Unresectable hepatocellular carcinoma (uHCC)

  • 文章类型: Journal Article
    由于引入了药物洗脱珠(DEB),比较使用碘油的经动脉化疗栓塞(TACE)的结果,也称为常规经动脉化疗栓塞(c-TACE),和DEB-TACE显示相当大的争议。这项研究的目的是比较c-TACE和DEB-TACE治疗不可切除的肝细胞癌(uHCC)的安全性和有效性。
    这项回顾性研究使用倾向评分匹配(PSM)分析,分析了2016年9月至2021年7月在我院治疗的113例原发性肝细胞癌(HCC)的临床数据。1:1匹配后分析两种治疗方式的安全性和有效性。主要终点是无进展生存期(PFS);次要终点包括总生存期(OS),疾病控制率(DCRs),和1、3、6和12个月的客观反应率(ORR),术后并发症。
    29例患者接受DEB-TACE,84例接受c-TACE;28对患者最终配对。匹配后,组间基线特征具有可比性.DEB-TACE组的中位PFS为10个月,而c-TACE组为6个月(P=0.002)。DEB-TACE组的中位OS为23个月。c-TACE组14个月,但差异无统计学意义(P=0.265)。DEB-TACE组1、3、6和12个月时的ORR(69%,78%,60%,和52%)显著高于c-TACE组(39%,39%,26%,8%)(P<0.05)。DEB-TACE组术后3个月DCR明显高于对照组(95%)(P<0.05)。DEB-TACE组有1例术后肝脓肿,引流后患者恢复良好。无严重并发症发生。
    与c-TACE相比,DEB-TACE延长了PFS,并表现出更好的短期ORR,安全性水平相似。然而,在操作系统方面没有显著优势。
    UNASSIGNED: Since the introduction of drug-eluting beads (DEB), the result comparing transarterial chemoembolization (TACE) using lipiodol, also called conventional transarterial chemoembolization (c-TACE), and DEB-TACE shows considerable controversy. The objective of this study was to compare the safety and efficacy of c-TACE and DEB-TACE to treat unresectable hepatocellular carcinoma (uHCC).
    UNASSIGNED: This retrospective study used propensity score matching (PSM) analysis to analyze clinical data from 113 cases of primary hepatocellular carcinoma (HCC) treated at our hospital from September 2016 to July 2021. The safety and efficacy of the two treatment modalities were analyzed after 1:1 matching. The primary endpoint was progression-free survival (PFS); the secondary endpoints included overall survival (OS), disease control rates (DCRs), and objective response rates (ORRs) at 1, 3, 6, and 12 months, and postoperative complications.
    UNASSIGNED: Twenty-nine patients underwent DEB-TACE and 84 received c-TACE; 28 pairs of patients were eventually matched. After matching, baseline characteristics between groups were comparable. The median PFS of the DEB-TACE group was 10 months compared to 6 months in the c-TACE group (P=0.002). The median OS was 23 months in the DEB-TACE group vs. 14 months in the c-TACE group, but the difference was not statistically significant (P=0.265). The ORR at 1, 3, 6, and 12 months in the DEB-TACE group (69%, 78%, 60%, and 52%) were significantly higher than those in the c-TACE group (39%, 39%, 26%, and 8%) (P<0.05). The DCR at postoperative 3 months was significantly higher in the DEB-TACE group (95%) (P<0.05). There was one case of postoperative liver abscess in the DEB-TACE group, and the patient recovered well after drainage. No serious complications occurred.
    UNASSIGNED: Compared to c-TACE, DEB-TACE prolonged PFS and exhibited better short-term ORR with a similar level of safety. However, there was no significant advantage in terms of OS.
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  • 文章类型: Journal Article
    局部治疗联合全身治疗作为不可切除的肝细胞癌(uHCC)的转换治疗的协同作用尚不清楚。这项研究的目的是评估经导管动脉化疗栓塞术(TACE)联合lenvatinib和camrelizumab(TACELENCAM)作为uHCC转换疗法的疗效和安全性。
    这种单臂,多中心,前瞻性研究在中国9家医院进行。患者(年龄18-75岁)诊断为uHCC,东部肿瘤协作组的表现评分(ECOG-PS)为0-1,Child-PughA级接受了卡姆雷珠单抗(200mg,每3周一次)和TACE治疗后的lenvatinib(体重≥60kg:12mg/天;<60kg:8mg/天)。在评估肿瘤符合切除标准后进行手术。不符合手术标准的患者继续接受三联疗法,直到疾病进展或无法耐受的毒性。主要终点是根据改良的实体瘤反应评估标准(mRECIST)和安全性的客观反应率(ORR)。次要终点包括手术转换率,根治性(R0)切除率,疾病控制率(DCR)。本研究在中国临床试验注册中心(ChiCTR2100050410)注册。
    在2021年10月25日至2022年7月20日之间,招募了55名患者。截至2023年6月1日数据截止,中位随访时间为13.3个月(IQR10.6-15.9个月)。三联疗法的最佳肿瘤反应是9例(16.4%)患者的完全反应(CR),部分缓解(PR)33例(60.0%),5例(9.1%)患者病情稳定(SD),或进行性疾病(PD)在7(12.7%)患者。ORR为76.4%(42/55,95%CI,65.2-87.6%),每mRECIST的DCR为85.5%(47/55,95%CI,76.2-94.8%)。55名患者中有24名(43.6%)患有3-4级治疗相关不良事件(TRAE)。没有发生5级TRAE。共有30例(30/55,54.5%)患者被转换为可切除的HCC,29例(29/55,52.7%)患者接受了切除术。R0切除率为96.6%(28/29)。手术人群的主要病理反应(MPR)和病理完全缓解(pCR)率分别为65.5%(19/29)和20.7%(6/29)。分别。只有一名患者出现了Clavien-DindoIIIa并发症(腹部感染)。无Clavien-DindoIIIb-V并发症发生。未达到中位OS和中位PFS。
    三联疗法(TACE+LEN+CAM)有望有效用于uHCC,具有可控的安全性。此外,三联疗法具有良好的转换效率,转换治疗后的手术是可行和安全的。为了阐明在三联疗法后接受手术治疗的uHCC患者是否比仅接受三联疗法的患者获得更好的生存益处,需要精心设计的随机对照试验.
    本研究由福建省自然科学基金资助,中国(2022J01691)和福建省卫生科技青年基金项目,中国(2022QNA035)。
    UNASSIGNED: The synergistic effect of locoregional therapy in combination with systemic therapy as a conversion therapy for unresectable hepatocellular carcinoma (uHCC) is unclear. The purpose of this study was to evaluate the efficacy and safety of transcatheter arterial chemoembolisation (TACE) combined with lenvatinib and camrelizumab (TACE + LEN + CAM) as conversion therapy for uHCC.
    UNASSIGNED: This single-arm, multicentre, prospective study was conducted at nine hospitals in China. Patients (aged 18-75 years) diagnosed with uHCC, an Eastern Cooperative Oncology Group performance score (ECOG-PS) of 0-1 and Child-Pugh class A received camrelizumab (200 mg, every 3 weeks) and lenvatinib (bodyweight ≥60 kg: 12 mg/day; <60 kg: 8 mg/day) after TACE treatment. Surgery was performed after tumour was assessed as meeting the criteria for resection. Patients who did not meet the criteria for surgery continued to receive triple therapy until disease progression or intolerable toxicity. Primary endpoints were objective response rate (ORR) according to the modified Response Evaluation Criteria in Solid Tumours (mRECIST) and safety. Secondary endpoints included the surgical conversion rate, radical (R0) resection rate, and disease control rate (DCR). This study was registered with Chinese Clinical Trial Registry (ChiCTR2100050410).
    UNASSIGNED: Between Oct 25, 2021, and July 20, 2022, 55 patients were enrolled. As of the data cutoff on June 1, 2023, the median follow-up was 13.3 months (IQR 10.6-15.9 months). The best tumour response to triple therapy was complete response (CR) in 9 (16.4%) patients, partial response (PR) in 33 (60.0%) patients, stable disease (SD) in 5 (9.1%) patients, or progressive disease (PD) in 7 (12.7%) patients. The ORR was 76.4% (42/55, 95% CI, 65.2-87.6%), and the DCR was 85.5% (47/55, 95% CI, 76.2-94.8%) per mRECIST. Twenty-four (43.6%) of the 55 patients suffered from grade 3-4 treatment-related adverse events (TRAEs). No grade 5 TRAEs occurred. A total of 30 (30/55, 54.5%) patients were converted to resectable HCC and 29 (29/55, 52.7%) patients underwent resection. The R0 resection rate was 96.6% (28/29). The major pathologic response (MPR) and pathologic complete response (pCR) rates in the surgery population were 65.5% (19/29) and 20.7% (6/29), respectively. Only one patient developed a Clavien-Dindo IIIa complication (abdominal infection). No Clavien-Dindo IIIb-V complications occurred. The median OS and median PFS were not reached.
    UNASSIGNED: The triple therapy (TACE + LEN + CAM) is promising active for uHCC with a manageable safety. Moreover, triple therapy has good conversion efficiency and the surgery after conversion therapy is feasible and safe. To elucidate whether patients with uHCC accepting surgical treatment after the triple therapy can achieve better survival benefits than those who receive triple therapy only, well-designed randomised controlled trials are needed.
    UNASSIGNED: This study was funded by the Natural Science Foundation of Fujian Province, China (2022J01691) and the Youth Foundation of Fujian Province Health Science and Technology Project, China (2022QNA035).
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  • 文章类型: Journal Article
    将肿瘤抗原暴露于免疫系统是确保免疫疗法疗效的关键。SBRT是揭示肿瘤特异性抗原的主要途径,可以增强免疫应答。我们旨在探讨托里帕利马联合安洛替尼治疗SBRT术后uHCC的临床疗效和安全性。
    这是一个前景,单臂,探索性临床研究。ECOGPS评分为0-1,Child-PughA级或B级的uHCC患者,纳入B期或C期BCLC,接受SBRT(8Gy*3)治疗,随后接受托里帕利马和安洛替尼6个周期的联合治疗.主要终点是无进展生存期(PFS),次要终点是客观缓解率(ORR)。疾病控制率(DCR),总生存期(OS),和治疗相关不良事件(TRAEs)的发生率。连续变量以中位数和范围表示。用Kaplan-Meier方法研究存活。分类数据以n(百分比)表示。
    在2020年6月至2022年10月之间,共招募了20例中晚期uHCC患者。所有病例均有多发肝内转移,或者大血管侵犯,或者两者兼而有之,其中5例伴淋巴结或远处转移。截至2022年9月,中位随访时间为7.2个月(范围,1.1-27.7个月)。目前无法评估中位生存时间,根据iRecist,中位PFS为7.4个月(范围,1.1-27.7个月),ORR15.0%,和DCR50.0%。14例患者出现治疗相关不良事件,发生率为70%。18个月和24个月的总生存率分别为61.1%和50.9%,分别。无进展生存率分别为39.3%和19.7%。
    通过SBRT暴露HCC的特异性抗原可能会提高托里帕利马和安洛替尼联合治疗uHCC的疗效,不良反应可控,值得进一步探索。
    www.clinicaltrials.gov,标识符ChiCTR2000032533。
    UNASSIGNED: Exposing tumor antigens to the immune system is the key to ensuring the efficacy of immunotherapy. SBRT is the main way to reveal the specifical antigens of tumors which can enhance the immune response. We aimed to explore the clinical efficacy and safety of Toripalimab combined with Anlotinib for uHCC after SBRT.
    UNASSIGNED: This is a prospective, single-arm, explorative clinical study. uHCC patients with an ECOG PS score of 0-1, Child-Pugh class A or B, and BCLC stage B or C were included and treated with SBRT(8Gy*3) followed by 6-cycle combinational therapy with Toripalimab and Anlotinib. The primary endpoint was progression-free survival (PFS) and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and incidence of treatment-related adverse events (TRAEs). Continuous variables were presented as medians and ranges. Survivals were studied with the Kaplan-Meier method. Categorical data were expressed as n (percentage).
    UNASSIGNED: Between June 2020 and October 2022, a total of 20 patients with intermediate-advanced uHCC were enrolled. All cases had multiple intrahepatic metastases, or macrovascular invasion, or both, among whom 5 cases with lymph node or distant metastases. Until September 2022, the median follow-up time was 7.2 months (range, 1.1-27.7 months). Median survival time could not be assessed at the moment, based on iRecist, median PFS was 7.4 months (range, 1.1-27.7 months), ORR 15.0%, and DCR 50.0%. 14 patients experienced treatment-related adverse events with an incidence of 70%. The overall survival rates at 18 months and 24 months were 61.1% and 50.9%, respectively. And the progression-free survival rates were 39.3% and 19.7%.
    UNASSIGNED: Exposure of specific antigens of HCC via SBRT may improve the efficacy of combinational therapy with Toripalimab and Anlotinib for uHCC with manageable adverse effects, which deserves further exploration.
    UNASSIGNED: www.clinicaltrials.gov, identifier ChiCTR2000032533.
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  • 文章类型: Journal Article
    OBJECTIVE: To compare the efficacy and safety of combined treatment with lenvatinib and transarterial chemoembolization (TACE) versus TACE only in patients with unresectable hepatocellular carcinoma (uHCC).
    METHODS: Of the 120 patients enrolled in this study, 60 patients received treatment with TACE only, and 60 patients received TACE plus lenvatinib. We retrospectively compared the clinical outcomes including overall survival (OS), progression-free survival (PFS), and tumor response between the two groups. Both PFS and tumor response were based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Adverse events were analyzed to assess the safety profiles.
    RESULTS: The 1-year and 2-year OS rates were significantly higher in the TACE + lenvatinib group (88.4% and 79.8%) than that in the TACE group (79.2% and 49.2%, p = 0.047). A similar PFS benefit was observed in the TACE + lenvatinib group (1-y PFS rate: 78.4% vs. 64.7%, 2-y PFS rate: 45.5% vs. 38.0%, p < 0.001). The best overall objective response rate (ORR) was also better with TACE + lenvatinib treatment (ORR: 68.3% vs. 31.7%, p < 0.001) and disease control rate (DCR) numerically increased in the TACE + lenvatinib treatment (93.3% vs. 86.7%, p = 0.224). Patients\' liver function remained comparable to baseline in the TACE + lenvatinib group. The most common adverse events were decreased albumin (55.0%), hypertension (48.3%) and decreased platelet count (46.7%) in the TACE + lenvatinib group.
    CONCLUSIONS: Combination treatment with TACE and lenvatinib may significantly improve clinical outcomes over TACE monotherapy with a manageable safety profile for unresectable HCC. The efficacy of the combination treatment should be validated in prospective studies with a large sample size.
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