PMID- 33985455
OWN - NLM
STAT- MEDLINE
DCOM- 20211018
LR  - 20240327
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 21
IP  - 1
DP  - 2021 May 13
TI  - 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.
PG  - 545
LID - 10.1186/s12885-021-08275-9 [doi]
LID - 545
AB  - 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/m(2), 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.
FAU - Chang, Chen
AU  - Chang C
AD  - Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan 
      University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan, China.
FAU - Li, Xiaofen
AU  - Li X
AD  - Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan 
      University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan, China.
FAU - Cao, Dan
AU  - Cao D
AD  - Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan 
      University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan, China. 
      hxcaodan2019@163.com.
LA  - eng
GR  - 81773097/National Natural Science Foundation of China/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20210513
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 0 (Albumins)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 0 (Drug Combinations)
RN  - 0 (Gemcitabine)
RN  - 5VT6420TIG (Oxonic Acid)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 150863-82-4 (S 1 (combination))
RN  - 1548R74NSZ (Tegafur)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Young Adult
MH  - *Albumins/administration & dosage/adverse effects
MH  - *Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - *Carcinoma, Pancreatic Ductal/drug therapy/mortality
MH  - *Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives
MH  - Drug Combinations
MH  - Gemcitabine
MH  - *Oxonic Acid/administration & dosage/adverse effects
MH  - *Paclitaxel/administration & dosage/adverse effects
MH  - *Pancreatic Neoplasms/drug therapy/mortality
MH  - *Tegafur/administration & dosage/adverse effects
MH  - Clinical Trials, Phase I as Topic
PMC - PMC8117556
OTO - NOTNLM
OT  - Clinical protocol
OT  - Combination therapy
OT  - Gemcitabine
OT  - Nab-paclitaxel
OT  - Pancreatic ductal adenocarcinoma
OT  - S-1
COIS- The authors declare no competing interests.
EDAT- 2021/05/15 06:00
MHDA- 2021/10/21 06:00
PMCR- 2021/05/13
CRDT- 2021/05/14 05:36
PHST- 2021/03/28 00:00 [received]
PHST- 2021/04/29 00:00 [accepted]
PHST- 2021/05/14 05:36 [entrez]
PHST- 2021/05/15 06:00 [pubmed]
PHST- 2021/10/21 06:00 [medline]
PHST- 2021/05/13 00:00 [pmc-release]
AID - 10.1186/s12885-021-08275-9 [pii]
AID - 8275 [pii]
AID - 10.1186/s12885-021-08275-9 [doi]
PST - epublish
SO  - BMC Cancer. 2021 May 13;21(1):545. doi: 10.1186/s12885-021-08275-9.