Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Atezolizumab

Individuals diagnosed with advanced hepatocellular carcinoma and treated with atezolizumab-bevacizumab between the ages of 18-80 were included. According to the recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, patients with comorbidities were excluded.

Atezolizumab and bevacizumab are administered every three weeks, and before to the second treatment cycle, blood tests and imaging tests are conducted (week 5). This precedes the standard response evaluation (week 9-12).

Early response evaluation

Jeong-Hoon Lee, MD PhD

Hyunjae Shin, MD

Jeong-Hoon Lee, M.D., Ph.D.

The prognosis of hepatocellular carcinoma is poor compared to other carcinomas. Many drugs have recently been developed, and recently, atezolizumab-bevacizumab treatment was superior to sorafenib, the conventional treatment for advanced hepatocellular carcinoma. However, there is no information on the evaluation on the evaluation of treatment response for atezolizumab-bevacizumab combination therapy compared to atezolizumab alone or bevacizumab alone. Therefore, this study aimed to create a predictive model that can detect treatment response at an early stage.

Ate-Bev Early Response Prediction Model in Advanced HCC

Developing Atezolizumab-Bevacizumab Treatment Response Early Prediction Model in Advanced Hepatocellular Carcinoma Patients

the index date is the date of treatment with atezolizumab and bevacizumab, and the event is either death or tumor progression of the tumor.

the index date is the date of treatment with atezolizumab and bevacizumab, and the event is death.

Seoul National University Hospital

Professor

Hematinics

Fluorodeoxyglucose F18

Liver Extracts

Sorafenib

Radiopharmaceuticals

Hepatocellular carcinoma patients not candidates to local and/or curative treatment and an expected overall survival of at least three months and who are susceptible of receiving sorafenib therapy.

Patients receive fludeoxyglucose F 18 (\^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.

Positron emission tomography with fludeoxyglucose F 18

Roberto A. Pazo Cid, MD

Positron emission tomography (PET) with \[18F\]fluorodeoxyglucose (FDG-PET) evaluates cancer cell glycolysis(Warburg effect) as a surrogate for tumor response.The hypothesis of this study is that early changes in FDG-PET signal can predict sorafenib response in hepatocellular carcinoma (HCC).

Hepatocellular carcinoma (HCC) is a major health issue worldwide, particularly in Asia and Africa, and a disease that has increased in incidence in the Western world over the past 20 years primarily as a result of the prevalence of hepatitis C virus infection, which predisposes patients to HCC.

Sorafenib (a new oral potent multikinase inhibitor directed against both tumour proliferation and angiogenesis) can be considered standard of care for patients with advanced and metastatic HCC who are not candidates for curative or locoregional therapies. Clinical benefit has been shown in 75% of patients with advanced HCC.

PET is a noninvasive imaging technique which might be an effective tool for evaluating sorafenib treatment in HCC. The aim of this study is to evaluate this new treatment with PET with fluorodeoxyglucose (FDG), since the use of only computed tomography (CT) measurements can be questioned. Our hypothesis is that early effects of sorafenib treatment in advanced HCC can be detected and quantified by PET-CT after one month of treatment. We try to reveal a decrease in tumour glucose uptake at one month and correlate it with other radiologic findings (measured by CT and diffusion-weighted nuclear resonance imaging) and the more clinically relevant endpoints clinical benefit and overall survival.

Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma

The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.

Changes in the SUVmax during treatment (SUVmax) were determined by the following equation: (post-treatment SUVmax - baseline SUVmax)/baseline SUVmax, expressed in percentage. The SUVmax for all target lesions were averaged(mSUVmax) and reported per the 1999 European Organisation for Research and Treatment of Cancer recommendations.

Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Fondo de Investigacion Sanitaria

Carlos III Health Institute

Spanish National Health System

Aragon Health Science Institute

Hospital Miguel Servet

Rare Diseases

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Metabolic non-responders, with a SUV decrease of less than 35%, discontinue induction chemotherapy and proceed to an intensified radiochemotherapy treatment

neoadjuvant radiochemotherapy in metabolic non responders

Sylvie Lorenzen, MD

Prospective, single-center, nonrandomized, explorative imaging study evaluating the value of PET as a predictor of histopathological response in metabolic non-responders Patients with resectable AEG (adenocarcinoma of the esophagogastric junction) type I and II (cT3/4 and/or cN+ and cM0)

Metabolic non-responders, showing a \<35% decrease of SUV (standardized uptake value) two weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to intensified taxane-based RCT (radiochemotherapy) before surgery. 18FDG-PET scans will be performed before (=Baseline) and after 14 days of standard neoadjuvant therapy as well after the first cycle of Taxotere/Cisplatin chemotherapy (=PET1) and at the end of intensified radiochemotherapy (PET2).

Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV). The percentage difference Delta SUV=100(SUVBaseline-SUVPET1)/ SUVBaseline will be calculated and assessed as an early predictor of histopathological response. In a secondary analysis, the association between the difference SUVPET1 - SUVPET2 and histopathological response will be evaluated.

The HICON trial is a prospective, single-center, nonrandomized, explorative imaging study evaluating the value of PET (Positron emission tomography) as a predictor of histopathological response in metabolic non-responders Patients with resectable AEG (adenocarcinoma of the esophagogastric junction) type I and II, staged cT3/4 and/or cN+ and cM0 by endoscopic ultrasound, spiral CT or MRI and FDG-PET are eligible. Tumors must be potentially R0 resectable and must have a sufficient FDG-baseline uptake. Only metabolic non-responders, showing a \<35% decrease of SUV (standardized uptake value) two weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to intensified taxane-based RCT (chemoradiotherapy (45 Gy) before surgery. 18FDG-PET scans will be performed before (=Baseline) and after 14 days of standard neoadjuvant therapy as well after the first cycle of Taxotere/Cisplatin chemotherapy (=PET1) and at the end of intensified radiochemotherapy (PET2). Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV). The percentage difference Delta SUV=100(SUVBaseline-SUVPET1)/ SUVBaseline will be calculated and assessed as an early predictor of histopathological response. In a secondary analysis, the association between the difference SUVPET1 - SUVPET2 and histopathological response will be evaluated..

Sequential FDG-PET (Positron Emission Tomography) and Induction Chemotherapy in Locally Advanced Adenocarcinoma of the Esophagogastric Junction (AEG)

Sequential FDG-PET (Positron Emission Tomography) and Induction Chemotherapy in Locally Advanced Adenocarcinoma of the Esophagogastric Junction (AEG): The Heidelberg Imaging Program in Cancer of the Oesophago-gastric Junction During Neoadjuvant Treatment: HICON Trial

The primary objective of the study is to evaluate the change in metabolic response - as measured by the relative difference delta SUV=100(SUVBaseline-SUVPET1)/ SUVBaseline in 18F-FDG uptake after 1 cycle of intensified taxan-based chemotherapy (PET1) - relative to the 18F-FDG uptake at the baseline examination, as a predictor of histopathological response in metabolic non-responders (assessed by PET 14 days after the start of neoadjuvant therapy).

investigation of the distribution of change in tumor metabolism measured with PET Baseline and PET1(∆SUV = 100 (SUVBaseline - SUVPET1) / SUVBaseline) during the treatment in histological responders and non-responders according to the Becker Score (Histomorphology and grading of regression)

accuracy of the binary prediction rule delta SUV \>65% vs. \<65% (reduction in the tumor metabolism \>65% vs. \<65 % between PET Baseline and PET1 in correlation with the histopathological regression accoring to the Becker Score

association between tumor metabolism before/after radiochemotherapy (∆SUV = 100 (SUVPET1 - SUVPET2) / SUVPET1) and histopathological response according to the Becker Score (histomorphology and grading of regression)

association between change in tumor metabolism between PET Baseline and PET 1 (∆SUV = 100 (SUVBaseline - SUVPET1) / SUVBaseline)and overall survival as well as disease-free survival

National Center for Tumor Diseases, Heidelberg

Symptoms and General Pathology

Neoplastic Cells, Circulating

Evaluation and enumeration of circulating Tumor cells from the blood with two different CTC-detection platforms: one established test (CellSearch) and one experimental test (ScreenCell).

Control diagnostic test: CT-Scan of the Chest and the Abdomen, Endoscopy and Endosonography, Clinical response and histo pathologic response. (% Of vital tumor Cells in the histologic specimen).

Blood Test for CTC evaluation

Birte Kulemann, Dr. med.

To investigate the feasibility of evaluation of prevalence and clinical significance and relevance of circulating tumor cells (CTC) in the blood of patients with resectable adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. The primary hypothesis is that the number of CTC correlates with tumor burden and response to treatment. One established and one experimental CTC detection platform will be investigated. Investigators will evaluate the prevalence and enumeration of CTC before neoadjuvant treatment (time point 1), after neoadjuvant treatment \& before operation (time point 2) and after the operation (time point 3). Results will be compared with healthy controls (one time point) and correlated with conventional response to treatment evaluation. The persistent presence of CTC could be a marker for worse response to treatment and predict early recurrence.

Little is known of the prevalence and clinical relevance of CTC in EAC, with the available data arising from heterogeneous patient populations using varied detection methods; but they are promising tools to improve staging and prediction of treatment response to perioperative and operative therapy.

The limited reports on resectable EAC use the epithelial-antibody dependent CellSearch method for CTC isolation and report a CTC-positivity rate of only 15-18% in non-pre-treated patients but with clinical relevance. It is thus needed to evaluate the relevance of CTC in the context of multimodal treatment courses.

This pilot study will investigate the CTC in the blood of patients with resectable EAC treated with multimodal therapy. Data on prevalence and enumeration of CTC will be generated. Two CTC isolation methods will be investigated, the established and expensive surface-antibody-dependent CellSearch method, and the antibody-independent and less expensive isolation by size (ISET; ScreenCell) method. The ISET method will additionally be investigated in healthy controls to get data on specificity.

The study can accomplish several goals through the use of two CTC detection platforms: 1) to determine the prevalence and number of CTC in resectable EAC under multimodal treatment, and 2) to investigate the potential role of CTC in predicting response to treatment and prognosis before neoadjuvant treatment, after neoadjuvant treatment and before operation as well as after the operation.

The primary hypothesis is that the enumeration of the CTC correlates with tumor burden and will reflect the response to treatment. To date the response to treatment is assessed with a combination of CT-morphologic, endoscopic, clinical (dysphagia) and finally histology. This assessment is used as control.

Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC

Resectable Esophageal Adenocarcinoma: The Influence of Multimodal Therapy on the Prevalence and Enumeration of Circulating Tumor Cells in Comparison With Conventional Response Evaluation in a Feasibility Study

The overall survival will be correlated with the number of CTC at the different timepoints.

The progression free survival will be correlated with the number of CTC at the different time points.

Number of patients with detectable CTCs isolated with the ISET device compared to the CellSearch method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ate-Bev Early Response Prediction Model in Advanced HCC	NCT05763277	Hepatocellular ... Atezolizumab-be... Response Evalua...	Early response ...	18 Years - 80 Years	Seoul National University Hospital
Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma	NCT01157013	Hepatocellular ...	Positron emissi...	18 Years -	Hospital Miguel Servet
Sequential FDG-PET (Positron Emission Tomography) and Induction Chemotherapy in Locally Advanced Adenocarcinoma of the Esophagogastric Junction (AEG)	NCT01271322	Adenocarcinomas...	neoadjuvant rad...	18 Years - 75 Years	National Center for Tumor Diseases, Heidelberg
Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma	NCT01157013	Hepatocellular ...	Positron emissi...	18 Years -	Hospital Miguel Servet
Ate-Bev Early Response Prediction Model in Advanced HCC	NCT05763277	Hepatocellular ... Atezolizumab-be... Response Evalua...	Early response ...	18 Years - 80 Years	Seoul National University Hospital
Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC	NCT02610764	Esophageal Aden...	Blood Test for ...	18 Years -	University Hospital Freiburg
Sequential FDG-PET (Positron Emission Tomography) and Induction Chemotherapy in Locally Advanced Adenocarcinoma of the Esophagogastric Junction (AEG)	NCT01271322	Adenocarcinomas...	neoadjuvant rad...	18 Years - 75 Years	National Center for Tumor Diseases, Heidelberg

Spots Global Cancer Trial Database for response evaluation