Remote Monitoring in Cancer Care: A Platform Study
Head and Neck CarcinomaHematopoietic and Lymphoid Cell Neoplasm3 moreThis study investigates a device that closely monitors vital signs, as well as a smartphone application (app) that allows patients to respond to different questions and tests that will monitor for new symptoms. This study may help researchers understand if wearing the device is a better tool than standard vital sign assessment tools done only while at the doctor's office or hospital, and if using the smartphone app is a better tool than standard assessment tools used while in the doctor's office or hospital.
Spanish Series of Patients Treated With the Radionuclide Lutetium177
Neuroendocrine TumorsIntestinal Neoplasms18 moreThis study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.
Microvascular Function in Patients Undergoing 5-Fluorouracil Chemotherapy
Gastrointestinal CancerHead and Neck Cancer3 moreThe primary aim of this study is to investigate potential differences in vascular function between patients receiving 5-Fluorouracil (5-FU) chemotherapy, patients receiving chemotherapies other than 5-FU, cancer survivors who were treated with 5-FU, and an age and sex matched control. 5-FU is the third most commonly administered chemotherapeutic agent and its use is associated with the second most occurrences of cardiotoxicity. Despite the known cardiotoxic effects of 5-FU, it's effects on the human vasculature are not well understood. To achieve the goals of this project Laser Doppler flowmetry (LDF) will be used to assess blood flow within the skin microcirculation of the forearm in cancer patients who have received 5-Fluoruracil within the past 30 days (Experimental Group), cancer patients receiving radiotherapy and/or chemotherapy other than 5-Fluorouracil, and an age and sex matched control (Control Group). LDF utilizes a small (~3 cm) non-invasive sensor placed on the skin. The sensor shines light into the skin, and upon contact with red blood cells (RBCs), the light is reflected and scattered. This information is used to evaluate microvascular blood flow and has previously been used in clinical populations.
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer...
Stomach NeoplasmsGastrointestinal Neoplasms6 moreThe purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.
XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric...
CarcinomaGastrointestinal Diseases5 moreThis is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.
Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer
SarcopeniaSarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients (arginine, glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate the activity of the immune system and provide an additional benefit beyond the nutritional support, this intervention type is called immunonutrition. Despite these possible benefits, their utility has been proven in few clinical scenarios, for example in with patients with upper gastrointestinal cancer undergoing surgical resection; based on this, current guidelines recommend that patients should receive oral/enteral nutritional support with an specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides) , but there is a lack of evidence for supporting its use in other clinical conditions including patients with cancer that receive systemic treatment
A Study of SI-B003 and BL-B01D1+SI-B003 in the Treatment of Patients With Locally Advanced or Metastatic...
Esophageal CancerGastric Cancer1 moreObjective: To investigate the efficacy, safety and tolerability of SI-B003 monotherapy and BL-B01D1+SI-B003 dual agents in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal tumors, and to further explore the optimal dose and mode of combination.
Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation...
Gastric CancerEsophageal CancerThis is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of using the FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System for mapping sentinel lymph nodes (SLNs) in subjects with gastric, gastric-oesophageal junction, and oesophageal cancers, consisting of a safety lead-in phase and an expansion phase.
A Clinical Study on the Safety and Efficacy of CAR-T Therapy for the TM4SF1-positive Tumors of Digestive...
Digestive TumorTransmembrane 4 L Six Family Member 1 (TM4SF1) is highly expressed in many tumors of digestive system . The Chimeric Antigen Receptor T-cells (CAR-T) that target TM4SF1 has been generated in our good manufacturing practices (GMP) facility and the anti-tumor effects have been demonstrated in multiple in vitro and in vivo studies. Clinical studies are proposed here to evaluate the anti-tumor activity of these cell therapy products for treatment of patients with TM4SF1 positive tumors of digestive system. In this study, the safety, tolerance, and preliminary efficacy of CART-TM4SF1 cells will be examined in patients with refractory/recurrent advanced pancreatic cancer, colorectal cancer, gastric cancer or liver cancer. Clinical and immunological responses will be evaluated about 30 days and last up to 2 years after CAR-T cell infusion.
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
SarcomaGastrointestinal CancerThis prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care therapies including radiotherapy. Recent advances in treatment approaches affected disease outcomes and toxicities. Prospective monitoring of disease outcomes and toxicities using standardized assessments will provide information about recent changes in the standard of care and further refine treatment approaches and prospective clinical trial design.