1.Efficacy and safety of bronchial arterial chemoembolization combined with tislelizumab for advanced non-small cell lung cancer
Chao LIANG ; Hao LI ; Daqian HAN ; Jiacheng WANG ; Wenze XU ; Manzhou WANG ; Donglin KUANG ; Jianzhuang REN ; Xinwei HAN ; Xuhua DUAN
Journal of Interventional Radiology 2025;34(2):148-153
Objective To assess the efficacy and safety of bronchial arterial chemoembolization(BACE)combined with tislelizumab for advanced non-small cell lung cancer(NSCLC).Methods A total of 30 patients in First Affiliated Hospital of Zhengzhou University with stage Ⅲ-Ⅳ NSCLC from December 2021 to August 2022 were enrolled in this study.All the patients received BACE,which was followed by 200 mg tislelizumab once every 3 weeks until the disease progressed,or the patient developed intolerable adverse effects,or the investigator decided to terminate this drug treatment.The primary study endpoint was progression-free survival(PFS),and the secondary study endpoints included overall survival(OS),objective response rate(ORR),disease control rate(DCR),safety,and quality of life(QoL).Results The median follow-up time was 12 months(range of 1.5-12 months),the median PFS was 10.5 months(95%CI:7.8-13.2 months),and the median OS was not available.The 3-month,6-month,and 12-month ORRs were 63.3%(95%CI:43.9%-80.1%),56.7%(95%CI:37.4%-74.5%),and 30.4%(95%CI:13.2%-52.9%)respectively.The 3-month,6-month,and 12-month DCRs were 80%(95%CI:61.4%-92.3%),76.7%(95%CI:57.7%-90.1%),and 47.8%(95%CI:26.8%-69.4%)respectively.The expression ratio of PD-L1 ≥50%(HR=0.29,P=0.039),tumor having a single feeding artery(HR=0.35,P=0.028),and completion of>10 cycles of tislelizumab therapy(HR=0.42,P=0.064)were the protective factors for PFS.No ≥grade Ⅲ treatment-related adverse events(TRAEs)occurred.The common below grade Ⅱ TRAEs were nausea,fever,and cough.After one cycle of treatment,the patient's QoL,including overall quality of life,physical functioning,and emotional functioning,was significantly improved.Conclusion For the treatment of patients with advanced NSCLC,BACE plus tislelizumab has satisfactory clinical efficacy and safety.
2.Safety and efficacy analysis of TACE combined with donafenib and PD-1 inhibitors in the treatment of unresectable hepatocellular carcinoma
Daqian HAN ; Wenze XU ; Chao LIANG ; Hao LI ; Shuguang JU ; Manzhou WANG ; Jiacheng WANG ; Yang-yang NIU ; Xinwei HAN ; Jianzhuang REN ; Xuhua DUAN
Chinese Journal of Hepatobiliary Surgery 2025;31(7):503-509
Objective:To compare the safety and efficacy of transarterial chemoembolization (TACE) combined with donafenib and programmed death protein 1 (PD-1) inhibitors and TACE combined with donafenib in the treatment of unresectable hepatocellular carcinoma (uHCC).Methods:Clinical data of 148 patients with uHCC treated at the First Affiliated Hospital of Zhengzhou University from December 2021 to December 2022 were retrospectively analyzed, including 127 males and 21 females, aged (56.6±9.9) years. Patients were divided into two groups: the TACE combined with donafenib and PD-1 inhibitors group (TACE+ DP, n=73) and TACE combined with single donafenib (TACE+ D, n=75). The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and the occurrence of treatment-related adverse events (TRAEs) of the two groups of patients were observed. Kaplan-Meier analysis was used for survival assessment, and the log-rank test was used for comparison. The related factors affecting the prognosis of patients were indentified and analyzed. Results:The median PFS of patients in the TACE+ D group and the TACE+ DP group were 7.2 months (95% CI: 5.7-8.3 months) and 10.5months (95% CI: 8.9-11.3 months), respectively. The median OS was 13.2 months (95% CI: 12.3-13.7 months) and 16.9 months (95% CI: 15.1-19.8 months), respectively. All these differences were statistically significant ( χ2=17.81, 26.92, respectively, both P<0.001). The ORR and DCR of TACE+ DP group were both higher than those in TACE+ D group [53.4% (39/73) vs 36.0% (27/75), χ2=4.55, P=0.031; and 90.4% (66/73) vs 77.3% (58/75), χ2=4.66, P=0.044]. No grade 4 or above adverse events occurred in either the TACE+ DP or the TACE+ D group. The most common treatment-related adverse events in TACE+ D and TACE+ DP group were hand-foot syndrome [46.7% (35/75) vs 49.3% (36/73)], hypertension [26.7% (20/75) vs 30.1% (22/73)], fatigue [22.7% (17/75) vs 24.7% (18/73)], diarrhea [26.7% (20/75) vs 28.8% (21/73)], and thrombocytopenia [25.3% (19/75) vs 28.8% (21/73)]. There was no significant difference in the incidence and severity of TRAEs between the groups ( χ2=0.08, P=0.774). TACE+ DP treatment was a favorable prognostic factor for PFS ( HR=0.33, 95% CI: 0.22-0.49, P<0.001) and OS ( HR=0.19, 95% CI: 0.11-0.33, P<0.001) of patients. Conclusion:Compared to TACE combined with donafenib, TACE combined with donafenib and PD-1 inhibitors, with good efficacy and safety, significantly improved the treatment response and survival in patients with uHCC.
3.Clinical study of TACE combined with apatinib for advanced hilar cholangiocarcinoma
Daqian HAN ; Hao LI ; Chao LIANG ; Manzhou WANG ; Yangyang NIU ; Shuguang JU ; Jiacheng WANG ; Jianzhuang REN ; Xinwei HAN ; Xuhua DUAN
Chinese Journal of Hepatobiliary Surgery 2025;31(4):262-267
Objective:To study the safety and feasibility of transcatheter arterial chemoembolization (TACE) combined with apatinib in the treatment of advanced hilar cholangiocarcinoma.Methods:Clinical data of 41 patients with hilar cholangiocarcinoma admitted to the First Affiliated Hospital of Zhengzhou University from November 2019 to October 2020 were prospectively collected, including 21 males and 20 females, aged (65.1±12.5) years. The drugs used for TACE were albumin paclitaxel and gemcitabine, which were performed once every four to six weeks for no more than six times. Apatinib were adminstered two days after each TACE. The primary endpoint was objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS) and adverse events. Patients were followed-up by outpatient, inpatient or telephone review. Survival analysis was performed using the Kaplan-Meier method.Results:Hilar cholangiocarcinoma were confirmed in all 41 patients by pathology. All patients were treated with TACE for at least twice. Twenty-three patients achieved complete remission, 14 stable disease, and four partial remission, with an ORR of 56.1% and a disease control rate of 90.2%. The follow-up duration was (13.3±5.4) months without lost to follow-up. The median PFS was 9.0 months, the median OS was 14.0 months, the 1-year cumulative recurrence-free survival rate was 31.7%, and the 1-year cumulative survival rate was 65.9%. Treatment-related adverse events in this study were predominantly Clavien-Dindo grade 1 or 2, without grade 4 to 5.Conclusion:TACE combined with apatinib treatment could be safe and feasible for advanced hilar cholangiocarcinoma.
4.Safety and efficacy analysis of TACE combined with donafenib and PD-1 inhibitors in the treatment of unresectable hepatocellular carcinoma
Daqian HAN ; Wenze XU ; Chao LIANG ; Hao LI ; Shuguang JU ; Manzhou WANG ; Jiacheng WANG ; Yang-yang NIU ; Xinwei HAN ; Jianzhuang REN ; Xuhua DUAN
Chinese Journal of Hepatobiliary Surgery 2025;31(7):503-509
Objective:To compare the safety and efficacy of transarterial chemoembolization (TACE) combined with donafenib and programmed death protein 1 (PD-1) inhibitors and TACE combined with donafenib in the treatment of unresectable hepatocellular carcinoma (uHCC).Methods:Clinical data of 148 patients with uHCC treated at the First Affiliated Hospital of Zhengzhou University from December 2021 to December 2022 were retrospectively analyzed, including 127 males and 21 females, aged (56.6±9.9) years. Patients were divided into two groups: the TACE combined with donafenib and PD-1 inhibitors group (TACE+ DP, n=73) and TACE combined with single donafenib (TACE+ D, n=75). The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and the occurrence of treatment-related adverse events (TRAEs) of the two groups of patients were observed. Kaplan-Meier analysis was used for survival assessment, and the log-rank test was used for comparison. The related factors affecting the prognosis of patients were indentified and analyzed. Results:The median PFS of patients in the TACE+ D group and the TACE+ DP group were 7.2 months (95% CI: 5.7-8.3 months) and 10.5months (95% CI: 8.9-11.3 months), respectively. The median OS was 13.2 months (95% CI: 12.3-13.7 months) and 16.9 months (95% CI: 15.1-19.8 months), respectively. All these differences were statistically significant ( χ2=17.81, 26.92, respectively, both P<0.001). The ORR and DCR of TACE+ DP group were both higher than those in TACE+ D group [53.4% (39/73) vs 36.0% (27/75), χ2=4.55, P=0.031; and 90.4% (66/73) vs 77.3% (58/75), χ2=4.66, P=0.044]. No grade 4 or above adverse events occurred in either the TACE+ DP or the TACE+ D group. The most common treatment-related adverse events in TACE+ D and TACE+ DP group were hand-foot syndrome [46.7% (35/75) vs 49.3% (36/73)], hypertension [26.7% (20/75) vs 30.1% (22/73)], fatigue [22.7% (17/75) vs 24.7% (18/73)], diarrhea [26.7% (20/75) vs 28.8% (21/73)], and thrombocytopenia [25.3% (19/75) vs 28.8% (21/73)]. There was no significant difference in the incidence and severity of TRAEs between the groups ( χ2=0.08, P=0.774). TACE+ DP treatment was a favorable prognostic factor for PFS ( HR=0.33, 95% CI: 0.22-0.49, P<0.001) and OS ( HR=0.19, 95% CI: 0.11-0.33, P<0.001) of patients. Conclusion:Compared to TACE combined with donafenib, TACE combined with donafenib and PD-1 inhibitors, with good efficacy and safety, significantly improved the treatment response and survival in patients with uHCC.
5.Clinical study of TACE combined with apatinib for advanced hilar cholangiocarcinoma
Daqian HAN ; Hao LI ; Chao LIANG ; Manzhou WANG ; Yangyang NIU ; Shuguang JU ; Jiacheng WANG ; Jianzhuang REN ; Xinwei HAN ; Xuhua DUAN
Chinese Journal of Hepatobiliary Surgery 2025;31(4):262-267
Objective:To study the safety and feasibility of transcatheter arterial chemoembolization (TACE) combined with apatinib in the treatment of advanced hilar cholangiocarcinoma.Methods:Clinical data of 41 patients with hilar cholangiocarcinoma admitted to the First Affiliated Hospital of Zhengzhou University from November 2019 to October 2020 were prospectively collected, including 21 males and 20 females, aged (65.1±12.5) years. The drugs used for TACE were albumin paclitaxel and gemcitabine, which were performed once every four to six weeks for no more than six times. Apatinib were adminstered two days after each TACE. The primary endpoint was objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS) and adverse events. Patients were followed-up by outpatient, inpatient or telephone review. Survival analysis was performed using the Kaplan-Meier method.Results:Hilar cholangiocarcinoma were confirmed in all 41 patients by pathology. All patients were treated with TACE for at least twice. Twenty-three patients achieved complete remission, 14 stable disease, and four partial remission, with an ORR of 56.1% and a disease control rate of 90.2%. The follow-up duration was (13.3±5.4) months without lost to follow-up. The median PFS was 9.0 months, the median OS was 14.0 months, the 1-year cumulative recurrence-free survival rate was 31.7%, and the 1-year cumulative survival rate was 65.9%. Treatment-related adverse events in this study were predominantly Clavien-Dindo grade 1 or 2, without grade 4 to 5.Conclusion:TACE combined with apatinib treatment could be safe and feasible for advanced hilar cholangiocarcinoma.
6.Effect of TACE with drug-loaded microspheres versus with iodinated oil emulsion on liver fibrosis
Daqian HAN ; Hao LI ; Manzhou WANG ; Chao LIANG ; Jiacheng WANG ; Wenze XU ; Yangyang NIU ; Donglin KUANG ; Jianzhuang REN ; Xuhua DUAN
Chinese Journal of Hepatobiliary Surgery 2024;30(10):738-743
Objective:To compare the effects of drug-loaded microsphere TACE (D-TACE) and iodinated oil emulsion TACE (cTACE) on liver fibrosis in the treatment of advanced hepatocellular carcinoma (HCC).Methods:Clinical data of 113 patients with HCC treated with D-TACE or cTACE at the First Affiliated Hospital of Zhengzhou University from October 2019 to September 2020 were retrospectively analyzed, including 96 males and 17 females, aged (56.8±9.8) years old. According to treatment protocol, patients were divided into two groups: the D-TACE group ( n=57) and the cTACE group ( n=56). Liver fibrosis panel, fibrosis index (FIB-4), aspartate aminotransferase to platelet ratio index (APRI), and liver stiffness measurement (LSM) were compared between the groups at four timepoints: pre-treatment, one month after the first TACE, one month after the second TACE, and 12 months after the first TACE. Follow-ups were conducted through outpatient visits or telephone reviews to assess patient survivals. Data including the progression-free survival (PFS) and number of TACE sessions were compared between the two groups. Results:The D-TACE group received 2.84±1.12 sessions of treatment during the observation period, compared to 4.05±1.44 sessions of cTACE group ( t=4.94, P<0.001). The median PFS in D-TACE and cTACE groups were 10.0 and 5.0 months, respectively ( P<0.001). At one month after the second TACE and at 12 months after the first TACE, patients in cTACE group had a higher serum levels of fibrosis markers including hyaluronic acid, type IV collagen, type III procollagen N peptide and laminin than those in D-TACE group (all P<0.05). At the same timepoints, patients in cTACE group also had higher APRI, FIB-4 and LSM than those in D-TACE group (all P<0.05). Conclusion:Compared to cTACE, patients in D-TACE group received fewer sessions of treatment during the first year after initial TACE, and the degree of liver fibrosis was also lower in D-TACE group.
7.Safety and efficacy of camrelizumab added to second-line therapy after drug-eluting bead transarterial chemoembolization combined with apatinib for unresectable hepatocellular carcinoma
Yancang ZHANG ; Manzhou WANG ; Xinwei HAN ; Xuhua DUAN ; Jianzhuang REN ; Hao LI ; Wenhui WANG ; Wenze XU
Journal of Clinical Hepatology 2023;39(4):834-842
Objective To investigate the safety and efficacy of camrelizumab added to second-line therapy after drug- eluting bead transarterial chemoembolization (DTACE) combined with apatinib for unresectable hepatocellular carcinoma (HCC). Methods A retrospective analysis was performed for 89 HCC patients with camrelizumab added to second-line therapy who attended The First Affiliated Hospital of Zhengzhou University from December 2019 to December 2020. The primary endpoints were overall survival (OS) and progression-free survival (PFS) after the application of camrelizumab, and the secondary endpoints were objective remission rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs). The Kaplan-Meier method was used to plot survival curves, the Log-rank test was used for stratified analysis of subgroups based on baseline characteristics, and the influencing factors for prognosis were analyzed. Results A total of 89 patients were screened and followed up in this study. The patients were followed up to December 2021, with a median follow-up time of 16 months, a median OS time of 17.0 (95% confidence interval [ CI ]: 15.3-18.7) months, and a median PFS time of 7.0 (95% CI : 6.2-7.8) months. There were significant differences in OS and PFS between the patients with different ECOG-PS scores, liver function Child-Pugh classes, portal vein invasion, patterns of progression, times of DTACE treatment, durations of oral administration of apatinib, and durations of application of camrelizumab (all P < 0.05). At 3 and 6 months after the application of camrelizumab, ORR was 39.3% and 22.4%, respectively, and DCR was 80.9% and 54.1%, respectively. The univariate analysis using the Log-rank test showed that compared with the patients receiving 0 time of DTACE treatment, the patients receiving 3-4 or 1-2 times of DTACE treatment had significant improvements in median OS [22.0 (95% CI : 21.1-22.9) months and 17.0 (95% CI : 15.8-18.2) months vs 10.0 (95% CI : 7.0-13.0) months, χ 2 =31.423, P < 0.001] and PFS [10.0 (95% CI : 7.0-13.0) months and 7.0 (95% CI : 6.2-7.8) months vs 3.0 (95% CI : 1.9-4.1) months, χ 2 =20.741, P < 0.001]; compared with the patients using apatinib for ≤4 months, the patients using apatinib for > 4 months had significant improvements in median OS [21.0 (95% CI : 19.1-22.9) months vs 14.0 (95% CI : 10.4-17.6) months, χ 2 =19.399, P < 0.001] and PFS [9.0 (95% CI : 7.3-10.7) months vs 5.0 (95% CI : 4.0-6.0) months, χ 2 =27.733, P < 0.001]; compared with the patients using camrelizumab for ≤5 months, the patients using camrelizumab for > 5 months had significant improvements in median OS [22.0 (95% CI : 20.2-23.8) months vs 13.0 (95% CI : 9.3-16.7) months, χ 2 =22.336, P < 0.001] and PFS [9.0 (95% CI : 7.0-11.0) months vs 5.0 (95% CI : 4.1-5.9) months, χ 2 =26.141, P < 0.001]. Post-embolization syndrome was the adverse event after DTACE and resolved after symptomatic treatment. Adverse reactions related to targeted drugs and immunotherapy all resolved after symptomatic supportive treatment, with no grade ≥4 adverse reactions, and no patients withdrew from target-free therapy due to TRAEs. Conclusion As for DTACE combined with apatinib in the treatment of unresectable HCC, camrelizumab added after progression has a marked therapeutic efficacy with safe and controllable TRAEs.
8.A cost-effect analysis of transarterial chemoembolization with CalliSpheres beads loaded with arsenic trioxide versus arsenic trioxide iodized oil emulsion in treatment of unresectable liver cancer
Wenhui WANG ; Xuhua DUAN ; Hao LI ; Shuguang JU ; Manzhou WANG ; Jianzhuang REN ; Xinwei HAN
Journal of Clinical Hepatology 2021;37(9):2125-2129
Objective To investigate the cost-effect of transarterial chemoembolization (TACE) with CalliSpheres beads loaded with arsenic trioxide (ATO) (CBATO) versus ATO iodized oil emulsion (conventional TACE, cTACE) in the treatment of unresectable liver cancer. Methods A total of 100 patients with advanced liver cancer who attended The First Affiliated Hospital of Zhengzhou University from May 2017 to December 2018 were enrolled and divided into CBATO group( n =45) and cTACE group( n =55) according to the treatment regimen. Progression-free survival (PFS) was used to evaluate the efficacy of quality-adjusted life year (QALY), and European Quality of Life-5 Dimensions (EQ-5D) index was used to evaluate quality of life. The t -test was used for comparison of continuous data between groups, and the chi-square test was used for comparison of categorical data between groups; the number of surgeries, length of hospital stay, treatment cost, and incremental cost-effectiveness ratio (ICER) were calculated for the two groups, and then a cost-effect analysis was performed. Results Within the PFS time, the per capita hospital cost was 96 446 yuan in the CBATO group and 91 230.43 yuan in the cTACE group. There were significant differences between the two groups in the mean number of surgeries (2.5±0.7 vs 3.4±0.8, t =16.911, P < 0.01) and mean hospital stay (5.8±1.2 days vs 7.5±1.8 days, t =12.459, P < 0.01). The CBATO group had a significantly higher QALY than the cTACE group (0.804 vs 0.512). Compared with the cTACE group, the CBATO group had an ICER of 17 861.53 yuan/QALY for unresectable liver cancer. Conclusion Although CBATO has a higher surgery cost than cTACE, CBATO has a better clinical effect than cTACE and can reduce the number of surgeries and length of hospital stay, with a better postoperative quality of life than cTACE, suggesting that CBATO has marked cost-effect advantages.
9.Observation of short-term efficacy of bronchial arterial chemoembolization combined with anlotinib for treatment of advanced non-small cell lung cancer
Wenhui WANG ; Xuhua DUAN ; Hao LI ; Manzhou WANG ; Fangzheng LI ; Pengfei CHEN ; Wenze XU ; Jianzhuang REN ; Xinwei HAN
Cancer Research and Clinic 2021;33(12):908-912
Objective:To observe the short-term efficacy and safety of bronchial arterial chemoembolization (BACE) combined with anlotinib for treatment of advanced non-small cell lung cancer (NSCLC).Methods:The clinical data of 14 patients with advanced NSCLC in the First Affiliated Hospital of Zhengzhou University from June 2018 to March 2019 were retrospectively analyzed. The short-term efficacy and adverse reactions of BACE combined with anlotinib hydrochloride were evaluated.Results:All patients successfully received BACE treatment twice. The median follow-up time was 19 months (8-26 months). The objective response rate (ORR) of patients at 1, 3 and 6 months after the first treatment was 100.0% (14/14), 71.4% (10/14) and 57.1% (8/14), and the disease control rate (DCR) was 100.0% (14/14), 92.8% (13/14) and 78.6% (11/14), respectively. The median progression-free survival (PFS) time was 9.5 months (95% CI 9.0-17.3 months), and the 6-month and 12-month PFS rates were 78.6% and 28.6%, respectively. The median overall survival (OS) time was 19.0 months (95% CI 18.4-23.1 months), and the 6-month and 12-month OS rates were 100.0% and 85.7%, respectively. Anlotinib hydrochloride-related adverse reactions included hand-foot syndrome [42.9% (6/14)], fatigue [35.7% (5/14)], hypertension [35.7% (5/14)], oral mucositis [28.6% (4/14)], hemoptysis [28.6% (4/14)], elevated aminotransferases [21.4% (3/14)] and diarrhea [14.3% (2/14)]. There were no grade ≥3 adverse reactions. Conclusion:BACE combined with anlotinib is safe and effective for treatment of advanced NSCLC, and the short-term clinical efficacy is satisfactory.
10.Effect of arsenic trioxide-loaded CalliSpheres beads in the treatment of rabbits with VX2 liver tumor
Wenhui WANG ; Xuhua DUAN ; Hao LI ; Fengyao LI ; Shuguang JU ; Manzhou WANG ; Jianzhuang REN ; Xinwei HAN
Journal of Clinical Hepatology 2020;36(12):2730-2734
ObjectiveTo investigate the effect of arsenic trioxide-loaded CalliSpheres beads (CBATO) in transarterial chemoembolization (TACE) in the treatment of rabbits with VX2 liver tumor. MethodsA total of 120 tumor-bearing rabbits were divided into control group, CalliSpheres beads (CB) group (blank beads for TACE), CBATO group, and conventional TACE (cTACE) group (arsenic trioxide lipiodol for TACE) using a random number table, with 30 rabbits in each group. Five rabbits in each group were sacrificed at 12 hours and on days 3, 7, and 14 after TACE, and immunohistochemistry was used to measure the proliferation index and apoptosis percentage of tumor cells in the residual tumor area. The tumor necrotic volume was measure on day 7 after TACE, and the growth rate and necrosis rate of tumor cells were calculated. Ten rabbits were randomly selected from each group for the observation of survival time. An analysis of variance was used for comparison of continuous data between multiple groups, and the least significant difference t-test was used for further comparison between two groups; the Kaplan-Meier survival analysis was used to evaluate survival time, and the log-rank test was used for comparison. ResultsOn day 7 after TACE, the CBATO group had a significantly lower growth rate and a significantly higher necrosis rate of tumor cells than the cTACE group, the CB group, and the control group (all P<0.05). At each time point after TACE, there were significant differences in the proliferation index and apoptosis percentage of tumor cells between the CBATO group and the other three groups (all P<0.05). The median survival time was 26 days in the CBATO group, 18.5 days in the CB group, 22 days in the cTACE group, and 15.5 days in the control group, and the CBATO group had a significantly longer survival time than the other three groups (χ2=3.95, 8.99, and 13.47, P=0.049, P=0.003, and P<0.01). ConclusionCBATO has a better effect than cTACE and CB in the treatment of rabbits with VX2 liver tumor and can significantly improve tumor necrosis rate, promote the apoptosis of tumor cells, and prolong the survival time of experimental animals.

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