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Neoadjuvant camrelizumab and apatinib combined with chemotherapy versus chemotherapy alone for locally advanced gastric cancer: a multicenter randomized phase 2 trial.
Lin, Jian-Xian; Tang, Yi-Hui; Zheng, Hua-Long; Ye, Kai; Cai, Jian-Chun; Cai, Li-Sheng; Lin, Wei; Xie, Jian-Wei; Wang, Jia-Bin; Lu, Jun; Chen, Qi-Yue; Cao, Long-Long; Zheng, Chao-Hui; Li, Ping; Huang, Chang-Ming.
Afiliación
  • Lin JX; Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
  • Tang YH; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China.
  • Zheng HL; Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
  • Ye K; Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
  • Cai JC; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China.
  • Cai LS; Department of Gastrointestinal Surgery, Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.
  • Lin W; Department of Gastrointestinal Surgery, Zhongshan Hospital of Xiamen University, Xiamen, China.
  • Xie JW; Department of General Surgery, Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou, China.
  • Wang JB; Department of Gastrointestinal Surgery, The Affiliated Hospital of Putian University, Putian, China.
  • Lu J; Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
  • Chen QY; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China.
  • Cao LL; Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
  • Zheng CH; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China.
  • Li P; Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
  • Huang CM; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China.
Nat Commun ; 15(1): 41, 2024 01 02.
Article en En | MEDLINE | ID: mdl-38167806
ABSTRACT
Prospective evidence regarding the combination of programmed cell death (PD)-1 and angiogenesis inhibitors in treating locally advanced gastric cancer (LAGC) is limited. In this multicenter, randomized, phase 2 trial (NCT04195828), patients with gastric adenocarcinoma (clinical T2-4N + M0) were randomly assigned (11) to receive neoadjuvant camrelizumab and apatinib combined with nab-paclitaxel plus S-1 (CA-SAP) or chemotherapy SAP alone (SAP) for 3 cycles. The primary endpoint was the major pathological response (MPR), defined as <10% residual tumor cells in resection specimens. Secondary endpoints included R0 resection rate, radiologic response, safety, overall survival, and progression-free survival. The modified intention-to-treat population was analyzed (CA-SAP [n = 51] versus SAP [n = 53]). The trial has met pre-specified endpoints. CA-SAP was associated with a significantly higher MPR rate (33.3%) than SAP (17.0%, P = 0.044). The CA-SAP group had a significantly higher objective response rate (66.0% versus 43.4%, P = 0.017) and R0 resection rate (94.1% versus 81.1%, P = 0.042) than the SAP group. Nonsurgical grade 3-4 adverse events were observed in 17 patients (33.3%) in the CA-SAP group and 14 (26.4%) in the SAP group. Survival results were not reported due to immature data. Camrelizumab and apatinib combined with chemotherapy as a neoadjuvant regimen was tolerable and associated with favorable responses for LAGC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Gástricas / Neoplasias Primarias Secundarias Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Nat Commun Asunto de la revista: BIOLOGIA / CIENCIA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Gástricas / Neoplasias Primarias Secundarias Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Nat Commun Asunto de la revista: BIOLOGIA / CIENCIA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido