PMID- 37201078
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230521
IS  - 2078-6891 (Print)
IS  - 2219-679X (Electronic)
IS  - 2078-6891 (Linking)
VI  - 14
IP  - 2
DP  - 2023 Apr 29
TI  - A small-scale, exploratory real-world study of nab-paclitaxel combined with 
      oxaliplatin and tegafur in the perioperative treatment of advanced gastric 
      cancer: a study protocol for a real-world clinical trial.
PG  - 1131-1140
LID - 10.21037/jgo-23-131 [doi]
AB  - BACKGROUND: Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is an 
      optimized and improved derivative of paclitaxel with superior efficacy and fewer 
      adverse reactions, and it is widely used in the treatment of advanced gastric 
      cancer. However, there is a paucity of data regarding the safety and efficacy of 
      nab-paclitaxel combined with oxaliplatin (LBP) and tegafur in the treatment of 
      patients with advanced gastric cancer. METHODS: This analysis is a prospective, 
      single-center, open-label, historically controlled real-world study designed to 
      include 10 patients with advanced gastric cancer treated with nab-paclitaxel 
      combined with LBP and tegafur gimeracil oteracil potassium. The primary and main 
      efficacy outcomes are safety indicators, including the incidence of adverse drug 
      reactions and adverse events (AEs), as well as the outliers of laboratory 
      indicators and vital signs. The secondary efficacy outcomes are overall survival 
      (OS), objective response rate (ORR), disease control rate (DCR), and proportion 
      of dose suspensions, dose reductions and discontinuations. DISCUSSION: Based on 
      the findings of previous studies, we wished to assess the safety and efficacy of 
      nab-paclitaxel combined with LBP and tegafur in the treatment of advanced gastric 
      cancer. The trial requires constant contact and monitoring. The purpose is to 
      determine a superior protocol in terms of patient survival, and pathological and 
      objective response. TRIAL REGISTRATION: This trial has been registered with the 
      Clinical Trial Registry: NCT05052931 (registration date: 2021/9/12).
CI  - 2023 Journal of Gastrointestinal Oncology. All rights reserved.
FAU - Zheng, Jiyang
AU  - Zheng J
AD  - Department of Digestive Surgery, Xijing Hospital, The Fourth Military Medical 
      University, Xi'an, China.
FAU - Wang, Shu
AU  - Wang S
AD  - Department of Digestive Surgery, Xijing Hospital, The Fourth Military Medical 
      University, Xi'an, China.
FAU - Xu, Guanghui
AU  - Xu G
AD  - Department of Digestive Surgery, Xijing Hospital, The Fourth Military Medical 
      University, Xi'an, China.
FAU - Wang, Juan
AU  - Wang J
AD  - Department of Digestive Surgery, Xijing Hospital, The Fourth Military Medical 
      University, Xi'an, China.
FAU - Wang, Yuhao
AU  - Wang Y
AD  - Department of Digestive Surgery, Xijing Hospital, The Fourth Military Medical 
      University, Xi'an, China.
FAU - Luo, Jialin
AU  - Luo J
AD  - Department of Digestive Surgery, Xijing Hospital, The Fourth Military Medical 
      University, Xi'an, China.
FAU - Wang, Yan
AU  - Wang Y
AD  - Department of Gastroenterology, Xijing 986 Hospital, The Fourth Military Medical 
      University, Xi'an, China.
FAU - Yang, Jianjun
AU  - Yang J
AD  - Department of Digestive Surgery, Xijing Hospital, The Fourth Military Medical 
      University, Xi'an, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT05052931
PT  - Journal Article
DEP - 20230427
PL  - China
TA  - J Gastrointest Oncol
JT  - Journal of gastrointestinal oncology
JID - 101557751
PMC - PMC10186493
OTO - NOTNLM
OT  - Nanoparticle albumin-bound paclitaxel (nab-paclitaxel)
OT  - advanced gastric cancer
OT  - exploratory real-world study
OT  - oxaliplatin (LBP)
OT  - perioperative treatment
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at 
      https://jgo.amegroups.com/article/view/10.21037/jgo-23-131/coif). The authors 
      have no conflicts of interest to declare.
EDAT- 2023/05/18 19:12
MHDA- 2023/05/18 19:13
PMCR- 2023/04/29
CRDT- 2023/05/18 16:54
PHST- 2023/01/19 00:00 [received]
PHST- 2023/04/17 00:00 [accepted]
PHST- 2023/05/18 19:13 [medline]
PHST- 2023/05/18 19:12 [pubmed]
PHST- 2023/05/18 16:54 [entrez]
PHST- 2023/04/29 00:00 [pmc-release]
AID - jgo-14-02-1131 [pii]
AID - 10.21037/jgo-23-131 [doi]
PST - ppublish
SO  - J Gastrointest Oncol. 2023 Apr 29;14(2):1131-1140. doi: 10.21037/jgo-23-131. Epub 
      2023 Apr 27.