1.Preoperative short-course radiotherapy followed by chemotherapy and PD-1 inhibitor administration for locally advanced rectal cancer: the initial results of a randomized controlled clinical trial (STELLAR II)
Haoyue LI ; Haitao ZHOU ; Lichun WEI ; Yinggang CHEN ; Wenjue ZHANG ; Feiyan DENG ; Ning LI ; Zheng JIANG ; Zheng LIU ; Jianwei LIANG ; Zhaoxu ZHENG ; Xianyu MENG ; Yufei LU ; Zifa LEI ; Xiaoge SUN ; Gong LI ; Yingjie WANG ; Yongwen SONG ; Shunan QI ; Hao JING ; Yirui ZHAI ; Shulian WANG ; Yexiong LI ; Yuan TANG ; Jing JIN
Chinese Journal of Oncology 2025;47(9):913-921
Objectives:To explore whether short-course radiotherapy (SCRT)-based total neoadjuvant therapy (TNT) combined with PD-1 inhibitors could further promote tumor regression and improve the prognosis.Methods:This is a prospective, multicenter, two-arm randomized controlled, seamless phase Ⅱ/Ⅲ trial for proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC). Eligible patients were randomly assigned to the iTNT (TNT+PD-1) group or the TNT group. Patients in the TNT group received SCRT (5 Gy×5) followed by 4 cycles of CAPOX or 6 cycles of mFOLFOX chemotherapy, with the iTNT group receiving SCRT followed by the same regime in combination with 4 cycles of Sintilimab. Total mesorectal excision (TME) surgery or watch and wait (W&W) was performed after neoadjuvant therapy and then 2 cycles of same regimen as before were recommended. The primary endpoints are the complete response (CR) rate for phase Ⅱ trial and 3-year disease-free survival (DFS) for phase Ⅲ trial. A total of 588 patients will be enrolled for the phase Ⅱ/Ⅲ trial. Short-term efficacy and safety data from the initial 100 treated patients were analyzed as planned.Results:From 2022-8-31 to 2023-5-24 the initial 100 patients were enrolled from 10 hospitals in China, 76.0%(76/100) patients were male, and the median age was 61 years (21-74 years). More patients had tumors located in the lower rectum (78.0%, 78/100), staged T3-4 (97.0%, 97/100) and N1-2 (93.0%, 93/100), and about half of the tumors invaded the mesorectal fascia (52.0%, 52/100) and with extramural vascular invasion (51.0%, 51/100). Analyses were performed according to the per-protocal (PP) set. All patients in the iTNT group ( n=52) and the TNT group ( n=48) completed SCRT; The 4-cycle chemotherapy±Sintilimab completion rates were 86.5% and 100.0% in the iTNT and TNT groups, respectively. In the iTNT group, 82.7% (43/52), 11.5% (6/52), and 5.8% (3/52) of the patients received 4, 3, and 2 cycles of PD-1 inhibitor. After TNT, 68 patients underwent radical surgery and 15 patients achieved cCR and adopted W&W. The pathological complete response (pCR) rates were 48.5% (16/33) and 17.1% (6/35) in the iTNT and TNT groups, with CR rates of 50.0% (25/50) and 26.1% (12/46), respectively. The incidence of treatment-related grade 3-4 adverse events was 26.9% (14/52, iTNT group) and 18.8% (9/48, TNT group), with thrombocytopenia and leukopenia being the most common. Among patients receiving immunotherapy, grade 3 immunotherapy-related adverse events occurred in 2 (3.8%, 2/52) patients: one case was pancreatitis, another case was hepatitis combined with myositis and myocarditis. Conclusion:The preliminary results show that SCRT-based TNT combined with PD-1 inhibitors could further improve the CR rate for LARC without unexpected serious adverse events.
2.Preoperative short-course radiotherapy followed by chemotherapy and PD-1 inhibitor administration for locally advanced rectal cancer: the initial results of a randomized controlled clinical trial (STELLAR II)
Haoyue LI ; Haitao ZHOU ; Lichun WEI ; Yinggang CHEN ; Wenjue ZHANG ; Feiyan DENG ; Ning LI ; Zheng JIANG ; Zheng LIU ; Jianwei LIANG ; Zhaoxu ZHENG ; Xianyu MENG ; Yufei LU ; Zifa LEI ; Xiaoge SUN ; Gong LI ; Yingjie WANG ; Yongwen SONG ; Shunan QI ; Hao JING ; Yirui ZHAI ; Shulian WANG ; Yexiong LI ; Yuan TANG ; Jing JIN
Chinese Journal of Oncology 2025;47(9):913-921
Objectives:To explore whether short-course radiotherapy (SCRT)-based total neoadjuvant therapy (TNT) combined with PD-1 inhibitors could further promote tumor regression and improve the prognosis.Methods:This is a prospective, multicenter, two-arm randomized controlled, seamless phase Ⅱ/Ⅲ trial for proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC). Eligible patients were randomly assigned to the iTNT (TNT+PD-1) group or the TNT group. Patients in the TNT group received SCRT (5 Gy×5) followed by 4 cycles of CAPOX or 6 cycles of mFOLFOX chemotherapy, with the iTNT group receiving SCRT followed by the same regime in combination with 4 cycles of Sintilimab. Total mesorectal excision (TME) surgery or watch and wait (W&W) was performed after neoadjuvant therapy and then 2 cycles of same regimen as before were recommended. The primary endpoints are the complete response (CR) rate for phase Ⅱ trial and 3-year disease-free survival (DFS) for phase Ⅲ trial. A total of 588 patients will be enrolled for the phase Ⅱ/Ⅲ trial. Short-term efficacy and safety data from the initial 100 treated patients were analyzed as planned.Results:From 2022-8-31 to 2023-5-24 the initial 100 patients were enrolled from 10 hospitals in China, 76.0%(76/100) patients were male, and the median age was 61 years (21-74 years). More patients had tumors located in the lower rectum (78.0%, 78/100), staged T3-4 (97.0%, 97/100) and N1-2 (93.0%, 93/100), and about half of the tumors invaded the mesorectal fascia (52.0%, 52/100) and with extramural vascular invasion (51.0%, 51/100). Analyses were performed according to the per-protocal (PP) set. All patients in the iTNT group ( n=52) and the TNT group ( n=48) completed SCRT; The 4-cycle chemotherapy±Sintilimab completion rates were 86.5% and 100.0% in the iTNT and TNT groups, respectively. In the iTNT group, 82.7% (43/52), 11.5% (6/52), and 5.8% (3/52) of the patients received 4, 3, and 2 cycles of PD-1 inhibitor. After TNT, 68 patients underwent radical surgery and 15 patients achieved cCR and adopted W&W. The pathological complete response (pCR) rates were 48.5% (16/33) and 17.1% (6/35) in the iTNT and TNT groups, with CR rates of 50.0% (25/50) and 26.1% (12/46), respectively. The incidence of treatment-related grade 3-4 adverse events was 26.9% (14/52, iTNT group) and 18.8% (9/48, TNT group), with thrombocytopenia and leukopenia being the most common. Among patients receiving immunotherapy, grade 3 immunotherapy-related adverse events occurred in 2 (3.8%, 2/52) patients: one case was pancreatitis, another case was hepatitis combined with myositis and myocarditis. Conclusion:The preliminary results show that SCRT-based TNT combined with PD-1 inhibitors could further improve the CR rate for LARC without unexpected serious adverse events.
3.Clinical research of determination of infection status of children with lower respiratory infection according to sputum properties and the accuracy of the choice of antibiotics
Zhongxia LI ; Jianyu RAN ; Feiyan LIANG ; Hua HUANG ; Chi LIANG ; Dejun LI
Chinese Journal of Primary Medicine and Pharmacy 2020;27(8):927-931
Objective:To explore the accuracy of determination of the pathogen in children with lower respiratory infection according to sputum properties and the selection of corresponding antibiotics.To analyze the relationship between children's age, length of hospital stays and sputum culture positive rate.Methods:From March 2015 to November 2016, 300 children with lower respiratory infection in the Seventh Affiliated Hospital of Guangxi Medical University were selected.The isolated sputums through the nasal cavity were cultured, the sputum properties and antibiotics used at the beginning and 3-4 days later(after sputum culture) were recorded.Results:The sputum culture showed that 110 of 300 cases with lower respiratory infection were positive.Main pathogens were streptococcus pneumoniae, E.coli, staphylococcus aureus, klebsiella pneumoniae subspecies.Compared with the children with positive sputum culture, for white phlegm sputum and yellow phlegm sputum, the children with sputum culture negative had higher accuracy of antibiotic use(white phlegm sputum: 64.4%, yellow phlegm sputum: 57.1%), the difference was statistically significant (χ 2=36.04, P<0.01). The bacteria positive rate and multiple resistance rate had no statistically significant differences in length of treatment time prior to admission(all P>0.05). However, the bacteria positive rate (hospital stay ≤7 d: 24.7%, hospital stay>7 d: 48.1%, χ 2=17.66) and multiple resistance rate (hospital stay≤7 d: 13.9%, hospital stay>7 d: 35.1%; χ 2=5.40) had statistically significant differences in the length of hospitalization(all P<0.05). The bacteria positive rates in different age groups were as follows: 1-6 months: 48.1%, >6-36 months: 28.3%, >36 months: 25.0%.Compared with the two others, the positive rate of 1-6 months was higher and had statistically significant difference (χ 2=13.64, P<0.05). Conclusion:Accuracy of antibiotics use has a certain relationship with sputum color or properties and the result of sputum culture, for white phlegm sputum and yellow phlegm sputum, the accuracy of antibiotics use is higher.Once identified pathogen, sensitive antibiotics should be adopted.Probably, bacteria positive rate and multiple resistance rate have a certain relationship with the length of hospital stay and age.
4.An XcmⅠ-generated T vector and its applications in synthetic biology.
Yangkai DUAN ; Feiyan LIANG ; Xiaoming TAN ; Xuefeng LV
Chinese Journal of Biotechnology 2016;32(7):956-965
For more economical and efficient DNA clonging, pFL-XS-T, a Biobrick-T vector was constructed based on pMD18-T vector, carrying clonging regions of XbaⅠ-XcmⅠ-XcmⅠ-SpeⅠ. The results revealed that PCR products could be conveniently inserted into pFL-XS-T vevtor digested by XcmⅠby means of TA cloning. The positive frequency of recombination can meet the experimental requirements and all the plasmids obtained meet Biobrick standard. Moreover, the pFL-XS-T is compatible with other Biobrick parts, and serves as a vector for functional DNA fragments screening.
Cloning, Molecular
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DNA
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Genetic Vectors
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Plasmids
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Polymerase Chain Reaction
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Synthetic Biology
5.Effects of simulated training for on-the-job physicians' electrocardiogram theory and operational learning effect
Junqiang FENG ; Liang ZHU ; Xiaolin NIU ; Qi AN ; Le ZOU ; Feiyan MA
Chinese Journal of Medical Education Research 2014;13(11):1174-1177
Objective To evaluate the effect of simulated training on in-service physicians electrocardiogram(ecg) theory and operational learning effect.Methods Sixty resident doctors were randomly divided into experiment group (n=30) and control group(n=30).The experimental group adopted teaching + simulation training mode to implement the theory and operation of ECG in continuing while the control group were taught only by lectures.Training effect of both groups was assessed by electrocardiogram theory and operation examination before and after training respectively,and by questionnaires at the end of the training as well.Data of the examination and questionnaires were analyzed by t test or x2 test.P<0.05 was considered statistically significant.Results After training,the score of theory examination was (90.87 ± 6.67) points in experiment group and was (85.83 ± 5.5) points in control group,with statistical difference between these two groups(t=3.201,P=0.003).Score of operation examination was(93.40 ± 4.31) points in experiment group and was(77.03 ± 7.96)points in control group,with significant differences(t=10.204,P=0.000).The satisfaction degree of enhancing learning interest,theoretical knowledge and operation skill,and strengthening the concept of humauistic care were significantly better in the experiment group than in the control group (x2=34.737,6.405,42.088,41.713,P=0.000,0.011,0.000,0.000).Conclusions Application of simulated training in the study of electrocardiogram is obviously superior in effect to the traditional teaching model.It can improve the theoretical knowledge and operation skill,which is helpful in elevating the in-service physicians' comprehensive capability.
6.Simultaneous determination of six flavonoids in Apocynum venetum by HPLC.
Qunlin ZHANG ; Liang WU ; Anding YAN ; Feiyan HU ; Ye YUAN ; Juncheng WANG
China Journal of Chinese Materia Medica 2011;36(5):589-593
OBJECTIVETo develop a high-performance liquid chromatography (HPLC) method for the simultaneous determination of rutin, hyperoside, isoquercetin, astragulin, quercetin, and kaempferol in Apocynum venetum and its extracts.
METHODThe separation was carried out on a Shim pack ODS (4.6 mm x 250 mm, 5 microm) colum eluted with in mobile phases of water containing 0.2% phosphoric acid and acetonitrile containing 0.2% phosphoric acid in acetonitrile gradient mode. The column temperature was 40 degrees C, and the flow rate was 1.0 mL x min(-1). The detection wavelength was set at 360 nm.
RESULTThe good seperation of six flavonoids was achieved within 40 min, with the relative standard deviations (RSD) of intra- and inter-day precision < or = 2.0%. Calibration curves of rutin, hyperoside, isoquercetin, astragulin, quercetin, and kaempferol showed good linear relationship (R2 > 0.999 7, n = 6). The average recoveries of the six flavonoids were within 97.30% - 105.8% (RSD 2.6%). Three batches of A. venetum and 2 batches of its extracts were determined.
CONCLUSIONThe developed method is simple, accurate, and repeatable, and can be readily used as a powerful tool for the quality control of A. venetum and its extracts.
Apocynum ; chemistry ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; chemistry ; Flavonoids ; analysis ; Quality Control ; Reproducibility of Results

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