Open AccessEfficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial
Author(s) -
Jia Wei,
Xiaofeng Lu,
Qin Liu,
Yao Fu,
Song Liu,
Lin Li,
Fangcen Liu,
Xiangshan Fan,
Ju Yang,
Yang Yang,
Yang Zhao,
Wenxian Guan,
Baorui Liu
Publication year - 2022
Publication title -
cancer management and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.024
H-Index - 40
ISSN - 1179-1322
DOI - 10.2147/cmar.s355687
Subject(s) - medicine , clinical endpoint , oncology , chemoradiotherapy , cancer , response evaluation criteria in solid tumors , adenocarcinoma , surrogate endpoint , clinical trial , chemotherapy , phases of clinical research , gastroenterology , surgery
Concurrent chemoradiotherapy (cCRT) is the mainstay therapy of locally advanced gastric (G) and gastroesophageal junction (GEJ) cancers with a poor prognosis. Programmed cell death receptor-1 (PD-1) inhibitor has been approved and recommended to treat ≥3 line G/GEJ patients. A significant clinical benefit of PD-1 inhibitors in addition to cCRT has been observed in locally advanced lung cancer. Sintilimab, a humanized IgG4 monoclonal antibody with high affinity and specificity for PD-1, has shown promising efficacy with an overall response rate of 85% in combination with chemotherapy in gastric cancer in a phase Ib study (NCT02937116).