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Callispheres

Manufactured by Jiangsu Hengrui Medicine
Sourced in China

CalliSpheres is a laboratory equipment product. It is designed for the cultivation and encapsulation of cells.

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7 protocols using callispheres

1

Drug-Eluting Bead TACE for Metastatic Cancers

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TACE was carried out using a micro-puncture system via placing a 5F vascular introducer (Boston Scientific, USA) through a transfemoral arterial access route. Angiography of the hepatic artery was executed to provide the liver’s vascular anatomy. The CalliSpheres® (Jiangsu Hengrui Medicine Co, Ltd., China) DEB loading was performed as follows: after the injection of CBs to the chemotherapy reagent solution was performed, the mixed solution was shaken up every 5 minutes for 30 minutes in an injector at a temperature of 23–28 °C. After that, adding non-ionic contrast agent into the same injector was performed at the ratio of (1–1.2):1 compared to the mixed solution and placed for 5 minutes at a temperature of 23–28 °C for use. Two mL 100–300 µm CalliSpheres® DEBs (Jiangsu Hengrui Medicine Co, Ltd., China) loaded with 50–80 mg of anthracyclines (doxorubicin) for metastatic lung cancer and breast cancer patients, and 100–200 mg irinotecan for intestinal cancer, gastric cancer, and pancreatic cancer patients, were used and administered until stasis in each patient. After the procedure, patients were admitted and monitored to the hospital overnight.
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2

Combination Therapy for Liver Cancer

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The initial TACE treatment should be performed within 30 days before or after systemic treatment. Since no significant difference in efficacy between conventional TACE and drug-eluting beads-TACE (DEB-TACE) has been reported,16 (link),17 (link) specific method was chosen by experienced interventional radiologists based on tumor burden, macrovascular invasion, liver function, and patient tolerance from either (1) DEB-TACE: Epirubicin was loaded into 100–300 μm or 300–500 μm HepaSphere (Merit Medical, USA) or CalliSpheres (Jiangsu Hengrui Medicine Co., Ltd., Jiangsu, China) microspheres; or (2) Conventional TACE: Ethiodized oil (Jiangsu Hengrui Medicine Co., Ltd., Jiangsu, China) and epirubicin were thoroughly mixed into a lipiodol emulsion in a ratio of 2:1. Gelatin sponge particle was used for embolization in either case. The tumor feeding artery was catheterized super-selectively, and the chemoembolization agents were injected until the tumor feeding artery was completely embolized. Lenvatinib was suspended 1–3 days before and after TACE, and then resumed to original level once liver function has recovered. Atezolizumab/Bevacizumab was administered according to the treatment schedule without being affected by TACE.
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3

Transarterial Chemoembolization with Drug-Eluting Beads

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All procedures were conducted using the GE3100 DSA system. Before the procedure, doxorubicin in the range of 60–80mg was loaded onto drug-eluting beads (CalliSpheres, Jiangsu Hengrui Medicine Co. Ltd., China). The size of the beads, ranging from 100–300 or 300–500µm, was selected based on the tumor diameter and blood supply characteristics. Initially, diagnostic angiographies were performed using a 4F RH catheter to gather all pertinent tumor information, including location, diameter, and feeding arteries. Subsequently, a microcatheter was advanced in a superselective manner into the feeding artery. The drug-eluting beads were then slowly injected into the vessel under fluoroscopy. Upon reaching the intended endpoint, a follow-up angiography was performed to assess the effectiveness of embolization.
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4

HMGB1 expression and TACE outcomes

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Due to the differences in drug release rate and local concentration between the two TACE modalities, we initially divided patients into DEB-TACE (CalliSpheres®, Jiangsu Hengrui Medicine Co. Ltd., Jiangsu, P.R. China) group and c-TACE groups. Then, we classified that patients with pre-HMGB1 level in serum above 17.5 pg/ml as the preoperative high expression group and others as the preoperative low expression group. Whether the change of HMGB1 concentration in the sample on the first day after TACE is more than 50% is defined as the grouping standard. According to the high change group of HMGB1 before TACE increased by more than 50%, and the patients with variation less than 50% were low change group.
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5

Raltitrexed-Loaded Microspheres Embolization

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The femoral artery was accessed after local anesthesia and a 5F-Cobra catheter (Terumo, Japan) was introduced. Tumor-feeding vessels were catheterized and a 2.7-F microcatheter (Progreat, Terumo, Japan) was used for super-selection. The dose of raltitrexed is calculated based on the Body Mass Index, and is generally 4 mg. Raltitrexed (4 mg) was pre-loaded into microspheres (CalliSpheres, Jiangsu Hengrui Medicine Co. Ltd., Jiangsu, China) for 30 min, and then mixed with iodixanol (ratio 1:1). A bottle of 100–300 μm or 300–500 μm raltitrexed-loaded microspheres was slowly injected into the tumor-feeding vessels. Polyvinyl alcohol particles (Merit, American) or gelatin sponge particles were used if one bottle of microspheres embolization was insufficient (Figs. 1CD, 2CE, 3BCE and 4BCE).
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6

Doxorubicin-Loaded CalliSpheres® Beads for Chemoembolization

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CalliSpheres® (Jiangsu Hengrui Medicine Co. Ltd, Jiangsu, China) beads (100-300 μm) were loaded with doxorubicin (50 - 80 mg). The loading process (21 (link)) was: 1) the concentration of doxorubicin was 20 mg/ml; 2) the supernatant of CalliSpheres® beads was excluded, then beads and doxorubicin were mixed; 3) non-ionic contrast agent was added into the mixture (using a 1:1 ratio) for further application.
Before performing chemoembolization, celiac arteriography and superior mesenteric arteriography were implemented to evaluate the feeding arteries of the tumor. Then, microcatheters were used to catheterize the tumor-feeding arteries. The mixture of CalliSpheres® beads and non-ionic contrast agent were injected at the speed of 1 ml/min. The injection was completed if the stasis flow of the contrast agent was observed. If one vial of CalliSpheres® beads did not complete the chemoembolization, regular Embosphere (Biosphere Medical, Roissy en France, France) with 100-300 μm was used.
DEB-TACE was repeated “on demand” in patients with no deteriorating physical status or organ function after contrast-enhanced MRI or CT detected viable tumors during follow-up.
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7

Chemoembolization of Epirubicin and Gemcitabine

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Callispheres (Jiangsu Hengrui Medicine Co. Ltd., Jiangsu, China) beads (100–300 μm or 300–500 μm) were applied as the carrier to load epirubicin or gemcitabine. Epirubicin's loading dose ranged from 60 to 80 mg, whereas the dose of gemcitabine was 400 mg. The loading process was as follows: chemoembolization reagents were dissolved at a concentration of 20 mg/mL; 1 vial of Callispheres beads was stirred and the supernatant was extracted. Subsequently, the beads and the chemoembolization solution were mixed by a tee joint; the mixed solution was shaken and allowed to stand for 30 minutes at room temperature. Subsequently, the non-ionic contrast agent was added and the mixed solution was allowed to stand for an additional 5 minutes for further application.
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