250 Background: Camrelizumab, a fully humanized monoclonal anti-PD-1 antibody, has shown promising efficacy with good tolerance in neoadjuvant therapy of resectable locally advanced esophageal cancer (EC). The present study aimed to investigate the effectiveness and safety of camrelizumab-based neoadjuvant therapy in a comparatively larger number of resectable EC patients in a real-world setting and initial results were reported here. Methods: In this prospective multicenter observational study (ChiCTR2000039170), patients with histologically confirmed resectable EC who were scheduled for camrelizumab-based neoadjuvant therapy at the discretion of treating physicians/ oncologists were included. Eligible patients were aged ≥ 18 years, had ECOG PS of 0-1, measurable disease per RECIST v1.1, adequate organ function, and expected survival time of ≥ 3 months, as well as provided written informed consent. The primary endpoint was safety. The secondary endpoints were major pathologic response (MPR), pathologic complete response (pCR), R0 resection rate, overall response rate (ORR), one-year overall survival (OS) rate, and disease-free survival (DFS). Results: At total of 166 patients (62.9 ± 9.2 years, and 84.2% male) were enrolled between October 20 2020 and August 26 2021. All patients received neoadjuvant camrelizumab plus chemotherapies (primarily nab-paclitaxel and nedaplatin) except one receiving camrelizumab alone. Overall, 109 patients (65.7%) experienced treatment-related adverse events (TRAEs), most commonly reactive cutaneous capillary endothelial proliferation (RCCEP, 45.3%), cough (10.4%), and pneumonia (8.5%). Thirteen (7.8%) patients experienced grade 3-4 TRAEs. There was no grade 5 toxicity. At the data cutoff, 141 (84.9%) patients were evaluable for radiological response, 82 (69.5%) patients underwent surgical resection. The ORR was 70.9% (100/141) and the R0 resection rate was 97.5% (79/82). Among the 81 patients available for pathologic assessment, 51 (63.0%) patients achieved MPR and of which, 15 (18.5%) had pCR. The median survival times have not been reached at the time of data analysis. Conclusions: The real-world data of our resectable EC patients showed effectiveness and safety profiles of camrelizumab-based neoadjuvant therapy consistent with those observed in previous trials.
The increasing application of aluminum alloy, in combination with the growth in the complexity of components, provides new challenges for the numerical modeling of sheet materials. The material elastic–plasticity constitutive model is the most important factor affecting the accuracy of finite element simulation. The mixed hardening constitutive model can more accurately represent the real hardening characteristics of the material plastic deformation process, and the accuracy of the material property-related parameters in the constitutive model directly affects the accuracy of finite element simulation. Based on the Hill48 anisotropic yield criterion, combined with the Voce isotropic hardening model and the Armstrong–Frederic nonlinear kinematic hardening model, a mixed hardening constitutive model that considers material anisotropy and the Bauschinger effect was established. Analysis of the tension–compression experiment on the sheet using finite element method. Using the finite element model, the optimum geometry of the tension–compression experiment sample was determined. The cyclic deformation stress–strain curve of the 2A11 aluminum alloy sheet was obtained by a cyclic tensile–compression test, and the material characteristic parameters in the mixed hardening model were accurately determined. The reliability and accuracy of the established constitutive model of anisotropic mixed hardening materials were verified by the finite element simulation and by testing the cyclic tensile–compression problem, the springback problem, and the sheet in bending, unloading, and reverse bending problems. The tensile–compression experiment is an effective method to directly and accurately obtain the characteristic parameters of constitutive model materials.
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