The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.

BACKGROUND:Studies have shown that cardiomyocyte apoptosis is closely related to cardiac decompensation and the cardiac aging process.Appropriate exercise can alter heart pump function in patients with heart failure as well as attenuate aging-induced cardiomyocyte apoptosis,hypertrophy,and fibrotic damage. OBJECTIVE:To investigate the effects of long-term aerobic exercise on cardiomyocyte apoptosis and the thioredoxin system in aging rats. METHODS:Thirty-six male Sprague-Dawley rats were selected and divided into three age groups:3-month-old young group,9-month-old middle-aged group,and 18-month-old elderly group,with 12 rats in each group.Within each age group,rats were randomly assigned to sedentary and exercise subgroups(n=6 per group).The sedentary groups did not undergo any exercise intervention.The exercise groups were acclimated to a treadmill environment and subsequently subjected to treadmill exercise for 45 minutes per day,at a speed of 15 m/min,5 days per week for 10 weeks in total.At 24 hours after the final intervention,ELISA was employed to measure serum levels of cardiac troponin I and creatine kinase-MB in rats.TUNEL assay was utilized to detect cardiomyocyte apoptosis,while western blot assay was employed to assess the protein expression of Bax,Bcl-2,Caspase 3,thioredoxin-1,thioredoxin-2,thioredoxin reductase-1,thioredoxin reductase-2,thioredoxin-interacting protein,apoptosis signal-regulating kinase 1,and P38 mitogen-activated protein kinase in rat myocardial tissue. RESULTS AND CONCLUSION:Serum levels of cardiac troponin I and creatine kinase-MB in the elderly sedentary group were significantly higher than those in the young and middle-aged sedentary groups and elderly exercise group(P<0.01).Serum levels of cardiac troponin I and creatine kinase-MB in the elderly sedentary group were significantly higher than those in the young and middle-aged exercise groups and elderly exercise group(P<0.01).Positive apoptotic cells in rat myocardial tissue,along with increased protein expression of Bax and Caspase 3,exhibited an age-related upward trend,while Bcl-2 protein expression showed a declining trend.In comparison with the sedentary groups within each age category,the number of apoptotic cardiomyocytes and the expression of Bax and Caspase 3 proteins were reduced to different degrees,and the expression of Bcl-2 protein was increased to different degrees in the corresponding exercise groups.Compared with the young sedentary group,middle-aged sedentary group and elderly exercise group,elderly sedentary rats showed a significant decrease in the expression of myocardial thioredoxin 1,thioredoxin 2,thioredoxin reductase 1,and thioredoxin reductase 2 proteins(P<0.05,P<0.01).The expression of myocardial thioredoxin 1,thioredoxin 2,and thioredoxin reductase 2 proteins was lower in the elderly exercise group than in the young exercise group(P<0.05,P<0.01),while the expression of thioredoxin reductase 1 and thioredoxin reductase 2 proteins was lower in the elderly exercise group than in the middle-aged exercise group(P<0.01).The protein expression of thioredoxin-interacting protein,apoptosis signal-regulating kinase 1,and P38 mitogen-activated protein kinase in rat myocardium was significantly higher in the elderly sedentary group than the young sedentary group,middle-aged sedentary group and elderly exercise group(P<0.01).The protein expression of thioredoxin-interacting protein,apoptosis signal-regulating kinase 1,and P38 mitogen-activated protein kinase in rat myocardium was significantly higher in the elderly exercise group than the young exercise group and middle-aged exercise group(P<0.01).To conclude,aerobic exercise may enhance the anti-apoptotic effects of thioredoxin by down-regulating the expression of thioredoxin-interacting protein in aging rat hearts,leading to the downregulation of apoptosis signal-regulated kinase 1 and P38 mitogen-activated kinase protein,thereby alleviating myocardial cell apoptosis in aging rat hearts.

OBJECTIVE To establish a GC-MS/MS analytical method for the determination of 1-chloroethyl cyclohexyl carbonate in candesartan cilexetil tablets. METHODS The analytical column was DB-5MS(30 m×0.25 mm, 0.25 μm). The column temperature was maintained at 80 ℃, then was raised to 300 ℃ at the rate of 20 ℃·min–1 and was maintained for 5 min. Helium was used as carrier gas, and its flow rate was 1.0 mL·min–1. The detection was achieved in multiple reaction monitoring mode. RESULTS The calibration curve of 1-chloroethyl cyclohexyl carbonate had good linearity in the concentration range of 4.4−437.8 ng·mL–1. The limits of quantification and detection were 4.4 and 2.2 ng·mL–1, respectively. The average recovery was 95.6%(RSD=6.3%, n=9). CONCLUSION This method has satisfactory convenience, good sensitivity and high accuracy, and it is suitable for the determination of 1-chloroethyl cyclohexyl carbonate in candesartan cilexetil tablets.

Objective:To investigate the levels of osteoporosis-related biomarkers in individuals with subclinical hypothyroidism complicated by type 2 diabetes mellitus.Methods:A cross-sectional study. From January 2021 to June 2022, 40 patients with subclinical hypothyroidism, 40 patients with type 2 diabetes, 40 patients with type 2 diabetes complicated with subclinical hypothyroidism, and 40 individuals receiving physical examination in Shanxi Bethune Hospital were selected as subjects in this study. The glucose and lipid metabolism indexes and bone metabolism indexes of the subjects were detected, and the differences and correlations of the metabolic indexes among the groups were analyzed by t-tests, nonparametric tests or correlation analysis. Results:Compared with healthy group, beta C-terminal cross-linked telopeptides of type Ⅰ collagen (β-CTX) level in type 2 diabetes group was higher [(344.60±125.61) vs (227.56±68.33) pg/ml] ( t=-5.176, P<0.001), osteocalcin (OC) and total procollagen type 1 aminoterminal peptide (t-PINP) were both lower [(15.76±4.70) vs (28.02±5.83)ng/ml, (43.49±13.63) vs (59.58±15.80) ng/ml] ( t=10.352, t=4.874, P<0.001). The β-CTX level in type 2 diabetes patients complicated with hypothyroidism was higher than that in patients with simple subclinical hypothyroidism [(380.51±122.22) vs (212.41±44.17) pg/ml] ( t=-8.180 ,P<0.001), but the levels of OC and t-PINP were both lower [(13.67±4.06) vs (26.12±4.55) ng/ml, (38.76±9.53) vs (61.50±12.31) ng/ml] ( t=12.897, P<0.001); but there was no significant difference in the three biomarkers between patients with type 2 diabetes mellitus complicated by subclinical hypothyroidism and those with type 2 diabetes mellitus alone. [β-CTX: (380.51±122.22) vs (344.60±125.61) pg/ml, OC: (13.67±4.06) vs (15.76±4.70) ng/ml, t-PINP: (38.76±9.53) vs (43.49±13.63) ng/ml] ( t=1.296,1.890,-1.799 ,all P>0.05). In the patients with type 2 diabetes mellitus complicated by subclinical hypothyroidism, the β-CTX was positively correlated with fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c)( r=0.293,0.487,all P<0.05), while OC and t-PINP were negatively correlated with FBG and HbA1c ( r=-0.560,-0.502,-0.289,-0.326, P<0.05). Conclusion:Changes of serum osteoporosis-related biomarkers in subclinical hypothyroidism patients with type 2 diabetes indicate the increased risk of osteoporosis in those patients.

Objective:To observe and verify the changes of transcriptome in hyperoxia-induced acute lung injury (HALI), and to further clarify the changes of pathways in HALI.Methods:Twelve healthy male C57BL/6J mice were randomly divided into normoxia group and HALI group according to the random number table, with 6 mice in each group. The mice in the normoxia group were fed normally in the room, and the mice in the HALI group was exposed to 95% oxygen to reproduce the HALI animal model. After 72 hours of hyperoxia exposure, the lung tissues were taken for transcriptome sequencing, and then Kyoto Encyclopedia of Genes and Genomes database (KEGG) pathway enrichment analysis was performed. The pathological changes of lung tissue were observed under light microscope after hematoxylin-eosin (HE) staining. Real-time fluorescence quantitative reverse transcription-polymerase chain reaction (RT-PCR) and Western blotting were used to verify the key molecules in the signal pathways closely related to HALI identified by transcriptomics analysis.Results:Transcriptomic analysis showed that hyperoxia induced 537 differentially expressed genes in lung tissue of mice as compared with the normoxia group including 239 up-regulated genes and 298 down-regulated genes. Further KEGG pathway enrichment analysis identified 20 most significantly enriched pathway entries, and the top three pathways were ferroptosis signaling pathway, p53 signaling pathway and glutathione (GSH) metabolism signaling pathway. The related genes in the ferroptosis signaling pathway included the up-regulated gene heme oxygenase-1 (HO-1) and the down-regulated gene solute carrier family 7 member 11 (SLC7A11). The related genes in the p53 signaling pathway included the up-regulated gene tumor suppressor gene p53 and the down-regulated gene murine double minute 2 (MDM2). The related gene in the GSH metabolic signaling pathway was up-regulated gene glutaredoxin 1 (Grx1). The light microscope showed that the pulmonary alveolar structure of the normoxia group was normal. In the HALI group, the pulmonary alveolar septum widened and thickened, and the alveolar cavity shrank or disappeared. RT-RCR and Western blotting confirmed that compared with the normoxia group, the mRNA and protein expressions of HO-1 and p53 in lung tissue of the HALI group were significantly increased [HO-1 mRNA (2 -ΔΔCt): 2.16±0.17 vs. 1.00±0.00, HO-1 protein (HO-1/β-actin): 1.05±0.01 vs. 0.79±0.01, p53 mRNA (2 -ΔΔCt): 2.52±0.13 vs. 1.00±0.00, p53 protein (p53/β-actin): 1.12±0.02 vs. 0.58±0.03, all P < 0.05], and the mRNA and protein expressions of Grx1, MDM2, SLC7A11 were significantly decreased [Grx1 mRNA (2 -ΔΔCt): 0.53±0.05 vs. 1.00±0.00, Grx1 protein (Grx1/β-actin): 0.54±0.03 vs. 0.93±0.01, MDM2 mRNA (2 -ΔΔCt): 0.48±0.03 vs. 1.00±0.00, MDM2 protein (MDM2/β-actin): 0.57±0.02 vs. 1.05±0.01, SLC7A11 mRNA (2 -ΔΔCt): 0.50±0.06 vs. 1.00±0.00, SLC7A11 protein (SLC7A11/β-actin): 0.72±0.03 vs. 0.98±0.01, all P < 0.05]. Conclusions:HALI is closely related to ferroptosis, p53 and GSH metabolism signaling pathways. Targeting the key targets in ferroptosis, p53 and GSH metabolism signaling pathways may be an important strategy for the prevention and treatment of HALI.

Objective:To compare the efficacy of Solution-focused brief therapy (SFBT) and the conventional care in the improvement of the prognosis and mental state of patients with chronic bone infection.Methods:A retrospective cohort study was conducted to analyze the clinical data of 219 patients with chronic bone infection who were admitted to the First Affiliated Hospital of the Army Medical University from January 2018 to February 2019, including 172 males and 47 females, aged 15-65 years [(42.1±3.8)years]. Infection sites were the tibia in 144 patients and the femur in 75 patients. According to the classification of Cierny-Mader bone infection, there were 44 patients with type I (intramedullary bone infection), 57 with type II (superficial bone infection), 79 with type III (local bone infection), and 39 with type IV (diffuse bone infection). The patients were divided into conventional care group (admitted from January to July 2018, n=106) and SFBT group (admitted from August 2018 to February 2019, n=113) according to their admission time. The conventional care group received the conventional care, while the SFBT group underwent SFBT on the basis of the conventional care, with an intervention period of 6 months. The Hospital for Special Surgery (HSS) knee score, 36-item Short Form Health Survey (SF-36) for somatic, emotional, role and social function, Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) were compared between the two groups before surgery, at discharge and at 6 months after surgery. The rates of satisfaction with the nursing care and bone healing were collected at the last follow-up. Results:All the patients were followed up for 12-36 months [(24.5±6.3)months]. The differences in HSS knee score, SF-36 for somatic, emotional, role, and social function scores, SAS score, and SDS score between the two groups were not statistically significant before surgery ( P>0.05). At discharge, the HSS knee score and SF-36 for somatic, emotional, role, and social function scores of the SFBT group were (68.6±6.9)points, (23.0±1.8)points, (23.2±1.6)points, (23.4±1.5)points, and (23.1±1.8)points respectively, which were all significantly higher than those of the conventional care group [(66.3±7.2)points, (19.7±3.3)points, (20.0±2.7)points, (19.8±3.2)points, and (20.5±2.7)points respectively] ( P<0.05); The SAS and SDS scores in the SFBT group were (40.9±6.2)points and (41.1±6.2)points respectively, which were both significantly lower than those in the conventional care group [(46.4±6.3)points and (47.3±6.4)points] ( P<0.05). At 6 months after surgery, the HSS knee score and SF-36 for somatic, emotional, role, and social function scores in the SFBT group were (81.6±6.7)points, (26.3±1.6)points, (27.9±1.4)points, (26.6±1.4)points, and (27.9±1.6)points respectively, which were all significantly higher than those in the conventional care group [(78.5±7.2)points, (17.4±2.9)points, (18.7±2.5)points, (18.3±3.0)points, and (20.0±2.5)points respectively] ( P<0.05 or 0.01); the SAS and SDS scores in the SFBT group were (32.8±4.8)points and (30.8±5.5)points respectively, which were significantly lower than those in the conventional care group [(44.2±5.5)points and (42.5±6.2)points] ( P<0.05). At the last follow-up in the conventional care group and the SFBT group, the rates of satisfaction with the nursing care were 66.0% (70/106) and 88.5% (100/113) respectively ( P<0.01), and the bone healing rates were 96.2% (102/106) and 94.7% (107/113) respectively ( P>0.05). Conclusion:Compared with the conventional care, SFBT for intervention to patients with chronic bone infection is a safe and effective mental nursing model which can improve the recovery of the function and the quality of the patients′ life, reduce their anxiety and depression, and enhance their satisfaction rate.

A portable washing device for eyes in on-site treatment was designed to be used in emergent event,so as to effectively respond to the needs of injury condition of on-site eye contamination,emergency rescue and other cure.The portable washing device for eyes designed in this study consists of an ophthalmic first-aid washing kit,an ocular electronic cleaning instrument and a washing needle for puncture in anterior chamber.The first-aid washing kit is equipped with a case and a protective cover,and the case is capable of storing spare first-aid medicines and instruments.It is possible to quickly check whether the medicines and instruments are all in readiness in the case through the transparently protective cover of the first-aid washing kit.The simple and convenient operation of this device can realize self-rescue operation of washing both eyes'conjunctival sacs at the same time by single person.This washing device not only can wash conjunctival sac on the contaminated ocular surface,but also can complete cleaning function for poison in the anterior chamber,and can real-timely monitor the acid-base value of the anterior chamber by using the measuring valve in the cavity of the ophthalmic electronic cleaning instrument.This washing device designed in this study is a highly practical toolkit specially designed for dealing with first-aid situations of eyes,which has many advantages include meeting the basic functions of emergency medical rescue for required nuclear and chemical injuries in daily training and support,emergency rescue and disaster relief,as well as defense and service support in wartime,and raising the emphasis of people to first-aid for eyes,and providing timely rescue for eyes.This device has a favorable value of conversion and promotion.

Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P＜0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.

Objective To investigate the relationship between serum solute carrier family 7 member 11(SLC7A11)and Janus kinase 2(JAK2)levels and the severity and prognosis of acute non-variceal upper gas-trointestinal bleeding(ANVUGIB).Methods A total of 108 patients with ANVUGIB who were treated in the hospital from April 2019 to April 2023 were selected and divided into severe group(31 cases),moderate group(44 cases)and mild group(33 cases)according to the severity of ANVUGIB.The patients were divided into poor prognosis group(41 cases)and good prognosis group(67 cases)according to their prognosis.An-other 50 healthy volunteers who underwent physical examination in the hospital during the same period were selected as the control group.Serum SLC7A11 and JAK2 levels were detected by enzyme-linked immunosor-bent assay.Spearman correlation analysis was used to analyze the correlation between serum SLC7A11 and JAK2 levels and Framingham risk score(FRS)and Glasweg-Blatchford bleeding score(GBS).Multivariate Logistic regression was used to analyze the influencing factors of poor prognosis in patients with ANVUGIB.Receiver operating characteristic(ROC)curve was used to analyze the predictive value of serum SLC7A11 and JAK2 for poor prognosis in patients with ANVUGIB.Results The serum SLC7A11 level was significantly lower and the serum JAK2 level was significantly higher in the three groups of ANVUGIB patients than in the control group(all P＜0.05).As the severity of the disease increased,the serum SLC7A11 level gradually de-creased,and the serum JAK2 level,FRS and GBS scores gradually increased(all P＜0.05).In ANVUGIB pa-tients,serum SLC7A11 level was negatively correlated with FRS and GBS scores,and serum JAK2 level was positively correlated with FRS and GBS scores(all P＜0.05).Compared with the good prognosis group,the poor prognosis group had significantly higher proportion of patients with bleeding volume＞400 mL,red blood cell distribution width,FRS score,GBS score,and JAK2 level,and significantly lower levels of hemoglo-bin and SLC7A11(P＜0.05).Bleeding volume＞400 mL and elevated JAK2 level were risk factors for poor prognosis in ANVUGIB patients,while elevated SLC7A11 level was a protective factor(all P＜0.05).The ar-ea under the curve of combined SLC7A11 and JAK2 in predicting poor prognosis of ANVUGIB patients was better than that of each index alone(Zcombination-SLC7A11=3.086,Zcombination JAK2=2.330,P=0.020,0.030).Conclu-sion The decrease of SLC7A11 level and increase of JAK2 level in patients with ANVUGIB can effectively e-valuate the severity and prognosis of patients,and the combination of the two can predict the prognosis of pa-tients with ANVUGIB.

Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P＜0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.