View clinical trials related to Colorectal Neoplasms.
Filter by:Study description: the study is a clinical trial aimed at assessing the validity of a point-of-care tool developed for colorectal cancer screening using urine metabolites. Objectives: Primary Objective: In the pilot phase, investigators will field test the POC device in Nigeria on 75 patients who are high-risk for CRC and then validate the urine metabolite signature using a large cohort of 645 patients at high risk for CRC and polyps. This will allow us to determine the sensitivity and specificity of this device and these signatures for CRC and polyps. Endpoints: the endpoint will be the calculation of the validity (sensitivity and specificity) of the tool. Positive and negative predictive values will also be calculated. Study population: Patients > 40 years of age with LGI bleeding for more than one-week OR - Patients who are high risk due to a family history of CRC (first-degree relative) - Must be at most 10 years younger than when relative presented with CRC (For example, a patient with a relative diagnosed at age 40 with CRC will be eligible after age 30) - Patients with a diagnosis of stage I-III CRC who have no evidence of disease Both males and females will be involved in the study I. The study will evaluate the validity and acceptability of the POC biosensor device in Nigeria. Description of sites/facilities enrolling participants: the study will be conducted at Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) which hosts the head office of African Research Group for Oncology (ARGO). The study will also run concurrently at other ARGO collaborating sites. All the ARGO collaborating sites are tertiary health care facilities with experienced personnel to oversee the study. The pilot study will, however, take place in OAUTHC alone. Study duration: The accrual time for the validation study is 2.5 years. Participant Duration: the study will require initial one-time contact. Those that are positive during the screening with the POC biosensor device will be booked for colonoscopy. Hence, for participants with positive results to complete the study may require 2 weeks on average.
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies.
One of the ways that cancer grows and spreads is by avoiding the immune system.NK cells are immune cells that kill cancer cells, but are often malfunctioning in people with colorectal cancer and blood cancers. A safe way to give people with colorectal cancer and blood cancers fresh NK cells from a healthy donor has recently been discovered. The purpose of this study is to show that using two medicines (vactosertib and IL-2) with NK cells will be safe and will activate the donor NK cells. NK cells and vactosertib are experimental because they are not approved by the Food and Drug Administration (FDA). IL-2 (Proleukin®) has been approved by the FDA for treating other cancers, but the doses used in this study are lower than the approved doses and it is not approved to treat colorectal cancer or blood cancers.
Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks. ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery. Trimodal Prehabilitation Program is a recently introduced preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients. This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol. Additionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.
This phase IIA trial investigates the side effects of Ad5.F35-hGCC-PADRE vaccine and to see how well it works in treating patients with gastrointestinal adenocarcinoma. Ad5.F35-hGCC-PADRE vaccine may help to train the patient's own immune system to identify and kill tumor cells and prevent it from coming back.
This clinical trial will be conducted as a single-center, open-label, Phase I/2 trial to evaluate the feasibility and safety of Yttrium-90 radioembolization (Y90-RE) in combination with a fixed dose of of immunotherapy (durvalumab - 750 mg) in subjects with liver-predominant, metastatic colorectal cancer (mCRC), which is mismatch repair proficient/microsatellite stable (pMMR/MSS).
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic colorectal cancer (CRC) as a phase II trial
The primary aim of this study is - to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Endocuff Vision is used. Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Bevacizumab, an antibody against vascular endothelial generated factor (VEGF), combined with the fluorouracil-based chemotherapy regimens has been approved in the 1st and 2nd line treatments for metastatic colorectal cancers(mCRC). Other inhibitors of the VEGF pathway, such as Ramucirumab and Aflibercept are also approved in the 2nd line therapy. Apatinib is a small molecule tyrosine kinase inhibitor (TKI), which can highly selectively bind to and strongly block VEGF receptor 2 (VEGFR - 2), resulting in reduced cell migration, proliferation, and tumor microvascular density mediated by VEGF . In this study, the patients who have progressed following or on the first-line oxaliplatin and fluorouracil（5-FU） combined with bevacizumab are randomised into two arms(FOLFIRI plus apatinib or FOLFIRI plus bevacizumab) in the 2nd line setting. To identify specific biomarkers at the genetic and proteomic levels between two arms is the primary end point.
Currently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR, after resection of CRLM have been reported. The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to initiate protocol-directed therapy and completed median of six cycles (range, one to six). Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7 months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met the prespecified end point of higher than 85% survival at 2 years and were clinically tolerable.