Neuroendocrine Tumors

Liver Metastases

Single-photon emission computed tomography (SPECT) imaging will assess 99mTc-MAA (MAA being macro aggregated albumin) deposition in the tumour bed to estimate the dose of radiation to tumour and healthy tissue, before administration of TheraSpheres to eligible patients

TheraSpheres Selective Internal Radiation Therapy (SIRT)

Imperial College NHS Trust

TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours With Liver Mets

A Phase II Assessment of the Safety and Efficacy of TheraSphere® Selective Internal Radiation Therapy (SIRT) in the Treatment of Metastatic (Liver) Neuroendocrine Tumours (NETs)

Record incidence of adverse events overall and by severity, as well as serious adverse events using the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) for Adverse Events, version 4.03 (CTCAE V4.03)

This is the best overall response (CR+PR) determined by RECIST 1.1

Determined by RECIST 1.1 and defined as date of treatment to the date of first documentation of disease progression

Date of randomisation to the date of death from any cause, or censored at date of last contact

Evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 (Quality of Life Questionnaire type C30) at baseline, week 8 and 3 monthly thereafter

- Evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-I.NET21 (Quality of Life Questionnaire, type I.Neuroendocrine Tumour number 21) at baseline, week 8 and 3 monthly thereafter

Patients will have a liver CT scan at baseline, 12 weeks post SIRT, 3 monthly thereafter and at disease progression - results will be compared to patient clinical data

Blood samples will be collected at screening, week 8, week 12 and at disease progression for ctDNA analysis

Imperial College London

Biocompatibles UK Ltd, a BT International group company

patients with HBV induced cirrhosis will be recruited for study, which involved a 4 times intestinal microbiota transplant and the time interval is generally 2 weeks.

Cirrhosis, Liver

All participants take 4 times IMT by gastroduodenoscopy with 2-week intervals

intestinal microbiota transplant

Zhongshan Hospital Affiliated to Xiamen University

Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis

A Randomised Study on Intestinal Microbiota Transplantation for Hepatitis B Virus Induced Cirrhosis

Fibroscan score of liver fibrosis and steatosis

The onset and duration of gastrointestinal symptoms will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".

The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) in fecal samples from recruited patients.

Doppler ultrasonography is medical ultrasonography that employs the Doppler effect to generate imaging of the movement of tissues and body fluids (usually blood), and their relative velocity to the probe. By calculating the frequency shift of a particular sample volume, for example flow in an artery or a jet of blood flow over a heart valve, its speed and direction can be determined and visualized. Color Doppler is the presentation of the velocity by color scale. Color Doppler images are generally combined with grayscale (B-mode) images to display duplex ultrasonography images, allowing for simultaneous visualization of the anatomy of the area. This is particularly useful in cardiovascular studies (sonography of the vascular system and heart) and essential in many areas such as determining reverse blood flow in the liver vasculature in portal hypertension.

A CT scan, also known as computed tomography scan, makes use of computer-processed combinations of many X-ray measurements taken from different angles to produce cross-sectional (tomographic) images (virtual "slices") of specific areas of a scanned object, allowing the user to see inside the object without cutting. Other terms include computed axial tomography (CAT scan) and computer aided tomography.

Hepatobiliary MR is used to detect and characterize lesions of the liver, pancreas, and bile ducts. Focal or diffuse disorders of the liver may be evaluated using diffusion-weighted, opposed-phase imaging, and dynamic contrast enhancement sequences. Extracellular contrast agents are used widely in liver MRI and newer hepatobiliary contrast agents also provide the opportunity to perform functional biliary imaging.

Zhongshan Hospital Xiamen University

144 patients spread urea cream (urea 20%)

144 patients spread placebo cream (urea 0%)

Hepatocellular Carcinoma

Sorafenib 400mg (twice daily), Spread urea cream (urea 20%)

Urea Cream 20%

Sorafenib 400mg (twice daily), Spread placebo cream (urea 0%)

Placebos

Korea University Guro Hospital

The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction

The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction in Patients With Korean Hepatocellular Carcinoma Patients: Multicenter, Prospective Randomized Double-Blind Controlled Study

Comparison of cumulative incidence of HFSR between placebo group and urea cream group

Comparison of cumulative incidence of severe HFSR (grade 2 or grade 3) between placebo group and urea cream group

Comparison of incidence of dose reduction or discontinuation of sorafenib due to HFSR on each group

Assessment of QOL related to HFSR using The Hand-Foot Skin Reaction and Quality of Life Questionnaire (HF-QoL) scoring system. HF-QOL instrument comprises a 20-item symptom scale and an 18-item daily activity scale. Each item was scored from 0 (not at all) to 4 (always or extremely). Therefore, the range of score for HF-QoL was from 0 to 152 points. (Ref. Anderson et al. The Oncoligist 2015;20:831-838)

The occurrence rate of other side effect excluding HFSR

Comparison of incidence of HFSR on 2, 4, 8, and 12 weeks between placebo group and urea cream group

liver neoplasms/fatigue

TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours With Liver Mets

Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis

The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction

Long-Term Lamivudine Therapy for Chronic Hepatitis B

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