Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2616663 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Interventions: Radiofrequency ablation will be done after hepatic arterial embolization with degradable starchmicrosphere and mitomycinC. Twenty-five patients with colorectal cancer livr metastasis will be treated and followed for 2 years. Study period will be 36 months.
Primary outcome(s): Local tumo control
Study Design: Single arm Non-randomized
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2022-11-01 | GSE186103 | GEO
Project description:This study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with hepatic metastases through arterial chemoembolization.
| 90705 | ecrin-mdr-crc
Project description:One restriction to the development and application of transcatheter arterial chemoembolization (TACE) therapy is the lack of an inherently radiopaque embolic whose location and distribution can be precisely visualized in real time and be used for non-invasive examination after surgery. Methods: A one-step electrospray method was developed to fabricate calcium alginate microspheres loaded with tantalum nanoparticles (Ta@CaAlg). The parameters of electrospraying were assessed. The in vivo X-ray imaging capability and embolic effect of Ta@CaAlg microspheres were evaluated in the renal arteries of normal rabbits by digital radiography and computed tomography. Doxorubicin hydrochloride (Dox) was chosen as a model drug, and the drug loading capacity and release behavior of these microspheres was valuated in vitro.Results: Spherical Ta@CaAlg microspheres with monodisperse sizes ranging from 150 to 1200 ?m were fabricated by electrospraying. The results of an in vivo study showed that Ta@CaAlg microspheres possessed the qualities of both embolic agents and contrast media. They could not only feed back the real-time location and distribution of the embolic microspheres but also maintained clear X-ray imaging of embolized sites for up to 4 weeks as assessed by digital radiography and computed tomography. Digital subtraction angiography showed that they had an excellent embolic effect. Ta@CaAlg microspheres could be loaded with Dox to form "3-in-1" embolic microspheres. The maximum Dox loading was 97.3 mg Dox per mL beads and loaded microspheres exhibited pH-dependent release profiles. Conclusion: The X-ray opacity and drug-loading capability of Ta@CaAlg microspheres offers great promise in direct, real-time, in vivo investigation for TACE and long-term non-invasive re-examination.
| S-EPMC6160769 | biostudies-literature
Project description:PurposeTransarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres.Materials and methodsAt a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual.ResultsBetween December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, -0.1%; 95% CI, -9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively.ConclusionThere was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC.
| S-EPMC4966514 | biostudies-literature
Project description:In this work, we applied single-cell transcriptome sequencing on primary human liver tissue samples to study cellular processes underlying human liver regeneration. In order to study regeneration-specific cellular processes we obtained primary healthy liver tissue samples and liver tissue samples from patients that underwent a preoperative medical procedure called portal vein embolization (PVE). This medical treatment is performed to enlarge part of the liver such that a diseased portion can be removed avoiding liver insufficiency and thus we used post-PVE-derived tissues as a model to study liver regeneration in humans. This paradigm enabled us to catalog cell states related to tissue structure in two important and physiologically relevant conditions: hypertrophy and atrophy. In addition, we overcame technical challenges and provided novel protocols and pipelines for generating high quality liver cell atlases from frozen specimens showing consistency in results between fresh and frozen tissue datasets. Moreover, we established tissue-scale iterative indirect immunofluorescence imaging to enable high-dimensional spatial analysis of perivascular microenvironments and uncover cellular and histological alterations to regenerating liver lobules.
2024-04-13 | E-MTAB-12594 | biostudies-arrayexpress
Project description:Poly(L-lactic acid) microspheres loaded with holmium-166 acetylacetonate (166Ho-PLLA-MS) are a novel microdevice for intra-arterial radio-embolization in patients with unresectable liver malignancies. The neutron activation in a nuclear reactor, in particular the gamma heating, damages the 166Ho-PLLA-MS. The degree of damage is dependent on the irradiation characteristics and irradiation time in a particular reactor facility. The aim of this study was to standardize and objectively validate the activation procedure in a particular reactor. The methods included light- and scanning electron microscopy (SEM), particle size analysis, differential scanning calorimetry, viscometry, thermal neutron flux measurements and energy deposition calculations. Seven hours-neutron irradiation results in sufficient specific activity of the 166Ho-PLLA-MS while structural integrity is preserved. Neutron flux measurements and energy deposition calculations are required in the screening of other nuclear reactors. For the evaluation of microsphere quality, light microscopy, SEM and particle size analysis are appropriate techniques.
| S-EPMC2708336 | biostudies-other
Project description:A cell atlas of the regenerating human liver after portal vein embolization
| PRJEB59716 | ENA
Project description:BackgroundTransarterial (chemo-)embolization/lipiodolization (TAE/TAL) might be an attractive minimally invasive alternative to surgery in the treatment of symptomatic hepatic haemangioma. This review assesses the efficacy and safety of TAE/TAL as primary treatment for symptomatic hepatic haemangioma.MethodsA systematic search of the literature was performed by two reviewers following the PRISMA guidelines. Cohort studies and case reports were identified; outcomes of cohort studies were reported. The primary efficacy outcome was tumour size before and after TAE/TAL. Improvement of symptoms and quality of life (QoL) were secondary outcomes; the primary safety outcome was complications. The Downs and Black statement was used for quality assessment.ResultsEighteen cohort studies were identified, including 1284 patients. TAE/TAL led to a decrease in tumour size in 1100/1223 (89.9%) patients and to improvement or disappearance of symptoms in 1080/1096 (98.5%) patients. A significant decrease in tumour size from 9.79 ± 0.79 cm to 4.00 ± 1.36 cm (p < 0.001) was shown. Grade 3 complications occurred in 37/1284 (2.9%) patients. Surgical treatment was necessary in 35/1284 (2.7%) of patients.ConclusionTAE/TAL appears to be a promising and safe treatment to decrease tumour size of hepatic haemangioma. The technique might also provide partial relief of symptoms, although no randomized clinical trials or prospective studies using validated QoL questionnaires are available. TAE/TAL may be considered as a viable alternative to resection.
| S-EPMC6503075 | biostudies-literature
Project description:The aim of this study is to evaluate the toxicity of holmium-166 poly(L-lactic acid) microspheres administered into the hepatic artery in pigs.Healthy pigs (20-30 kg) were injected into the hepatic artery with holmium-165-loaded microspheres ((165)HoMS; n=5) or with holmium-166-loaded microspheres ((166)HoMS; n=13). The microspheres' biodistribution was assessed by single-photon emission computed tomography and/or MRI. The animals were monitored clinically, biochemically, and ((166)HoMS group only) hematologically over a period of 1 month ((165)HoMS group) or over 1 or 2 months ((166)HoMS group). Finally, a pathological examination was undertaken.After microsphere administration, some animals exhibited a slightly diminished level of consciousness and a dip in appetite, both of which were transient. Four lethal adverse events occurred in the (166)HoMS group due either to incorrect administration or comorbidity: inadvertent delivery of microspheres into the gastric wall (n=2), preexisting gastric ulceration (n=1), and endocarditis (n=1). AST levels were transitorily elevated post-(166)HoMS administration. In the other blood parameters, no abnormalities were observed. Nuclear scans were acquired from all animals from the (166)HoMS group, and MRI scans were performed if available. In pigs from the (166)HoMS group, atrophy of one or more liver lobes was frequently observed. The actual radioactivity distribution was assessed through ex vivo (166m)Ho measurements.It can be concluded that the toxicity profile of HoMS is low. In pigs, hepatic arterial embolization with (166)HoMS in amounts corresponding with liver-absorbed doses of over 100 Gy, if correctly administered, is not associated with clinically relevant side effects. This result offers a good perspective for upcoming patient trials.
| S-EPMC2440967 | biostudies-other