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. Prevalence of chronic diseases and associate factors on daily activities in male oldest-olds
Jiaqi LI ; Miao LIU ; Xianyu LYU ; Ru TANG ; Xue YANG ; Ming YIN ; Yao HE
Chinese Journal of Epidemiology 2019;40(5):537-541
Objective:
To investigate the prevalence of chronic diseases in aged ≥80 oldest-olds and related factors influencing their daily activities.
Methods:
This survey was conducted in the retired cadres in Beijing from 2012 to 2014. A unified questionnaire was used to investigate the general characteristics of the oldest-olds and the activities of daily living (ADL). Information on chronic diseases was extracted from related medical records.
Results:
A total of 4 472 male oldest- olds, with an average age as (87.1±3.9) years (80-102 years), were included. Nearly half of the elderly people were suffering from 5 or more kinds of chronic diseases, with 43.9% of them having disability on basic daily activities (BADL) with 13.4% of those classified as moderate or severe cases. 38.8% of them had instrumental activities of daily living (IADL) disability, with 28.7% of them were moderate or severe cases. The ADL disability showed an increasing trend along with the increase number of chronic diseases. The proportion of BADL disability increased from 40.5% to 50.6%. Compared with the ones having fewer chronic diseases (≤2 kinds), those with more (≥7 kinds) had an increase of 50.5% risk on BADL disability and 199.4% on IADL disability.
Conclusion
We noticed that the male oldest-olds suffered from multiple chronic diseases. The impairment of ADL was higher than the younger elderly. Comorbidity showed heavier impact on ADL, especially on the instrumental activities of daily living.
4.Analysis of Composition Principles of Prescriptions for Simple Obesity Based on Traditional Chinese Medicine Inheritance Support System
Huiyan ZENG ; Yingfu XIAO ; Jinming ZHANG ; Xianyu TANG ; Liu HE ; Qiting LIANG ; Jiali HE ; Lu SUN ; Wenwen XIE
Journal of Guangzhou University of Traditional Chinese Medicine 2017;34(4):612-616
Objective To explore the composition principles of prescriptions for simple obesity based on the analysis of medical literature issued in recently 30 years about Chinese medicine for simple obesity. Methods We collected literature of Chinese medicine in treating simple obesity from VIP, CNKI, Wanfang, CBM and CMCC/CMCI databases, and screened out the formulas for simple obesity to establish a formula database. And then the medication rules were figured out with the Traditional Chinese medicine Inheritance Support System version 2.5 (TCMISS 2.5) software. Results A total of 57 formulas were screened out. And the top 10 herbs with highest occurrence frequency in the prescriptions were Poria, Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis, Radix et Rhizoma Rhei, Fructus Crataegi, Radix Astragali, Radix Glycyrrhizae, Folium Nelumbinis, Pericarpium Citri Reticulatae and Semen Cassiae. After data mining, we got 13 high-frequency herb-pair combinations and 31 core combinations, and 8 new prescriptions were extracted. Conclusion The research has achieved the quantitative description of the relationship between the Chinese medicines, the extraction of the core combinations and the discovery of new Chinese medicine prescriptions for simple obesity. The results will provide references for the development of new Chinese medicines for the treatment of simple obesity .
5.Fiberoptic ductoscopy in 1,025 cases of nipple discharge.
Feng XU ; Zhonghua TANG ; Enxiang ZHOU ; Xianyu CHEN ; Wenjun YI ; Qingyun TANG ; Yongzhi PENG
Journal of Central South University(Medical Sciences) 2009;34(2):175-180
OBJECTIVE:
To assess the value of fiberoptic ductoscopy (FDS) in the diagnosis of nipple discharge.
METHODS:
Clinical records of 1,025 patients with nipple discharge undergoing FDS from February 2006 to March 2008 were reviewed.
RESULTS:
There were obviously differences in the FDS diagnosis of various nipple discharge traits. The diagnosis by FDS was pathologically confirmed in 93.7%of patients with nipple discharge (404/431).
CONCLUSION
FDS can effectively improve the diagnosis of nipple discharge,and has great clinical significance.
Adolescent
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Adult
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Aged
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Breast Diseases
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diagnosis
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pathology
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Breast Neoplasms
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diagnosis
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metabolism
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pathology
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Child
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Endoscopy
;
methods
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Female
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Fiber Optic Technology
;
methods
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Humans
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Male
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Middle Aged
;
Nipples
;
metabolism
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Papilloma, Intraductal
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diagnosis
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metabolism
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pathology
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Retrospective Studies
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Sensitivity and Specificity
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Young Adult
6.Clinical experience of Professor FAN Guan-jie in treating impaired glucose tolerance and newly diagnosed type 2 diabetes
Xianyu TANG ; Qiyun LU ; Xiaoze SUN
China Journal of Traditional Chinese Medicine and Pharmacy 2005;0(07):-
It summarized the differentiation and treatment ideas and experiences in using Chinese herbs of Prof.FAN in treating impaired glucose tolerance (IGT) and newly diagnosed type 2 diabetes mellitus (T2DM).Professor FAN creatively proposed the syndrome differentiation and treatment plans,which had the characteristics of combining movement with immobility,orderly and continuous,and the differentiation thinking of combing the characteristics with commonnesss.It had unique characteristics of using string of herbal drugs skillfully in clinical medication.

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