1.Efficacy and safety of transarterial chemoembolization combined with sintilimab and bevacizumab biosimilar for unresectable hepatocellular carcinoma
Hao YANG ; Jintao HUANG ; Di HU ; Binyan ZHONG ; Jian SHEN ; Xiaoli ZHU
Chinese Journal of Internal Medicine 2025;64(2):134-141
Objective:To investigate the efficacy and safety of transarterial chemoembolization (TACE) combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular careinoma (uHCC).Methods:The clinical data of 64 patients with unresectable HCC, who were admitted to the First Affiliated Hospital of Soochow University between January 2021 and December 2023, were retrospectively analyzed. The patients were divided into a combination group ( n=43, receiving TACE combined with sintilimab and bevacizumab biosimilar) and control group ( n=21, receiving only sintilimab and bevacizumab biosimilar). Survival curves were drawn by Kaplan-Meier method, and the median overall survival (mOS) and median progression-free survival (mPFS) were compared between the two groups. According to the mRECIST criterion, the objective response rate (ORR) and disease control rate (DCR) were compared between the two groups. The occurrences of adverse events in both groups were recorded. Results:The mOS and mPFS in the combination group were 22.3 months and 12.4 months, respectively, which in the control group was 11.6 months and 6.4 months, respectively. The differences between the two groups were statistically significant ( P=0.001 and P=0.002). The ORR and DCR in the combination group were 62.8% and 95.3% respectively, which were significantly higher than 19.0% and 57.1% respectively in the control group (all P<0.01). No statistically significant difference in the incidence of severe adverse events existed between the two groups ( P=0.518). Conclusion:TACE combined with sintilimab and bevacizumab biosimilar has efficacy and safety than sintilimab and bevacizumab biosimilar alone.
2.Efficacy and safety of transarterial chemoembolization combined with sintilimab and bevacizumab biosimilar for unresectable hepatocellular carcinoma
Hao YANG ; Jintao HUANG ; Di HU ; Binyan ZHONG ; Jian SHEN ; Xiaoli ZHU
Chinese Journal of Internal Medicine 2025;64(2):134-141
Objective:To investigate the efficacy and safety of transarterial chemoembolization (TACE) combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular careinoma (uHCC).Methods:The clinical data of 64 patients with unresectable HCC, who were admitted to the First Affiliated Hospital of Soochow University between January 2021 and December 2023, were retrospectively analyzed. The patients were divided into a combination group ( n=43, receiving TACE combined with sintilimab and bevacizumab biosimilar) and control group ( n=21, receiving only sintilimab and bevacizumab biosimilar). Survival curves were drawn by Kaplan-Meier method, and the median overall survival (mOS) and median progression-free survival (mPFS) were compared between the two groups. According to the mRECIST criterion, the objective response rate (ORR) and disease control rate (DCR) were compared between the two groups. The occurrences of adverse events in both groups were recorded. Results:The mOS and mPFS in the combination group were 22.3 months and 12.4 months, respectively, which in the control group was 11.6 months and 6.4 months, respectively. The differences between the two groups were statistically significant ( P=0.001 and P=0.002). The ORR and DCR in the combination group were 62.8% and 95.3% respectively, which were significantly higher than 19.0% and 57.1% respectively in the control group (all P<0.01). No statistically significant difference in the incidence of severe adverse events existed between the two groups ( P=0.518). Conclusion:TACE combined with sintilimab and bevacizumab biosimilar has efficacy and safety than sintilimab and bevacizumab biosimilar alone.
3.Advances in the diagnosis and treatment of intrahepatic cholangiocarcinoma
Di HU ; Jintao HUANG ; Binyan ZHONG ; Jian SHEN ; Xiaoli ZHU
Journal of Clinical Hepatology 2024;40(7):1470-1476
Intrahepatic cholangiocarcinoma(ICC)is a relatively rare type of primary liver cancer,and its incidence rate has gradually increased in recent years.Due to its insidious onset and atypical clinical symptoms,most patients are already in the advanced stage of the disease at the time of confirmed diagnosis,and therefore,timely diagnosis and treatment are of great importance.Radical surgical resection is the standard treatment regimen for early-stage ICC patients,while systemic chemotherapy is the basic treatment for patients with advanced ICC and is often combined with interventional treatment,targeted therapy,and immunotherapy.This article reviews the advances in the diagnosis and treatment of ICC.
4.Efficacy and safety of tyrosine kinase inhibitor combined with immune checkpoint inhibitor as the second-line therapy for advanced hepatocellular carcinoma
Hong NIE ; Binyan ZHONG ; Jian SHEN ; Xiaoli ZHU
Journal of Clinical Hepatology 2024;40(8):1620-1626
Objective To investigate the efficacy and safety of tyrosine kinase inhibitor(TKI)combined with immune checkpoint inhibitor as the second-line therapy for advanced hepatocellular carcinoma(HCC).Methods A retrospective analysis was performed for the clinical data of 63 patients with advanced HCC who were admitted to Department of Interventional Radiology,The First Affiliated Hospital of Soochow University,from January 2018 to December 2022,and all patients experienced progression/intolerance after transcatheter arterial chemoembolization combined with first-line TKI and were switched to second-line TKI with or without immune checkpoint inhibitor.The 32 patients receiving second-line TKI with immune checkpoint inhibitor were enrolled as combination group,and the 31 patients receiving second-line TKI alone were enrolled as single treatment group.Modified Response Evaluation Criteria in Solid Tumors was used to evaluate tumor response,and Common Terminology Criteria for Adverse Events 5.0 was used to evaluate adverse events.The Kaplan-Meier method was used to calculate median overall survival(mOS)and median progression-free survival(mPFS)for the two groups,and the two groups were compared in terms of objective response rate(ORR)and disease control rate(DCR).The chi-square test was used for comparison of baseline data and follow-up results between groups.Results The median follow-up time was 16.5(3.2-53.4)months for the 63 patients.The combination group had an mOS of 24.3(95%confidence interval[CI]:20.0-28.6)months and an mPFS of 9.8(95%CI:7.5-12.1)months,while the single treatment group had an mOS of 15.8(95%CI:11.4-20.1)months and an mPFS of 4.1(95%CI:3.2-4.9)months,and there were significant differences in mOS and mPFS between the two groups(P=0.029 and 0.038).The combination group had an ORR of 47%and a DCR of 84%,while the single treatment group had an ORR of 19%and a DCR of 65%;there was a significant difference in ORR between the two groups(P=0.021),but with no significant difference in DCR between the two groups(P=0.070).As for adverse events,4 patients(12.5%)in the combination group and 3(10.0%)in the single treatment group experienced grade Ⅲ-Ⅳ serious adverse events,with no fatal drug reactions in either group,and there was no significant difference in the incidence rate of adverse events between the two groups(P=0.783).Conclusion Compared with TKI alone,TKI combined with immune checkpoint inhibitor has a more significant therapeutic effect as the second-line therapy for advanced HCC,without increasing serious adverse reactions.
5.Value of modified albumin-bilirubin grade in predicting the prognosis of patients with Child-Pugh class A unresectable hepatocellular carcinoma after transcatheter arterial chemoembolization combined with immunotherapy and anti-angiogenic drugs
Jiaqing LI ; Xiaoyang XU ; Zexin HU ; Shen ZHANG ; Binyan ZHONG ; Xiaoli ZHU
Journal of Clinical Hepatology 2024;40(12):2450-2456
ObjectiveTo investigate the ability of the modified albumin-bilirubin (mALBI) grade in predicting the prognosis of patients with Child-Pugh A unresectable hepatocellular carcinoma (uHCC) after transcatheter arterial chemoembolization (TACE) combined with immunotherapy and anti-angiogenic drugs (hereafter referred to as targeted immunotherapy). MethodsA retrospective analysis was performed for the data of 76 patients with Child-Pugh A uHCC who met the inclusion criteria and underwent TACE combined with targeted immunotherapy in The First Affiliated Hospital of Soochow University from January 2020 to January 2023, and according to the mALBI grade, they were divided into mALBI 1/2a group with 38 patients and mALBI 2b group with 38 patients. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Evaluation criteria included complete remission, partial remission, stable disease, and progressive disease. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between groups; the chi-square test was used for comparison of categorical variables between two groups. The Kaplan-Meier method was used to plot survival curves, and the Log-rank test was used for comparison of median OS (mOS) and median PFS (mPFS) between groups. The univariate and multivariate Cox proportional hazards models were used to analyze the influencing factors for prognosis. ResultsThere were significant differences in albumin and tumor burden between the two groups (both P<0.05). The 76 patients had an mOS of 25.2 months (95% confidence interval [CI]: 18.4 — 32.0), an mPFS of 9.4 months (95%CI: 7.1 — 11.7), an ORR of 63.2%, and a DCR of 82.9%. The mOS was 30.1 months (95%CI: 19.8 — 40.4) in the mALBI 1/2a group and 19.5 months (95%CI: 7.1 — 31.9) in the mALBI 2b group, and there was a significant difference in mOS between the two groups (χ2=4.490, P=0.034). The mALBI 1/2a group had an mPFS of 10.2 months (95%CI: 8.4 — 12.0), an ORR of 71.1%, and a DCR of 86.8%, while the mALBI 2b group had an mPFS of 7.6 months (95%CI: 4.6 — 10.6), an ORR of 55.3%, and a DCR of 78.9%; there were no significant differences in mPFS, ORR, and DCR between the two groups (all P>0.05). ECOG status, tumor burden, mALBI grade, portal vein invasion, and extrahepatic metastasis were independent risk factors for mOS in patients undergoing TACE combined with targeted immunotherapy (all P<0.05). There were no treatment-related deaths. ConclusionThe mALBI grade has a good value in predicting the survival of patients with Child-Pugh A uHCC undergoing TACE combined with targeted immunotherapy.
6.Treatment of Fournier's gangrene with "firebreak" drainage based on skin preservation
Xiaorui YE ; Heiying JIN ; Jun WANG ; Chunxia ZHANG ; Yang YANG ; Jiabo GU ; Xinyi ZHANG ; Jianlei LIU ; Binyan SHEN
Chinese Journal of Gastrointestinal Surgery 2024;27(7):726-730
Objective:To observe the clinical efficacy of a new type of "firebreak" drainage with skin preservation in the treatment of Fournier's gangrene.Methods:This technique is suitable for patients with perianal necrotizing fasciitis who can tolerate surgery without large area of skin blackness and necrosis. Procedure and key points: (1) The dividing line between inflammatory tissue and normal tissue was determined according to imaging examination and intraoperative exploration; (2) The abscess cavity was cut along the most obvious part of the abscess fluctuation, with a long diameter of 3~4 cm and a short diameter of 1~2 cm; (3) Necrotic tissue was discreetly separated and removed from the main incision to the outer edge of the infection. A fusiform incision was made every 3 to 5 cm, with a long diameter of 2 to 3 cm and a short diameter of 1 cm, and discreetly separated until the normal tissue, and a hose was hung between the adjacent incisions for drainage. (4) Each adjacent edge cut between the stealth separation and hanging hose drainage, forming a "firebreak"; (5) Rinse the wound repeatedly; (6) If the infection invades the rectum, colostomy is performed as required. The case data of 11 patients with perianal necrotizing fasciitis admitted to the Second Affiliated Hospital of Nanjing University of Chinese Medicine from July 2019 to February 2023 were retrospectively analyzed. All patients were treated with emergency surgical debridement by "firebreak" drainage with skin preservation.Results:All 11 cases were cured with 100%. One case underwent multiple operations. The hospitalization time was 11-46 days, with an average of 22 days. The wound healing time was 28-75 days, with an average of 43 days. Except for 1 patient with trauma, all the other patients had no significant anal function injury after surgery. All the 11 patients recovered and were discharged from hospital with a median follow-up of 136 (115-413) days.Conclusions:The "firebreak" drainage based on skin preservation has the advantages of less trauma and faster recovery, and do not cause obvious anal function damage.
7.Efficacy and safety of transcatheter arterial chemoembolization combined with targeted therapy and immunotherapy in treatment of patients with stage Ⅱb/Ⅲa hepatocellular carcinoma based on China Liver Cancer Staging
Zexin HU ; Jiaqing LI ; Wanci LI ; Binyan ZHONG ; Shuai ZHANG ; Jian SHEN ; Xiaoli ZHU
Journal of Clinical Hepatology 2024;40(3):550-555
ObjectiveTo evaluate the efficacy and safety of first-line transcatheter arterial chemoembolization (TACE) combined with targeted therapy and immunotherapy in the treatment of patients with stage Ⅱb/Ⅲa hepatocellular carcinoma (HCC) based on China Liver Cancer Staging (CNLC). MethodsA total of 198 patients who received first-line TACE combined with targeted therapy and immunotherapy or received TACE alone from January 2015 to December 2022 in the First Affiliated Hospital of Soochow University were enrolled in this study, and after propensity score matching, there were 50 patients in combination group and 50 patients in TACE group. The Kaplan-Meier method was used to calculate median overall survival (mOS) and median progression-free survival (mPFS). Modified Response Evaluation Criteria in Solid Tumors was used to evaluate objective response rate (ORR) and disease control rate (DCR), and Common Terminology Criteria for Adverse Events v5.0 was used to evaluate adverse events. The chi-square test was used for comparison of categorical data between two groups; the t-test was used for comparison of normally distributed continuous data between two groups, and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between two groups. The Kaplan-Meier method was used to estimate survival time and calculate 95% confidence interval (CI), and the Log-rank test was used for comparison of mOS and mPFS between two groups. ResultsThe combination group had an mOS of 30.1 months (95%CI: 21.9 — 38.3), and the TACE group had an mOS of 14.5 months (95%CI: 11.0 — 18.0), with a significant difference between the two groups (χ2=17.8, P<0.001); the combination group had an mPFS of 10.3 months (95%CI: 8.8 — 11.8), and the TACE group had an mPFS of 7.1 months (95%CI: 5.8 — 8.4), with a significant difference between the two groups (χ2=10.4, P<0.001). There were significant differences between the combination group and the TACE group in ORR (84% vs 58%, P<0.05) and DCR (94% vs 80%, P<0.05). There was no significant difference between the combination group and the TACE group in the incidence rate of adverse events (24% vs 16%, P=0.317), and no adverse event-related deaths were observed in either group. ConclusionCompared with TACE alone, TACE combined with targeted therapy and immunotherapy has a better efficacy in the treatment of patients with CNLC stage Ⅱb/Ⅲa HCC, without increasing the incidence rate of severe adverse events.
8.Treatment of Fournier's gangrene with "firebreak" drainage based on skin preservation
Xiaorui YE ; Heiying JIN ; Jun WANG ; Chunxia ZHANG ; Yang YANG ; Jiabo GU ; Xinyi ZHANG ; Jianlei LIU ; Binyan SHEN
Chinese Journal of Gastrointestinal Surgery 2024;27(7):726-730
Objective:To observe the clinical efficacy of a new type of "firebreak" drainage with skin preservation in the treatment of Fournier's gangrene.Methods:This technique is suitable for patients with perianal necrotizing fasciitis who can tolerate surgery without large area of skin blackness and necrosis. Procedure and key points: (1) The dividing line between inflammatory tissue and normal tissue was determined according to imaging examination and intraoperative exploration; (2) The abscess cavity was cut along the most obvious part of the abscess fluctuation, with a long diameter of 3~4 cm and a short diameter of 1~2 cm; (3) Necrotic tissue was discreetly separated and removed from the main incision to the outer edge of the infection. A fusiform incision was made every 3 to 5 cm, with a long diameter of 2 to 3 cm and a short diameter of 1 cm, and discreetly separated until the normal tissue, and a hose was hung between the adjacent incisions for drainage. (4) Each adjacent edge cut between the stealth separation and hanging hose drainage, forming a "firebreak"; (5) Rinse the wound repeatedly; (6) If the infection invades the rectum, colostomy is performed as required. The case data of 11 patients with perianal necrotizing fasciitis admitted to the Second Affiliated Hospital of Nanjing University of Chinese Medicine from July 2019 to February 2023 were retrospectively analyzed. All patients were treated with emergency surgical debridement by "firebreak" drainage with skin preservation.Results:All 11 cases were cured with 100%. One case underwent multiple operations. The hospitalization time was 11-46 days, with an average of 22 days. The wound healing time was 28-75 days, with an average of 43 days. Except for 1 patient with trauma, all the other patients had no significant anal function injury after surgery. All the 11 patients recovered and were discharged from hospital with a median follow-up of 136 (115-413) days.Conclusions:The "firebreak" drainage based on skin preservation has the advantages of less trauma and faster recovery, and do not cause obvious anal function damage.
9.Current status and prospects of transarterial chemoembolization and its combined regimens in the treatment of hepatocellular carcinoma
Zexin HU ; Jintao HUANG ; Binyan ZHONG ; Jian SHEN ; Xiaoli ZHU
Journal of Clinical Hepatology 2024;40(1):175-180
Transarterial chemoembolization (TACE) is currently the primary treatment method for advanced liver cancer. This article elaborates on the current status of application of TACE in hepatocellular carcinoma from the aspects of existing techniques, patient selection, and efficacy assessment and summarizes the research advances and prospects of TACE combined with local treatment and systemic therapy, so as to provide new ideas for clinical practice and experimental studies.
10.Clinical application of early transjugular intrahepatic portosystemic shunt and related and research advances
Ze WANG ; Jintao HUANG ; Binyan ZHONG ; Jian SHEN ; Xiaoli ZHU
Journal of Clinical Hepatology 2023;39(7):1513-1522
Transjugular intrahepatic portosystemic shunt (TIPS) is a procedure to establish a portosystemic shunt between the hepatic vein and the portal vein via the jugular approach, so as to reduce portal venous pressure and control acute esophagogastric variceal bleeding (EGVB). The prognosis of EGVB has been improved significantly over the past few decades, and endoscopic variceal ligation combined with drug therapy is now recommended as the first-line treatment regimen for this disease. The latest research advances in the management of EGVB over the past decade have focused on the relatively new concept of "early" or "pre-emptive" TIPS, that is to say, early TIPS (within 72 hours after admission, ideally within 24 hours) is recommended for patients with EGVB who are at a relatively high risk of failure in standard treatment. This article briefly introduces the effect of early TIPS on controlling bleeding, mortality rate, and hepatic encephalopathy, the high-risk population for early TIPS, timing of intervention, cost effectiveness, the applications of early TIPS in a real-world setting, and recommendations for early TIPS in international guidelines and consensus statements.

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