经病理学诊断为局部晚期或晚期PDAC且既往未接受过全身治疗的患者，每3周一次接受GAS化疗（白蛋白结合型紫杉醇125 mg/m2，静滴，d1，8;吉西他滨1000 mg/m2，d1，8;剂量递增方案中不同剂量的S-1），直至出现疾病进展（PD）、不可耐受的不良事件（AE）或患者和研究者的要求。主要终点是最大耐受剂量（MTD）和剂量限制性毒性（DLT）。次要终点包括安全性、客观缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）。
讨论
本试验将调整GAS的给药方式，使其对中国患者更有效，同时探索这种调整的毒性和可行性。
试验注册
ChiCTR，（ChiCTR 1900027833）。2019年11月30日注册。
Background
Pancreatic ductal adenocarcinoma (PDAC) is still a highly fatal malignancy among the most common cancers. More powerful treatments are expecting to bring hope for patients. Biweekly gemcitabine/nab-paclitaxel/S-1 (GAS) was proved safe and effective for patients with locally advanced pancreatic cancer in Japan. The objective of this study is to evaluate the feasibility and toxicity of GAS (repeated every 3 weeks) in the treatment of locally advanced or advanced pancreatic cancer and determine the recommended dose of S-1 in this combination.
Methods
This is an open-label, single-arm, and single-center phase I trial. Patients who have been diagnosed with locally advanced or advanced PDAC pathologically without previous systemic treatments will be enrolled and be treated with GAS chemotherapy every 3 weeks (nab-paclitaxel 125 mg/m 2, ivgtt, day1, 8; gemcitabine 1000 mg/m2, day1, 8; different doses of S-1 within a dose escalation scheme) until the presence of disease progression (PD), intolerable adverse events (AEs), or requirement of patients and researchers. The primary endpoints are maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary endpoints include safety, objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).
Discussion
This trial will adjust the administration of GAS to make it more effective for Chinese patients, while exploring the toxicity and feasibility of this adjustment.
Trial registration
ChiCTR, (ChiCTR1900027833). Registered 30 November 2019.
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影响因子：
168.9
作者：
Quaresma, Manuela;Coleman, Michel P.;Rachet, Bernard
通讯作者：
Rachet, Bernard
影响因子：
3
作者：
Kondo, Naru;Murakami, Yoshiaki;Sueda, Taijiro
通讯作者：
Sueda, Taijiro
影响因子：
3.5
作者：
Assaf, Elias;Verlinde-Carvalho, Muriel;Culine, Stephane
通讯作者：
Culine, Stephane
影响因子：
4
作者：
Wang, Xiao-Fang;Huang, Wen-Feng;Jiang, Ji-Hao
通讯作者：
Jiang, Ji-Hao
DOI：
10.1056/nejmoa1304369
发表时间：
2013-10-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Von Hoff DD;Ervin T;Arena FP;Chiorean EG;Infante J;Moore M;Seay T;Tjulandin SA;Ma WW;Saleh MN;Harris M;Reni M;Dowden S;Laheru D;Bahary N;Ramanathan RK;Tabernero J;Hidalgo M;Goldstein D;Van Cutsem E;Wei X;Iglesias J;Renschler MF
通讯作者：
Renschler MF