Hepatic artery infusion chemotherapy with systemic capecitabine and camrelizumab for treating unresectable hilar cholangiocarcinoma: An initial investigation of efficacy and safety.

OBJECTIVE: This study aimed to evaluate the efficacy and safety of sequential treatment of continuous transcatheter hepatic artery infusion chemotherapy (HAIC) with systemic capecitabine monotherapy and camrelizumab for treating unresectable hilar cholangiocarcinoma (HCCA). METHODS: This study retrospectively analyzed patients with unresectable HCCA admitted to Linyi Cancer Hospital in Shandong Province from October 2019 to December 2021. All enrolled patients were treated with HAIC (mFOLFOX7) + camrelizumab for 2-6 cycles and administered systemic therapy with capecitabine and camrelizumab. The objective response rate (ORR), disease control rate (DCR), and adverse reactions of patients were assessed. The Kaplan-Meier method was used to describe overall survival (OS), and univariate and multivariate Cox regression models were utilized to analyze the influencing factors of OS. RESULTS: This study included 34 patients, ORR was 61.76% (21/34), and DCR was 97.06% (33/34) after two HAIC cycles. The median follow-up time was 17.5 months, with an average of 18.32 ± 8.06 months, and the median OS was 20.0 months. HAIC-related adverse reactions included mainly gastrointestinal symptoms and hematological toxicity caused by chemotherapy drugs, all of which were grades 1-2. Further, adverse events for camrelizumab treatment included fatigue, skin rash, and hypothyroidism, all of which were grade <3. Cox regression analysis revealed that the periductal infiltrating type of growth pattern indicated a worse OS, whereas more HAIC cycles (5 ~ 6) were a protective factor for OS. CONCLUSION: HAIC sequentially combined with systemic capecitabine chemotherapy and a programmed death-1 inhibitor displayed favorable effects for unresectable HCCA, with controllable adverse reactions.

The second-line treatment of hepatocellular carcinoma with CalliSpheres drug-eluting bead transarterial chemoembolization combined with regorafenib: A safety and efficacy analysis.

BACKGROUND: This study aimed to investigate the efficacy and safety of CalliSpheres drug-eluting beads transarterial chemoembolization (DEB-TACE) combined with regorafenib in the second-line treatment of unresectable hepatocellular carcinoma. METHODS: A retrospective analysis was made of 34 patients with unresectable hepatocellular carcinoma (HCC) that had progressed after first-line treatment in Linyi Tumor Hospital from October 2019 to June 2021. These patients were divided into observation group (n = 15) and control group (n = 19) based on their treatment plans, who were respectively treated with regorafenib alone and regorafenib combined with DEB-TACE. The objective response rate (ORR) and the disease control rate (DCR) were evaluated by the modified Response Evaluation Criteria in Solid Tumors (mRECIST), and the progression-free survival (PFS) and the overall survival (OS) were calculated; the factors influencing PFS and OS of patients were analyzed by the Cox proportional hazards model; and the adverse reactions to the treatments were observed and recorded. RESULTS: After 2 months of treatment, the ORR and the DCR of the observation group were 73.3% (11/15) and 86.7% (13/15) respectively, both higher than 10.5% (2/19) and 47.4% (9/19) of the control group. Their differences are statistically significant (P < 0.05). There were no statistically significant differences in the incidences of regorafenib-related adverse reactions including hand-foot skin reactions, fatigue, hypertension, diarrhea, and proteinuria between the two groups (P > 0.05). In the observation group, the main adverse reactions to DEB-TACE such as fever, pain, nausea, and vomiting were relieved after symptomatic treatment, and no serious complications such as ectopic embolization of CalliSpheres drug-eluting beads occurred. As of July 31, 2022, the median follow-up time was 12.5 months, and the average was (14.00 ± 5.69) months. The median PFS was 9 months in the observation group, and 6 months in the control group, presenting a statistically significant difference (P < 0.05), and the median OS was 18 months in the observation group, and 12 months in the control group, also presenting a statistically significant difference (P < 0.05). The results of monofactor prognostic analysis showed that Child grade, AFP level, and treatment method had an influence on the PFS and the OS of liver cancer patients receiving regorafenib second-line treatment (P < 0.05), and the results of multifactor prognostic analysis showed that child grade and treatment method independently influenced the PFS of patients, while treatment method independently influenced the OS of patients (P < 0.05). CONCLUSIONS: DEB-TACE combined with regorafenib is safe and feasible in the treatment of unresectable HCC, with good efficacy and mild adverse reactions.

Safety and efficacy of transarterial chemoembolization combined with tyrosine kinase inhibitors and camrelizumab in the treatment of patients with advanced unresectable hepatocellular carcinoma.

Objective: This study was aimed to evaluate the efficacy and safety of transarterial chemoembolization combined with tyrosine kinase inhibitors and camrelizumab in the treatment of unresectable hepatocellular carcinoma and to explore a new therapeutic strategy for the treatment of advanced HCC. Patients and methods: A total of 87 patients aged 18-75 years with at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (version 1.1) were included in the study. TACE was administered as needed, and camrelizumab and TKI medication were initiated within two weeks and one week after TACE, respectively. The primary endpoints were progression-free survival and objective response rate. Results: The 87 patients in this trial were last evaluated on September 28, 2022, and 35.8% were still receiving treatment at the data cutoff. A total of 34 patients (39.1%) died, and the median OS was not reached. The median PFS was 10.5 months (95% CI: 7.8-13.1). The ORR rate was 71.3% (62/87), and the DCR rate was 89.7% (78/87) per mRECIST. According to RECIST version 1.1, the ORR rate was 35.6% (31/87), and the DCR rate was 87.4% (76/87). Ten patients (11.5%) successfully underwent conversion therapy and all achieved R0 resection. Two patients achieved a complete pathological response, four achieved a major pathological response, and four had a partial response. All treatment-related adverse events were tolerated. No serious adverse events were observed, and no treatment-related deaths occurred. Conclusions: TACE combined with TKI and camrelizumab was safe and effective in treating advanced HCC. Triple therapy may benefit patients with large tumor burden and portal vein cancer thrombus and is expected to provide a new treatment strategy for advanced HCC. Clinical Trial Registration: ClinicalTrials.gov, identifier ChiCTR2000039508.

CalliSpheres® microsphere transarterial chemoembolization combined with 125I brachytherapy for patients with non-small-cell lung cancer liver metastases.

Objective: Poor prognosis and limited treatments of liver metastases from non-small-cell lung cancer (NSCLC) after radical surgery are critical issues. The current study aimed to evaluate the efficacy and safety of CalliSpheres® microsphere transarterial chemoembolization (CSM-TACE) plus 125I brachytherapy in these patients. Methods: A total of 23 patients with liver metastases from NSCLC after radical surgery were included. All patients received CSM-TACE 1-3 times, then 125I brachytherapy was carried out following the last CSM-TACE. Complete response (CR), objective response rate (ORR), disease control rate (DCR), survival, and adverse events were evaluated. Results: CR, ORR and DCR were 43.5%, 87.0%, and 100%, respectively, at three months; furthermore, they were 78.3%, 100%, and 100% accordingly at six months. Moreover, most European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) subscales of functions (including physical and emotional function) and symptoms (including pain, nausea, and vomiting) were generally improved at three months (all P < 0.05). Furthermore, median progression-free survival (PFS) was 14.0 [95% confidence interval (CI): 10.4-17.6] months, with a 1-year PFS rate of 62.9%, but the 2-year PFS rate was not reached. Moreover, the median overall survival (OS) was 22.0 (95% CI: 16.8-27.2) months, with a 1-year OS rate of 91.3% and a 2-year OS rate of 43.5%. Additionally, the main adverse events included fever (100%), pain (65.2%), liver function impairment (65.2%), fatigue (56.5%), and nausea and vomiting (52.2%), which were all categorized as grade 1-2. Conclusion: CSM-TACE plus 125I brachytherapy is effective and safe in patients with liver metastases from NSCLC after radical surgery, providing a potentially optimal option in these patients.

CalliSpheres® microspheres drug-eluting bead transhepatic artery chemoembolization with or without sorafenib for the treatment of large liver cancer: a multi-center retrospective study.

PURPOSE: To explore the clinical efficacy and safety of CalliSpheres® microspheres drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with sorafenib in the treatment of large liver cancer. METHOD: The study retrospectively analyzed 90 patients with large liver cancer. 42 patients who received DEB-TACE and sorafenib were included in the experimental group and 48 patients who received only DEB-TACE were included in the control group. The efficacy, TTP, OS and ARs were evaluated and further analysis was conducted on factors which might affect the prognosis. RESULTS: As of June 2020. The median OS of the experimental group was significantly longer than that of the control group (18.6 months vs. 12.7 months), and the TTP was also longer in the experimental group (8.3 months vs. 6.9 months). Three months after the intervention, the ORR and DCR of the experimental group were significantly higher than those of the control group. The main ARs of the experimental group taking sorafenib included hand-foot syndrome, skin rash, diarrhea, fatigue, hypertension, and anorexia. And they could be alleviated through treatment of the symptoms. TACE-related ARs for both groups were fever, pain, nausea, and vomiting, and there was no significant difference. Logistic regression analysis showed that the combined sorafenib treatment was a protective factor improving the prognosis of patients with large liver cancer, and risk factors were the number of tumors and vascular invasion. CONCLUSION: DEB-TACE combined with sorafenib is safe and well tolerated in the treatment of large liver cancer. It can improve the tumor control rate and prolong the survival time.

Transcatheter arterial chemoembolization combined with low-dose apatinib in the treatment of unresectable hepatocellular carcinoma in elderly patients: Efficacy and safety.

CONTEXT: Owing to the increasing age of the population, the incidence of hepatocellular carcinoma (HCC) in the elderly is increasing annually. AIMS: This study aims to investigate the clinical efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with low-dose apatinib for unresectable HCC treatment in elderly patients (≥65 years). SETTINGS AND DESIGN: The clinical data from 61 elderly patients with unresectable HCC who were retrospectively analyzed. SUBJECTS AND METHODS: Of these 61 patients, 27 received TACE combined with low-dose (250 mg/qd) apatinib (experimental group), and 34 patients received the standard TACE treatment (control group). The short-term efficacy was evaluated according to the mRECIST1.1 standards, and the mid- and long-term efficacy and safety in the two groups of patients were evaluated. STATISTICAL ANALYSIS USED: Statistical analyses were performed using the Statistical Package for the Social Sciences software (version 20.0; SPSS). RESULTS: Both the objective response rate and disease control rate of the experimental group were significantly higher than those of control group (P < 0.05). The 6-month and 12-month survival rates of the experimental group were significantly higher than those of control group too (P < 0.05). The median survival in the experimental group was longer than in the control group (26.0 months vs. 20.0 months). The adverse reactions related to the intake of apatinib were higher in the experimental than the control group, but were generally alleviated after symptomatic treatment. CONCLUSIONS: TACE combined with low-dose apatinib provides an alternative treatment option for elderly patients with unresectable HCC. Our clinical study has proven its safety and efficacy.

High expression of Parkin predicts easier recurrence of patients with adjuvant transarterial chemoembolization.

AIM: To investigate the clinical significance of E3 ubiquitin ligase Parkin in patients with adjuvant transarterial chemoembolization after curative resection of hepatocellular carcinoma. METHODS: Parkin expression of hepatocellular carcinomas was detected and its correlation with clinicopathological factors was analyzed with χ2 test. The significance of Parkin in prognosis and recurrence was analyzed with log-rank test and the Cox-regression model. RESULTS: High expression of Parkin could result in lower recurrence-free survival rate instead of overall survival rate. Larger tumor size, positive tumor recurrence, advanced T, N, M and TNM stage were significantly associated with poorer prognosis. Larger tumor size, advanced T and TNM stage could lead to higher recurrence. CONCLUSION: High Parkin expression could predict easier recurrence to patients with adjuvant transarterial chemoembolization.