1.Analysis of the efficacy of lamb′s tripe extract and vitamin B 12 capsule on chronic atrophic gastritis at different sites
Dongdong XIA ; Huahong XIE ; Bo JIANG ; Hong XU ; Zhanguo NIE ; Chengwei TANG ; Qiang GUO ; Xiaoping ZOU ; Shuisheng SHI ; Tao SUN ; Shourong SHEN ; Guoqing LI ; Xiaozhong GUO ; Xiaoyan ZHAO ; Jiaming QIAN ; Weixing CHEN ; Guiying ZHANG ; Aijun LIAO ; Jingyuan FANG ; Daiming FAN ; Kaichun WU
Chinese Journal of Digestion 2025;45(3):162-168
Objective:To evaluate the efficacy of lamb′s tripe extract and vitamin B 12 capsule (LTEVB 12C) on chronic atrophic gastritis (CAG) at different locations (antrum lesser curvature, antrum greater curvature, gastric angle, corpus lesser curvature, and corpus greater curvature). Methods:From August 2011 to January 2013, 715 patients with CAG in a multicenter, randomized, double-blind, placebo-controlled trial were enrolled from 16 tertiary first-class hospitals across the country, including the First Affiliated Hospital of Air Force Medical University, Nanfang Hospital of Southern Medical University, the First Hospital of Jilin University, West China Hospital of Sichuan University, etc., there were 476 cases in the LTEVB 12C group and 239 cases in the placebo group. The patients of the LTEVB 12C group received LTEVB 12C, and the patients of placebo group received LTEVB 12C mimetic, all the medications were taken 3 capsules each time and 3 times a day after meals, and the treatment course of 2 groups were both 6 months. The efficacy evaluation criteria included the effective rate (a decrease of ≥1 in histopathological score compared with baseline after 6 months of treatment) and the reversal rate (a decrease of ≥ 2 in histopathological score compared with baseline after 6 months of treatment in the patients with moderate to severe CAG). The impact of lesion sites on the therapeutic effects of LTEVB 12C was analyzed by logistic regression analysis. The two-way unordered Cochran-Mantel-Haenszel chi-square test considering the center effect and Pearson chi-square test were used for statistical analysis. Results:The effective rates of chronic inflammation at the antrum greater curvature and corpus greater curvature (23.3%, 110/473 vs. 13.0%, 31/239; 20.3%, 96/472 vs. 12.6%, 30/239), the effective rates of atrophy at the antrum lesser curvature, antrum greater curvature, gastric angle, corpus lesser curvature, and the corpus greater curvature (27.0%, 118/437 vs. 15.7%, 34/216; 29.2%, 126/432 vs. 18.5%, 38/205; 27.8%, 121/435 vs. 16.7%, 36/216; 32.5%, 127/391 vs. 19.8%, 37/187; 33.0%, 119/361 vs. 21.8%, 39/179), and the effective rates of intestinal metaplasia at the antrum lesser curvature, antrum greater curvature, gastric angle, and the corpus lesser curvature (45.0%, 112/249 vs. 29.8%, 31/104; 53.8%, 86/160 vs. 33.9%, 21/62; 45.8%, 103/225 vs. 24.0%, 25/104; 51.9%, 83/160 vs. 28.3%, 17/60) of the LTEVB 12C group were all higher than those of the placebo group, and the differences were statistically significant ( χ2=10.76, 6.39, 9.69, 7.91, 11.05, 9.62, 8.57, 5.20, 7.11, 12.45, and 6.73; all P<0.05). The reversal rates of chronic inflammation at the corpus lesser curvature and corpus greater curvature (5.2%, 12/231 vs. 0, 0/123; 4.7%, 8/170 vs. 0, 0/88), the reversal rates of atrophy at the antrum lesser curvature, antrum greater curvature, corpus lesser curvature, and the corpus greater curvature (6.8%, 22/323 vs. 1.3%, 2/151; 9.2%, 29/315 vs. 1.4%, 2/144; 14.2%, 38/267 vs. 2.5%, 3/121; 20.8%, 35/168 vs. 5.8%, 4/69), and the reversal rates of intestinal metaplasia at the antrum lesser curvature, antrum greater curvature, gastric angle, and the corpus lesser curvature (29.8%, 39/131 vs. 9.1%, 4/44; 41.0%, 32/78 vs. 12.5%, 3/24; 33.3%, 44/132 vs. 4.8%, 3/63; 50.0%, 37/74 vs. 8.7%, 2/23) of the LTEVB 12C group were all higher than those of the placebo group, and the differences were statistically significant ( χ2=6.58, 5.12, 5.60, 8.61, 11.43, 6.59, 7.30, 4.95, 15.92, 7.62; all P<0.05). There were no statistically significant differences in the effective rates and reversal rates of active inflammation at different locations between the LTEVB 12C group and the placebo group (all P>0.05). The results of logistic regression analysis (taking the antrum lesser curvature as the reference) further confirmed that the reversal rates of chronic inflammation ( OR=0.22, 95% confidence interval (95% CI): 0.07 to 0.67; OR=0.24, 95% CI: 0.07 to 0.80), atrophy ( OR=0.28, 95% CI: 0.16 to 0.49; OR=0.28, 95% CI: 0.16 to 0.49), and intestinal metaplasia ( OR=0.42, 95% CI: 0.24 to 0.77; OR=0.20, 95% CI: 0.08 to 0.52) at the corpus lesser curvature and corpus greater curvature were all higher than those at the antrum lesser curvature, and the differences were statistically significant (all P<0.05). There were no statistically siginificant differences in the reversal rates of the aforementioned pathological features between the antrum greater curvature, gastric angle, and the antrum lesser curvature (all P>0.05). Conclusion:LTEVB 12C can achieve good efficacy in the treatment of CAG, and the chronic inflammation, atrophy, and intestinal metaplasia at multiple locations are improved, especially at the corpus lesser curvature and the corpus greater curvature.
2.Analysis of the efficacy of lamb′s tripe extract and vitamin B 12 capsule on chronic atrophic gastritis at different sites
Dongdong XIA ; Huahong XIE ; Bo JIANG ; Hong XU ; Zhanguo NIE ; Chengwei TANG ; Qiang GUO ; Xiaoping ZOU ; Shuisheng SHI ; Tao SUN ; Shourong SHEN ; Guoqing LI ; Xiaozhong GUO ; Xiaoyan ZHAO ; Jiaming QIAN ; Weixing CHEN ; Guiying ZHANG ; Aijun LIAO ; Jingyuan FANG ; Daiming FAN ; Kaichun WU
Chinese Journal of Digestion 2025;45(3):162-168
Objective:To evaluate the efficacy of lamb′s tripe extract and vitamin B 12 capsule (LTEVB 12C) on chronic atrophic gastritis (CAG) at different locations (antrum lesser curvature, antrum greater curvature, gastric angle, corpus lesser curvature, and corpus greater curvature). Methods:From August 2011 to January 2013, 715 patients with CAG in a multicenter, randomized, double-blind, placebo-controlled trial were enrolled from 16 tertiary first-class hospitals across the country, including the First Affiliated Hospital of Air Force Medical University, Nanfang Hospital of Southern Medical University, the First Hospital of Jilin University, West China Hospital of Sichuan University, etc., there were 476 cases in the LTEVB 12C group and 239 cases in the placebo group. The patients of the LTEVB 12C group received LTEVB 12C, and the patients of placebo group received LTEVB 12C mimetic, all the medications were taken 3 capsules each time and 3 times a day after meals, and the treatment course of 2 groups were both 6 months. The efficacy evaluation criteria included the effective rate (a decrease of ≥1 in histopathological score compared with baseline after 6 months of treatment) and the reversal rate (a decrease of ≥ 2 in histopathological score compared with baseline after 6 months of treatment in the patients with moderate to severe CAG). The impact of lesion sites on the therapeutic effects of LTEVB 12C was analyzed by logistic regression analysis. The two-way unordered Cochran-Mantel-Haenszel chi-square test considering the center effect and Pearson chi-square test were used for statistical analysis. Results:The effective rates of chronic inflammation at the antrum greater curvature and corpus greater curvature (23.3%, 110/473 vs. 13.0%, 31/239; 20.3%, 96/472 vs. 12.6%, 30/239), the effective rates of atrophy at the antrum lesser curvature, antrum greater curvature, gastric angle, corpus lesser curvature, and the corpus greater curvature (27.0%, 118/437 vs. 15.7%, 34/216; 29.2%, 126/432 vs. 18.5%, 38/205; 27.8%, 121/435 vs. 16.7%, 36/216; 32.5%, 127/391 vs. 19.8%, 37/187; 33.0%, 119/361 vs. 21.8%, 39/179), and the effective rates of intestinal metaplasia at the antrum lesser curvature, antrum greater curvature, gastric angle, and the corpus lesser curvature (45.0%, 112/249 vs. 29.8%, 31/104; 53.8%, 86/160 vs. 33.9%, 21/62; 45.8%, 103/225 vs. 24.0%, 25/104; 51.9%, 83/160 vs. 28.3%, 17/60) of the LTEVB 12C group were all higher than those of the placebo group, and the differences were statistically significant ( χ2=10.76, 6.39, 9.69, 7.91, 11.05, 9.62, 8.57, 5.20, 7.11, 12.45, and 6.73; all P<0.05). The reversal rates of chronic inflammation at the corpus lesser curvature and corpus greater curvature (5.2%, 12/231 vs. 0, 0/123; 4.7%, 8/170 vs. 0, 0/88), the reversal rates of atrophy at the antrum lesser curvature, antrum greater curvature, corpus lesser curvature, and the corpus greater curvature (6.8%, 22/323 vs. 1.3%, 2/151; 9.2%, 29/315 vs. 1.4%, 2/144; 14.2%, 38/267 vs. 2.5%, 3/121; 20.8%, 35/168 vs. 5.8%, 4/69), and the reversal rates of intestinal metaplasia at the antrum lesser curvature, antrum greater curvature, gastric angle, and the corpus lesser curvature (29.8%, 39/131 vs. 9.1%, 4/44; 41.0%, 32/78 vs. 12.5%, 3/24; 33.3%, 44/132 vs. 4.8%, 3/63; 50.0%, 37/74 vs. 8.7%, 2/23) of the LTEVB 12C group were all higher than those of the placebo group, and the differences were statistically significant ( χ2=6.58, 5.12, 5.60, 8.61, 11.43, 6.59, 7.30, 4.95, 15.92, 7.62; all P<0.05). There were no statistically significant differences in the effective rates and reversal rates of active inflammation at different locations between the LTEVB 12C group and the placebo group (all P>0.05). The results of logistic regression analysis (taking the antrum lesser curvature as the reference) further confirmed that the reversal rates of chronic inflammation ( OR=0.22, 95% confidence interval (95% CI): 0.07 to 0.67; OR=0.24, 95% CI: 0.07 to 0.80), atrophy ( OR=0.28, 95% CI: 0.16 to 0.49; OR=0.28, 95% CI: 0.16 to 0.49), and intestinal metaplasia ( OR=0.42, 95% CI: 0.24 to 0.77; OR=0.20, 95% CI: 0.08 to 0.52) at the corpus lesser curvature and corpus greater curvature were all higher than those at the antrum lesser curvature, and the differences were statistically significant (all P<0.05). There were no statistically siginificant differences in the reversal rates of the aforementioned pathological features between the antrum greater curvature, gastric angle, and the antrum lesser curvature (all P>0.05). Conclusion:LTEVB 12C can achieve good efficacy in the treatment of CAG, and the chronic inflammation, atrophy, and intestinal metaplasia at multiple locations are improved, especially at the corpus lesser curvature and the corpus greater curvature.
3.Clinical characteristics and outcomes of psoriasis patients with COVID-19: A retrospective, multicenter cohort study in China
Yanhua LIU ; Zhongrui XU ; Jian ZHOU ; Aijun CHEN ; Junling ZHANG ; Xiaojing KANG ; Xian JIANG ; Chengzhi LYU ; Chunrui SHI ; Yuling SHI ; Xiaoming LIU ; Fuqiu LI ; Bin YANG ; Yongmei HUANG ; Chen YU ; Gang WANG
Chinese Medical Journal 2024;137(14):1736-1743
Background::Limited information exists regarding the impact of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection on psoriasis patients. The objective of this study was to identify clinical factors associated with the prognosis of psoriasis following SARS-CoV-2 infection.Methods::A retrospective, multicenter study was conducted between March and May 2023. Univariable and multivariable logistic regression analyses were employed to identify factors associated with coronavirus disease 2019 (COVID-19)-related psoriasis outcomes. The study included 2371 psoriasis patients from 12 clinical centers, with 2049 of them having been infected with SARS-CoV-2.Results::Among the infected groups, lower exacerbation rates were observed in individuals treated with biologics compared to those receiving traditional systemic or nonsystemic treatments (22.3% [236/1058] vs. 39.8% [92/231] vs. 37.5% [140/373], P <0.001). Psoriasis progression with lesions (adjusted odds ratio [OR] = 8.197, 95% confidence interval [95% CI] = 5.685–11.820, compared to no lesions), hypertension (adjusted OR = 1.582, 95% CI = 1.068–2.343), traditional systemic (adjusted OR = 1.887, 95% CI= 1.263–2.818), and nonsystemic treatment (adjusted OR= 1.602, 95% CI= 1.117–2.297) were found to be associated with exacerbation of psoriasis after SARS-CoV-2 infection, but not biologics (adjusted OR = 0.931, 95% CI = 0.680–1.274, compared to no treatment), according to multivariable logistic regression analysis. Conclusions::A reduced risk of psoriasis exacerbation after SARS-CoV-2 infection was observed with biologics compared to traditional systemic and nonsystemic treatments. Significant risk factors for exacerbation after infection were identified as existing psoriatic lesions and hypertension.
4.Conditional screening of recombinant proteins of Dermacentor marginatus AQPs and anti-tick effect
Jun WU ; Wenwen HE ; Hao PU ; Min JIN ; Wenyu SHI ; Aijun MA ; Tingxiang LUO ; Depeng YANG ; Bayinchahan ; Ercha HU
Chinese Journal of Veterinary Science 2024;44(7):1466-1472,1506
In order to mine candidate vaccine antigens against ticks and to control ticks safely and effectively,the aim of this study was to immunize rabbits with purified aquaporins(AQPs)rD-mAQP1,rDmAQP2 and rDmAQP3 of Dermacentor marginatus.Blood collections for Western blot and ELISA tests were performed.The anti-tick challenge was conducted.The optimal expression conditions of rDmAQP1,rDmAQP2 and rDmAQP3 were screened by SDS-PAGE gel electrophore-sis.The three recombinant proteins were purified by HisSepNi-NTA6FF purification column.Rab-bits were divided into four groups of three rabbits each,including a control group and three immu-nized groups.The three purified recombinant proteins were separately immunized to three groups of rabbits,and the rabbits were immunized once on the 0th,14th and 21st day.Blood samples were collected every 7 days to prepare polyclonal antibodies.The reactivity was detected by Western blot and the antibody titer was detected by ELISA.Tick challenge test was carried out after the anti-body titer increased.The results showed that the optimal expression conditions for rDmAQP1 were induced for 8 h at IPTG concentration of 1.0 mmol/L and 37 ℃;the optimal expression conditions for rDmAQP2 were induced for 7 h at IPTG concentration of 1.0 mmol/L and 37 ℃;and the opti-mal expression conditions for rDmAQP3 were induced for 5 h at IPTG concentration of 1.0 mmol/L and 37 ℃.Western blot results showed that rDmAQP1,rDmAQP2 and rDmAQP3 all had certain reactivity.The ELISA results showed that the antibody titers of rabbits immunized with rD-mAQP1,rDmAQP2 and rDmAQP3 were as follows:the total anti-tick effect of rDmAQP1 protein was 79.74%,and the inhibition rates on average full-blooded tick weight,average egg weight and average egg hatching rate were 9.43%,25.17%and 63.81%,respectively.The total anti-tick effect of rDmAQP2 protein was 78.78%,and the inhibition rates of average full-blooded tick weight,av-erage egg weight and average egg hatching rate of Dermacentor marginatus were 8.30%,20.14%and 68.26%,respectively.The total anti-tick effect of rDmAQP3 protein was 87.91%,and the inhi-bition rates of average full-blooded tick weight,average egg weight and average egg hatching rate were 3.23%,22.47%and 80.5%,respectively.Through serological test and anti-tick test,it has been found that rDmAQP1,rDmAQP2 and rDmAQP3 all have the potential of candidate antigens against ticks,among which rDmAQP3 has the best immune effect,which lays a foundation for the study of the function of rDmAQP1,rDmAQP2 and rDmAQP3.
5.Study on the Predictive Value of Serum Hsa-miR-30c-5p Level Expression in Patients with Type 2 Diabetes Mellitus for Micro vascular Complications
Xiaoqin XIONG ; Xiaoyu FENG ; Aijun MAO ; Ding MA ; Yajun SHI
Journal of Modern Laboratory Medicine 2024;39(5):63-68
Objective To explore the predictive value of serum homo sapiens microRNA(hsa-miR)-30c-5p expression in patients with type 2 diabetes mellitus(T2DM)for microvascular complications.Methods A total of 205 T2DM patients admitted to Bazhong Central Hospital from May 2021 to September 2022 were selected as the diabetes group,and the diabetes group was further divided into diabetes with combined group(n=124)and non combined group(n=81)according to the microvascular complications of the patients.In addition,205 healthy people who underwent physical examination during the same period were selected as the control group.The expression of hsa-miR-30c-5p in serum was detected by reverse transcription-polymerase chain reaction(RT-PCR)and compared.The factors affecting microvascular complications were analyzed using multivariate logistic regression analysis,and receiver operating characteristic(ROC)curves were plotted to predict the value of serum hsa-miR-30c-5p expression in predicting microvascular complications in T2DM patients.Results The expression of serum hsa-miR-30c-5p in the combined group(0.58±0.06)and the non-combined group(0.72±0.08)were lower than that in the control group(0.89±0.21),and the differences were significant(t=16.038,7.079,all P=0.001).The combined group was lower than the non-combined group,and the difference was significant(t=14.289,P=0.001).The course of diabetes[(OR(95%CI):3.873(2.976~4.770)],uric acid[(OR(95%CI):2.125(1.211~3.040)]and glycosylated hemoglobin[(OR(95%CI):2.680(1.745~3.616)]were independent risk factors for microvascular complications in T2DM patients(all P<0.05),while the time within the target range of glucose[(OR(95%CI):0.491(0.135~0.846)]and serum hsa-miR-30c-5p[(OR(95%CI):0.532(2.976~4.770)]were protective factors for microvascular complications in T2DM patients(all P<0.05).The sensitivity,specificity and area under the curve(95%CI)of serum hsa-mir-30c-5p expression in predicting microvascular complications in T2DM patients were 81.45%,85.19%and 0.802(0.741~0.854),respectively.Conclusion The expression of serum hsa-miR-30c-5p in patients with T2DM is abnormally reduced,and serum hsa-miR-30c-5p is a protective factor for microvascular complications in patients with T2DM.It may have a certain predictive value for microvascular complications in patients with T2DM.
6.Research progress on the relationship between extracellular vesicles and male infertility
Cheng SHI ; Zewu LI ; Aijun YANG ; Yanan CHEN ; Yuting GU ; Lijun LIU
Clinical Medicine of China 2023;39(3):237-240
Infertility is gradually becoming a major problem affecting health worldwide, and male factors also play an important role in infertility. Extracellular vesicles (EVs) are ultramicro membranous vesicles released by cells during activation or apoptosis, which play an important role in cell communication. Relevant studies have shown that extracellular vesicles contain a variety of bioactive substances and participate in infertility related pathophysiological processes by influencing the content of intercellular transmission. Therefore, we reviewed the relationship between extracellular vesicles and male infertility, and expounded the occurrence and potential treatment of male infertility from another perspective.
7.Addendum: A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study
Tingyan SHI ; Libing XIANG ; Jianqing ZHU ; Jihong LIU ; Ping ZHANG ; Huaying WANG ; Yanling FENG ; Tao ZHU ; Yingli ZHANG ; Aijun YU ; Wei JIANG ; Xipeng WANG ; Yaping ZHU ; Sufang WU ; Yincheng TENG ; Jiejie ZHANG ; Rong JIANG ; Wei ZHANG ; Huixun JIA ; Rongyu ZANG
Journal of Gynecologic Oncology 2022;33(4):e63-
8.Development of practical liberal courses for students with non-biology majors under the "Double First-class" background.
Yingyi HUO ; Aijun HUANG ; Zhijian YANG ; Cheng XU ; Fan YANG ; Ying SHI ; Lei HE ; Guoqiang WANG ; Min WU
Chinese Journal of Biotechnology 2021;37(8):2976-2983
Life sciences are the disciplines most closely related with human beings. As experimental disciplines, life sciences develop rapidly and highly intersect in many scientific fields. Under the "double first-class" initiative, the comprehensive development-oriented talent training system has put forward an urgent need for life sciences literacy and comprehensive ability training of college students. Taking the reform of liberal education curriculum system as an opportunity, we developed a series of eight life sciences practical liberal courses for students with non-biology majors. The courses cover all sub-disciplines or directions of life sciences, and aim to foster interdisciplinary talents with life sciences knowledge and literacy, as well as practical and innovative abilities. These courses could serve as references for experimental teaching centers in colleges and universities to set up practical liberal and experimental courses.
Biological Science Disciplines
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Curriculum
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Humans
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Students
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Universities
9.Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial.
Dongsheng WANG ; Binqing FU ; Zhen PENG ; Dongliang YANG ; Mingfeng HAN ; Min LI ; Yun YANG ; Tianjun YANG ; Liangye SUN ; Wei LI ; Wei SHI ; Xin YAO ; Yan MA ; Fei XU ; Xiaojing WANG ; Jun CHEN ; Daqing XIA ; Yubei SUN ; Lin DONG ; Jumei WANG ; Xiaoyu ZHU ; Min ZHANG ; Yonggang ZHOU ; Aijun PAN ; Xiaowen HU ; Xiaodong MEI ; Haiming WEI ; Xiaoling XU
Frontiers of Medicine 2021;15(3):486-494
Tocilizumab has been reported to attenuate the "cytokine storm" in COVID-19 patients. We attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and inflammation biomarkers were observed. Thirty-three patients were randomized to the tocilizumab group, and 32 patients to the control group. The cure rate in the tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI-7.19%-21.23%, P = 0.4133). The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12 (P = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the hypoxia ameliorated earlier after tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI-99.17% to-17.50%, P = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%). Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated IL-6 levels, tocilizumab could be recommended to improve outcome.
Antibodies, Monoclonal, Humanized
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COVID-19/drug therapy*
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Humans
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SARS-CoV-2
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Treatment Outcome
10.A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study
Tingyan SHI ; Sheng YIN ; Jianqing ZHU ; Ping ZHANG ; Jihong LIU ; Libing XIANG ; Yaping ZHU ; Sufang WU ; Xiaojun CHEN ; Xipeng WANG ; Yincheng TENG ; Tao ZHU ; Aijun YU ; Yingli ZHANG ; Yanling FENG ; He HUANG ; Wei BAO ; Yanli LI ; Wei JIANG ; Ping ZHANG ; Jiarui LI ; Zhihong AI ; Wei ZHANG ; Huixun JIA ; Yuqin ZHANG ; Rong JIANG ; Jiejie ZHANG ; Wen GAO ; Yuting LUAN ; Rongyu ZANG
Journal of Gynecologic Oncology 2020;31(3):e61-
Background:
In China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence.
Methods
SOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography–computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cyclesof platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate.

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