Safety and Efficacy Evaluation of IM83 CAR-T Cells for Patients With Advanced Liver Tumors
Liver CancerThis is a open-label, single center, cohort study to determine the efficacy and safety of IM83 CAR-T cells in patients with advanced Liver Tumors.
Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
Colon Cancer Liver MetastasisThe purpose of this study was a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion
A New Track Ablation Device for Liver Biopsy: A Feasibility Study
Liver NeoplasmsThe purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.
Autologous Natural Killer T Cells Infusion for the Treatment of Cancer
Breast CancerGlioma5 moreThe purpose of this study is to assess the safety and effectiveness of natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.
Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients...
Colorectal CancerKRAS Wildtype1 moreUp to 50% of patients with colorectal cancer (CRC) develop liver metastasis during the course of their disease. In 30-40% of patients metastasis is confined to the liver. In these patients R0-resection of metastases may contribute to marked improvement of overall survival. Primary resection of liver metastasis is possible in about 15-20% of patients (Scheele 2005, Petrelli 2005). Recent studies indicate that perioperative chemotherapy may improve survival after resection of liver metastases (Portier 2007, Nordlinger 2007). Nevertheless, there is evidence that 70-80% of patients have recurrent disease after resection of liver metastasis. Stratification for the risk of recurrence may be performed using the FONG-score (Fong 1999). This study is designed to investigate the efficacy of postoperative chemotherapy combined with an anti-EGFR treatment using panitumumab. The majority of patients present to the surgeon after chemotherapeutic pretreatment with various not necessarily standardized regimens. Also postoperative therapy after resection of liver metastasis is not a clearly defined standard of care in Germany. Based on the study by Nordlinger et al. an oxaliplatin-based regimen is chosen for postoperative therapy (Nordlinger 2008). For reasons of practicability mFOLFOX6 was selected as the chemotherapy backbone for additive treatment (Allegra 2010). Also, there is evidence that the combination of FOLFOX with panitumumab is associated with enhanced antitumor activity (Douillard et al. ESMO 2009). The experimental treatment arm will therefore evaluate the combination of FOLFOX plus panitumumab. Since in colorectal cancer monoclonal antibodies directed against the EGFR are not active in KRAS mutant patients, the experimental arm including panitumumab will only be performed in KRAS wild-type patients (Amado 2008). The planned study aims to assess the efficacy of postoperative therapy with FOLFOX plus panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by a randomised control group without the antibody. (Figure 1: Study Design). The study will allow preoperative treatment with regimens such as FOLFIRI, XELIRI, FOLFOX or XELOX +/-bevacizumab or +/- cetuximab. However, only those patients will be considered eligible who did not progress during preoperative therapy. After surgery, a treatment-free interval of at least 4 weeks, but no longer than 8 weeks will be granted. KRAS-wild-type patients (60% of all pts) will then be randomized in a 2:1 ratio to an experimental arm with FOLFOX + panitumumab or to a reference arm with FOLFOX alone. Combination treatment will be performed for a duration of 3 months, after which patients in the experimental arm will receive maintenance therapy with panitumumab for further 3 months. In the reference arm, treatment will, however, be ended after 3 months.
Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic...
Metastatic Breast CancerLiver MetastasesThis is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Only patients with limited extrahepatic disease are included.
Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies...
Hepatocellular CancerNon-small Cell Lung Cancer2 moreTumour angiogenesis has been identified to play a critical role in tumour growth and this knowledge has led to the identification of new targets for cancer therapy. Multiple angiogenic factors are involved in the regulation of angiogenesis, among them VEGF (vascular endothelial growth factor) and its receptor are of crucial relevance. The inhibition of VEGF signaling by monoclonal antibodies or small molecules (kinase inhibitors) has already been successfully established for the treatment of different cancer entities and multiple new drugs are being tested in clinical trials. The ever-expanding list of antiangiogenic agents being available in the near future will raise the questions when to use which agent and in which sequence. As a consequence biomarkers are going to be indispensible tools for choosing the most effective drugs and to predict dosing and resistance. The present project is based on an academic clinical trial in which patients suffering from different cancer types (colorectal cancer, non-small cell lung cancer, renal cell cancer and hepatocellular cancer) treated routinely with antiangiogenic agents will be included. Consecutive serum and blood probes will be taken and will be examined and correlated with functional imaging and the clinical course. The following parameters have been selected: soluble markers in the plasma (VEGF, bFGF, ICAM, sVGFR-2 IL-8, SDF1 and Dickkopf 3) and cellular parameters like circulating endothelial cells (CEC) and circulating endothelial progenitor cells (CEPs). In conclusion, the present project is screening for potential biomarkers and biomarker combinations relevant for antiangiogenic drugs in different tumour types. The predictive value of such profiles should then be evaluated in larger cohorts. In the future such profiles could possibly help clinicians to use these agents more effectively and therefore also more economically.
Study of Tranexamic Acid for Reducing Blood Requirement in Patients Undergoing Major Gastro-intestinal...
Gastric CancerPancreatic Cancer2 morePrimary objective of the study is to compare requirement of blood transfusion and mortality in patients receiving Tranexamic acid (Cyklokapron®) and those not receiving it. Secondary objective is to; assess the re-bleeding events; need for surgical intervention; length of stay in Intensive care unit in between the two groups.
TACE as an Adjuvant Therapy After Radiofrequency Ablation (RFA) for Hepatocellular Carcinoma
Hepatocellular CarcinomaLiver CancerThe purpose of this study is to prospectively evaluate whether transcatheter arterial chemoembolization (TACE) will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.
Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma...
Hepatocellular CarcinomaLiver CancerThe purpose of the investigators' study is to prospectively evaluate whether low-dose thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).