Study protocol of a phase II clinical trial evaluating the efficacy of neoadjuvant intraperitoneal and systemic albumin-bound paclitaxel combined with camrelizumab and S-1 in the treatment of patients with exfoliative cell-positive gastric cancer
oleh: Jingxia Lv, Jingxia Lv, Jiaxiang Wu, Jiaxiang Wu, Haotian Wu, Haotian Wu, Ping’an Ding, Ping’an Ding, Honghai Guo, Honghai Guo, Peigang Yang, Peigang Yang, Yuan Tian, Yuan Tian, Yang Liu, Yang Liu, Qun Zhao, Qun Zhao
| Format: | Article |
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| Diterbitkan: | Frontiers Media S.A. 2023-09-01 |
Deskripsi
BackgroundCurrently, gastric cancer with positive lavage cytology without gross peritoneal dissemination (GC-CY1) is a special type of metastatic form with poor prognosis. Consensus guidelines on treatment strategies for patients with GC-CY1 have not been established. This study involves a single-arm, prospective, phase II clinical trial to examine the efficacy and safety of neoadjuvant intraperitoneal and systemic (NIPS) albumin-bound paclitaxel combined with Camrelizumab and S-1 in the treatment of GC-CY1 patients.Methods/designThis is a prospective single-center exploratory study, and the primary endpoints of the trial are R0 resection rate and conversion rate of abdominal free cancer cells (FCCs), with secondary endpoints of 3-year progression-free survival (PFS); 3-year overall survival (OS); objective remission rate (ORR); disease control rate (DCR); safety and TRG classification.DiscussionThis study is the first to apply NIPS albumin-bound paclitaxel combined with Camrelizumab and S-1 to the conversion therapy of GC-CY1 patients. It is speculated that this combination of regimens will increase the negative conversion rate of FCCs by 20%, which will provide innovative insights into conversion treatment ideas for GC-CY1 patients to be managed in a more comprehensive and optimized manner.Clinical trial registrationhttp://clinicaltrials.gov/, identifier NCT05410847.