1.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
;
East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*
2.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
;
East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*
3.Implications, spiritual characteristics and practical significance of Chinese schistosomiasis control culture
Wei-Cheng DENG ; Yue-Sheng LI ; Xiang-Hui CHENG ; Guang-Hui REN ; Hong-Bin HE ; Yi-Biao ZHOU ; Yue-Yun ZHANG ; Ben-Jiao HU ; Han-Qiu LIU ; Shi-Kui LU ; Sheng-Ming LI ; Xiao-Nong ZHOU
Chinese Journal of Schistosomiasis Control 2020;32(3):222-224
The culture of schistosomiasis control is specific in the history of Chinese culture. Broadly speaking, the culture of schistosomiasis control is a summary of specific social mood, social consciousness and material culture created by Chinese populations during the progress of schistosomiasis control since the founding of the People’s Republic of China. Narrowly speaking, the culture of schistosomiasis control is the spiritual culture that is jointly created and nurtured by schistosomiasis control workers since the founding of the People’s Republic of China. The spiritual features of Chinese schistosomiasis control culture are characterized by the patriotism and care about the people, the matter-to-fact attitude, the pioneering and enterprising spirit, and the spirit of sacrifice and dedication. The ultimate goal of the research on the culture of schistosomiasis control is to facilitate the achievement of the strategic goal of Healthy China 2030 as scheduled, accelerate the progress towards elimination of schistosomiasis, and to promote the sustainable development of schistosomiasis control in China.
4.Challenges and countermeasures of schistosomiasis control in Hunan Province in the new era
Sheng-Ming LI ; Wei-Cheng DENG ; Xiang-Hui CHENG ; Hong-Bin HE ; Yi-Biao ZHOU ; Jie ZHOU ; Ben-Jiao HU ; Han-Qiu LIU ; Shi-Kui LU ; Yue-Sheng LI ; Xiao-Nong ZHOU ; Guang-Hui REN
Chinese Journal of Schistosomiasis Control 2020;32(3):225-229
This paper describes the current epidemic characteristics and endemic status of schistosomiasis, analyzes the main challenges of schistosomiasis control and proposes the emphasis and interventions for future schistosomiasis control activities in Hunan Province, so as to provide insights into the elimination of schistosomiasis in Hunan Province.
5.Effect of Arbuscular Mycorrhizal Fungi Inoculation on Physical and Chemical Properties of Rhizosphere Soil of Paris polyphylla var. yunnanensis
Ru-jie SHI ; Min YANG ; Dong-qin GUO ; Xing-jiao PAN ; Bo DING ; Jun-sheng QI ; Nong ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(22):77-85
Objective:To investigate the infection rate of
6.Effect of Different Arbuscular Mycorrhizal Fungi on Soil Nutrients in Rhizosphere Soil of Paris polyphylla var. yunnanensis Seedlings
Fu-rong ZHU ; Nong ZHOU ; Min YANG ; Bo DING ; Xing-jiao PAN ; Jun-sheng QI ; Dong-qin GUO
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(22):86-95
Objective:To clarify the effect of the arbuscular mycorrhizal (AM) fungi on the rhizosphere soil nutrient content,AM fungi infection rate and total rhizome saponins content of
7.Effect of Field Inoculation with Arbuscular Mycorrhizal Fungi on Rhizosphere Soil Structure of Paris polyphylla var. yunnanensis
Yan-ping HUANG ; Qiu-xia GAN ; Min YANG ; Jun-sheng QI ; Xing-jiao PAN ; Jie ZHANG ; Nong ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(22):110-115
Objective:To investigate the effects of arbuscular mycorrhiza(AM) fungi inoculation on the rhizosphere soil of
8.Effect of Different Arbuscular Mycorrhizal Fungi Combinations and Inoculation Periods on Rhizosphere Soil Physicochemical Properties and Microbial Quantity of Paris polyphylla var. yunnanensis Seedlings
Wen-chao GU ; Jie ZHANG ; Nong ZHOU ; Xing-jiao PAN ; Bo DING ; Jun-sheng QI ; Min YANG
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(22):116-130
Objective:To study the effects of different arbuscular mycorrhizal (AM) fungi combinations on rhizosphere soil physicochemical properties and microbial quantity in the seedlings of
9.Current status and transmission risks of oversea imported schistosomiasis in China
Jian-Feng ZHANG ; Li-Yong WEN ; Jing XU ; You-Sheng LIANG ; Xiao-Lan YAN ; Guang-Hui REN ; Tie-Wu JIA ; Wei WANG ; Xiao-Nong ZHOU
Chinese Journal of Schistosomiasis Control 2019;31(1):26-32
With the acceleration of the process of global integration, China’s international exchanges and cooperation with other countries have been further increased. The personnel exchange has led to the frequent occurrence of imported schistosomiasis from abroad, which seriously endangers people’s health. This paper reviews the prevalence and transmission risks of oversea imported schistosomiasis, providing the reference for the entry and exit health quarantine and prevention and control of schistosomiasis in China.
10.Study on the ARIMA model application to predict echinococcosis cases in China
En-Li TAN ; Zheng-Feng WANG ; Wen-Ce ZHOU ; Shi-Zhu LI ; Yan LU ; Lin AI ; Yu-Chun CAI ; Xue-Jiao TENG ; Shun-Xian ZHANG ; Zhi-Sheng DANG ; Chun-Li YANG ; Jia-Xu CHEN ; Wei HU ; Xiao-Nong ZHOU ; Li-Guang TIAN
Chinese Journal of Schistosomiasis Control 2018;30(1):47-53
Objective To predict the monthly reported echinococcosis cases in China with the autoregressive integrated mov-ing average(ARIMA)model,so as to provide a reference for prevention and control of echinococcosis. Methods SPSS 24.0 software was used to construct the ARIMA models based on the monthly reported echinococcosis cases of time series from 2007 to 2015 and 2007 to 2014,respectively,and the accuracies of the two ARIMA models were compared. Results The model based on the data of the monthly reported cases of echinococcosis in China from 2007 to 2015 was ARIMA(1,0,0)(1,1, 0)12,the relative error among reported cases and predicted cases was-13.97%,AR(1)=0.367(t=3.816,P<0.001),SAR (1)=-0.328(t=-3.361,P=0.001),and Ljung-Box Q=14.119(df=16,P=0.590).The model based on the data of the monthly reported cases of echinococcosis in China from 2007 to 2014 was ARIMA(1,0,0)(1,0,1)12,the relative error among reported cases and predicted cases was 0.56%,AR(1)=0.413(t=4.244,P<0.001),SAR(1)=0.809(t=9.584, P<0.001),SMA(1)=0.356(t=2.278,P=0.025),and Ljung-Box Q=18.924(df=15,P=0.217).Conclusions The different time series may have different ARIMA models as for the same infectious diseases.It is needed to be further verified that the more data are accumulated,the shorter time of predication is,and the smaller the average of the relative error is.The estab-lishment and prediction of an ARIMA model is a dynamic process that needs to be adjusted and optimized continuously accord-ing to the accumulated data,meantime,we should give full consideration to the intensity of the work related to infectious diseas-es reported(such as disease census and special investigation).

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