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Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study

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机构: [1]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy,Dept Radiat Oncol, Tianjin, Peoples R China [2]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Immunol & Biotherapy,Dept Immunol, Tianjin, Peoples R China [3]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Immunol & Biotherapy,Dept Nutr Thera, Tianjin, Peoples R China [4]Hebei Med Univ, Hebei Clin Res Ctr Radiat Oncol, Dept Radiotherapy, Hosp 4, Shijiazhuang, Hebei, Peoples R China [5]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy,Dept Pathol, Tianjin, Peoples R China [6]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy,Dept Endoscopy Dia, Tianjin, Peoples R China [7]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy,Dept Esophageal Ca, Tianjin, Peoples R China [8]Jiangsu Hengrui Pharmaceut Co Ltd, Lianyungang, Peoples R China
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关键词: Esophageal squamous cell carcinoma radiotherapy chemoradiotherapy immunotherapy PD-1 camrelizumab

摘要:
Patients with locally advanced esophageal squamous cell carcinoma (ESCC) show poor survival after concurrent chemoradiotherapy. This study investigated the safety and feasibility of combining concurrent chemoradiotherapy with the anti-PD-1 antibody camrelizumab as first-line treatment for these patients. In this phase 1b study (ClinicalTrials.gov NCT03671265), patients received concurrent chemotherapy (cisplatin [25 mg/m(2)] plus docetaxel [25 mg/m(2)] for 4 weeks) and radiotherapy (2.0 Gy/fraction, total 60 Gy) with camrelizumab (200 mg every 2 weeks for 32 weeks). Primary endpoints were safety and tolerability, and health-related quality of life. Secondary endpoints were radiological and pathological response rates, overall survival (OS), and progression-free survival (PFS). Candidate biomarkers in tumor and peripheral blood were monitored at baseline and after 40 Gy radiation. Twenty patients were enrolled. The most common treatment-related grade 3 adverse events included radiation esophagitis (20%) and esophageal fistula (10%). Serious treatment-related adverse events occurred in eight (40%) patients. No treatment-related deaths were reported. Health-related quality of life did not deteriorate. Thirteen (65%) patients had an objective response after 40 Gy radiation. At a median follow-up of 23.7 months (95% CI 21.9-24.5), OS and PFS time ranged from 8.2-28.5 and 4.0-28.5 months, respectively. The 12-month and 24-month OS rate was 85.0% and 69.6%; PFS rate was 80.0% and 65.0%. Tumor PD-L1 expression and CD11c(+) dendritic cells and peripheral-blood IL-27, IL-15, Eotaxin-3, and IL-22 were associated with OS. First-line concurrent chemoradiotherapy plus camrelizumab had a manageable safety profile and promising antitumour efficacy for ESCC, and deserves further study.

基金:

基金编号: number 81872462 81972772 82073348] and the Clinical Trial Supporting Foundation of Tianjin Medical University Cancer Institute & Hospital under Grant [number C1707

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出版当年[2021]版:
大类 | 2 区 医学
小类 | 2 区 免疫学 2 区 肿瘤学
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 免疫学 2 区 肿瘤学
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Q1 IMMUNOLOGY Q1 ONCOLOGY
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Q1 IMMUNOLOGY Q1 ONCOLOGY

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第一作者机构: [1]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy,Dept Radiat Oncol, Tianjin, Peoples R China
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通讯机构: [1]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy,Dept Radiat Oncol, Tianjin, Peoples R China [*1]Tianjin Med Univ Canc Inst & Hosp, Dept Radiat Oncol, Huanhuxi Rd, Huanhuxi 300060, Peoples R China
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