View clinical trials related to Rectal Neoplasms.
Filter by:Briefly, this is a 28-day dietary intervention study participants will be asked to eat 2 ounces (52 grams) of walnuts every day for 3 weeks, and at the end of the study period they will come in for a colonoscopy. Participants will first start a 1-week run-in period where they will be asked to avoid foods high in ellagic acid. In addition, they will be asked to complete food surveys and two sets of 3-day dietary records, and to provide colon biopsies for this study during their routine colonoscopy, as well as a blood, and two urine and stool samples. Urine samples will be used for analysis of urolithin, ellagic acid metabolites. Stool samples will be used to assess gut microbiota changes after walnut consumption. Dietary records will be used for compliance and Food Frequency Questionnaire will be used to assess dietary habits. Lastly, the biopsy samples will be used for analysis of biomarkers and anti-inflammatory in the colon, as well as adherent microbiome to the colonic tissue. Data will be analyzed based on the urolithin phenotypes.
Muscle is lost as part of the rectal cancer disease process. Surgery to treat rectal cancer and its subsequent immobility leads to increased muscle loss. Neuromuscular electrical stimulation (NMES) has been shown in previous studies in the critically ill to maintain muscle mass. The investigators aim to examine whether NMES use in the pre and postoperative setting preserves muscle mass, speeds up recovery and improves outcomes in advanced rectal cancer patients undergoing curative surgery. This is a phase II double blind randomised controlled clinical trial.
This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 (Ezabenlimab) compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies. VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen together with ATP128. The Sponsor plans to enrol 96 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations: - Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies - Cohorts 1b, 2a, 2c: 30 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (4-6 months duration at minimum) - Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their disease: - Patients in Cohort 1a will receive ATP128 as single agent - Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091 - Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI 754091
The primary purpose of this registry is to prospectively collect data from different Mini-invasive Colo-rectal Units in Northern Italy with a standardization of the pre-operative, intra-operative and post operative setting for patients operated on for non metastatic rectal cancer with curative intent. The secondary aim is to collect in a registry the compliance to oncological treatments and the oncological outcomes for the same patients
This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.
Rectal cancer represents 14,000 new cases a year in France. At diagnosis, 70% of patients have a locally advanced tumors T3-T4 and / or N + evaluated mainly by rectal MRI. These patients will benefit from a neo-adjuvant treatment by radio-chemotherapy. The complete histologic response rate (ypT0N0) after this neo-adjuvant treatment ranged from 15 to 27% and improved recurrence-free survival, remotely relapse-free survival, overall survival, and decreased local recurrence rate. In the case of full response diagnosis after neoadjuvant chemoradiotherapy 3 theoretical solutions exist: 1. Total excision of the rectum and mesorectum (TME) This is the classic attitude with a low risk of local recurrence (5%) but functional complications occur in 25 to 60% of cases 2. A simple monitoring ("Watch and Wait") by MRI, biopsy, rectoscopy ... This strategy was initially proposed to elderly patients considered inoperable but it has also been proposed in younger patients, operable, with a view to decreasing morbidity and sequelae. This attitude poses a likely overall risk of local recidivism. However, this higher risk of recurrence may be the result of imperfect identification of ypT0N0 patients. 3. Local excision of the post-radiation scar also called closure lumpectomy with pathological analysis and possible secondary TME if no complete response. This last attitude has the advantage of allowing an anatomopathological verification of the treated lesion and to complete the treatment if necessary. In the case of ypT0 the local recurrence rate is low and in this case it is possible to consider rectal savings. The choice of the last two attitudes is therefore based on the correct identification of patients in complete response. The performance of the diagnosis of no complete response after radiochemotherapy is therefore fundamental and is the subject of this project wich consist of comparing he diagnostic performance for the identification of a complete lack of response [18F] -FDG-PET / MRI ypT0N0 to that of the classic attitude (MRI) 6 to 9 weeks after the end of a neoadjuvant chemoradiotherapy treatment of low and mid-rectal cancers in patients in whom clinical and endoscopic examination favor a complete response.
The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. Studies have shown that colon pouch can reduce and alleviate LARS symptoms. However, most previous studies focused on open surgery, and the evaluation index lacked objectivity. Therefore, in the context of minimally invasive rectal cancer surgery, it is necessary to re-evaluate the value of improved surgical methods for the prevention of LARS, so as to improve the quality of life of patients.
This phase I/II trial studies the best dose and side effects of encorafenib, cetuximab, and nivolumab and how well they work together in treating patients with microsatellite stable, BRAFV600E gene mutated colorectal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Encorafenib and cetuximab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.Giving encorafenib, cetuximab, and nivolumab may work better in treating patients with colorectal cancer compared to cetuximab alone.
In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab
This is a multi-center prospective randomized controlled study. In this study, the investigators will use confocal laser endomicroscopy to make real-time in vivo optical biopsy of distal margin in rectal cancer surgery and help surgeons to make surgical decision.The investigators also assess the accuracy of CLE optical biopsy, compared with intra-operative frozen section.