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Background: PEP503 (aka NBTXR3) is a novel radio-enhancer composed of functionalized hafnium oxide nanoparticles that increases the energy deposition of radiotherapy. A phase 3 study in soft ...tissue sarcoma patients has significantly increased pCR and R0 when PEP503 was added to preop radiotherapy. This phase 1b/2 study was conducted with the aim to identify a recommended phase 2 dose (RP2D), and evaluate the efficacy of PEP503 intratumoral injection in combination with concurrent chemoradiation (CCRT) in patients with locally advanced rectal cancer (LARC). Methods: Patients with stage T3-T4 LARC (or with unresectable disease) suitable for neoadjuvant CCRT were enrolled. An intratumoral single administration of PEP503 (multiple punctures) was done 24 to 72 hours prior to IMRT of 50 Gy in 25 fractions of 2 Gy per fraction over 5-6 weeks with concurrent capecitabine or 5-FU. Traditional 3 + 3 design with 4 levels, 5%, 10%, 15%, and 22%, of the baseline GTV as measured by MRI, of PEP503 were assessed in Phase Ib. PEP503 nanoparticles intratumoral dispersion was analyzed by CT-scan. Surgery was performed 8 to 12 weeks after the completion of CCRT for patients with resectable tumors. Body kinetics was evaluated in Phase Ib. (ClinicalTrials.gov, NCT02465593) Results: Thirty-two (32) patients (male/female: 20/12; median age 62 years, range 38 to 76) were enrolled (1 dropped out before starting CCRT). In Phase 1b, 20 patients were treated and dose was escalated to 22%. RP2D was then determined as 22% with 6 patients treated at this dose level without DLT. Twelve (12) patients were included in the Phase 2. One (1) (3.2%) and 19 (61.3%) of evaluable patients (n = 31) had CR and PR, respectively, as the best tumor response across dose levels. No patient progressed as all evaluable patients (n = 31) achieved disease control for a DCR of 100%. Furthermore, twenty-five patients underwent surgery, of which 24 (96%) had microscopically clear resection margins and 5 of them (20%) had pathological complete response (pCR). The G3 AEs were diarrhea, ileus, thrombocytopenia, urosepsis, procedural haemorrhage, wound complication, hypokalaemia, and myalgia (all in 3.1%). No G4 AE were observed. The results of CT scans for nanoparticles dispersion demonstrated PEP503 remained within the tumor without leakage to the surrounding healthy tissues, before and after CCRT. In most patients, hafnium was not detected or below the Lower Limit of Quantification (LLOQ) in the circulation 60 minutes after PEP503 injection and was not found in urine. Conclusions: A single intratumoral injection of PEP503 in locally advanced or unresectable rectal adenocarcinoma undergoing capecitabine or 5-FU based CCRT is feasible and safe. The preliminary observed efficacy results may warrant further examination in larger clinical studies. Clinical trial information: NCT02465593.
Advances in spiral computerized tomography (CT) have made rapid biphasic contrast-enhanced CT possible. This study evaluated the capability of biphasic contrast-enhanced spiral CT to detect ...hepatocellular carcinoma (HCC). A total of 125 patients (68 men and 57 women) with proven HCC underwent preliminary noncontrast (NC) scanning, followed by hepatic arterial phase (HAP) and portal venous phase (PVP) imaging. Contrast medium (80 mL, 300 mgI/mL) was administered routinely at a rate of 2 mL/second using an automated contrast injector under guidance software monitoring. Study of NC and PVP images without concurrent study of HAP images detected 131/171 (76.6%) cases of HCC. In contrast, combined study of NC, PVP, and HAP images detected 153/171 (89.5%) cases of HCC. Thus, combined study of NC and biphasic images was able to detect an additional 12.9% of HCC cases in comparison with conventional study of NC and PVP images only. All HCCs that were detectable only on HAP imaging were enhanced homogeneously with contrast medium during the arterial phase.
子宮肌瘤是婦女常見之良性腫瘤，以往大部分的治療方法是使用手術治療。磁振導航超音波手術是過去幾年來用來治療子宮肌瘤之新方法，主要是以高能聚焦超音波將能量聚焦於病變組織，使組織造成凝固性壞死。本文報告三位罹患子宮肌瘤之婦女，在接受磁振導航超音波手術治療3個月後，其肌瘤體積變化及症狀嚴重度之改善情形。
...本研究募集三位罹患子宮肌瘤之婦女，平均年齡為38.3歲。在治療前以磁振造影來評估子宮肌瘤之體積，並以Uterine Fibroid Symptoms and Quality and Life Questionnaire(UFSQOL)問卷來計算其症狀嚴重度分數。在治療3個月後，同樣再測量一次肌瘤之體積，並再做一次問卷以計算症狀嚴重度分數，以評估磁振導航超音波手術對於子宮肌瘤之治療效果。
結果顯示，三位病患在接受治療後，皆無嚴重副作用之發生。在進行治療3個月後，三位病患之平均肌瘤體積下降30.8%，而平均症狀嚴重度分數則下降30.6%。
以磁振導航超音波手術來治療子宮肌瘤是一安全且有效之治療方法。本研究也建議一個較長期且較多病患數之研究是必要的。
碩士
國立中山大學
大陸研究所
94
Abstract
This thesis mainly researches in the Internet development and impact of Mainland China. With the theory of corporatism, it also analyzes the development of internet and ...how the control measures of the Communist Party of China change the relation between state and society .
This thesis has reviewed why the Communist Party of China developed the Internet and its restrictions and present situation of Internet. However, the Internet users have tried everything to obtain the unaccessible message. Recently, every leader of the Communist Party of China has declared for the development of Internet sequentially. At the same time, they still insist the restriction of Internet and even aggravated it with the technology of western network information corporations.
In the past two years, the Mainland China has established the association of China Internet made up of Internet Services Providers as a medium to control increasing Internet users by staging self-control actions and settin report pro
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