View clinical trials related to Colorectal Neoplasms.
Filter by:This project plans to use CIK combined with chemotherapy, immunotherapy and targeted therapy to treat CRC patients, so as to explore the effectiveness of CIK treatment and the CRC subtypes more suitable for CIK treatment, thereby improving the survival rate and quality of life of CRC patients.
This study is a Phase 1b open-label study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of WU-NK-101 in combination with cetuximab in patients with advanced and/or metastatic CRC (Cohort 1), and in patients with advanced and/or metastatic SCCHN (Cohort 2). The overall study will be comprised of two phases, a Dose Escalation Phase, and a Cohort Expansion Phase.
The Phase IIa of this clinical study, a dose-escalation study of IAH0968 in combination with CAPEOX, is designed for safety and tolerability in subjects with HER2-positive advanced or metastatic solid tumors. Phase IIb/III is an operational seamless adaptive design consisting of two phases. Phase I (Phase IIb) was designed to initially evaluate the efficacy and safety of IAH0968+CAPEOX in HER2-positive subjects with metastatic colorectal cancer, using PFS.
This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.
This phase I/II trial tests how well botensilimab, balstilimab, and regorafenib works in treating patients with microsatellite stable colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who have progressed on prior chemotherapy. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib binds to and inhibits growth factor receptors, which may inhibit the growth of new blood vessels that tumors need to grow. Giving botensilimab, balstilimab, and regorafenib in combination may work better in treating patients with metastatic colorectal cancer than giving these drugs alone.
Hepatic metastases of colorectal cancer (CRC) are partially necrotic tumors mainly vascularized by the hepatic artery. When resectable, these metastases must be removed with a safety margin of 1 mm. Resection margins greater than 1 cm are associated with better disease-free survival and no local recurrence. Thermoablation systems allow for ablation zones of approximately 4.5-5 cm in diameter. For tumors <3 cm, subject to perfect targeting, it is possible to obtain ablation margins of 1 cm, which would greatly reduce the local recurrence rate. Accurate assessment of these tumor boundaries and characterization of these margins are paramount to ensure complete ablation. Thermoablation for these small liver metastases (<3cm) has shown equivalent efficacy to surgery in terms of recurrence and survival with fewer complications. Thermoablation treatment is indicated for patients with stable disease undergoing chemotherapy. This leads to liver remodeling and metastases become difficult to see on ultrasound and CT scans. The study authors hypothesize that the porto-scanner guidance technique with Angio-CT for thermoablation treatment of CRC liver metastases will allow a better exploration of these metastases by allowing a better identification of the margins and thus ensure a more accurate and complete treatment for patients.
International guidelines recommend deciding the treatment of colorectal lesions based on the estimated histology by endoscopic optical diagnosis. However, the theoretical and practical knowledge on optical diagnosis is not widely expanded The mail goal of this randomised controlled trial is to compare the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps > 20 mm assessed in routine colonoscopies of gastroenterologists attending a e-learning module (intervention group) vs gastroenterologists who do not (control group) The main questions the study aims to answer are: - Is the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module? - Is the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps ≥ 20 mm assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module? - In lesions with submucosal invasion, is the en bloc and complete resection rate (R0) increased in those gastroenterologists participating in the e-learning module? - In lesions referred to surgery, is the pooled benign polyps rate decreased in those gastroenterologists participating in the e-learning module? - In lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection), is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in those gastroenterologists participating in the e-learning module? - In lesions treated with piecemeal endoscopic resection, is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in those gastroenterologists participating in the e-learning module? - Is the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures increased after participating in the e-learning module? The participants (or subjects of study) are gastroenterologists. They will be randomised to do the e-learning course (intervention group) or not (control group). Researchers will compare clinical outcomes of gastroenterologists participating in the e-learning module vs gastroenterologists not participating in the e-learning module to see if: - the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps > 20 mm assessed in routine colonoscopies is increased. - the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps > 20 mm is increased. - the en bloc and complete resection rate (R0) is increased in lesions with submucosal invasion. - the pooled benign polyps rate decreased in lesions referred to surgery. - the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection). - the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in lesions treated with piecemeal endoscopic resection. - the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures after participating is increased.
This clinical trial studies how well a web-based dyadic intervention works to manage psychoneurological symptoms for patients with colorectal cancer and their caregivers. Patients with colorectal cancer receiving chemotherapy experience severe and distressing psychoneurological symptoms that include fatigue, depression, sleep disturbance, pain, and cognitive dysfunction. When these co-occurring symptoms are undertreated, they negatively affect functional status, survival rates, and quality of life of patients as well as decrease health outcomes of their family caregiver. A critical need exists to develop an effective and novel intervention that focuses on patients with colorectal cancer receiving chemotherapy and their caregivers. A web-based dyadic intervention holds great promise to reduce psychoneurological symptoms burden and improve quality of life for patients with colorectal cancer receiving chemotherapy and advance intervention development and implementation in cancer supportive care and health equity.
Worldwide, there are 1,361,000 new cases of colorectal cancers (CRC) annually, with 694,000 deaths. However, the incidence varies by up to a factor of 10x between high and low incidence countries (eg. USA vs Mexico, incidence rate of 42.54 vs 7.44 / 100,000 inhabitants). Mexico is considered a low-incidence country, with 8,651 new cases and 4,694 deaths annually. CRC is a preventable and detectable disease. Screening programs established in high-incidence countries have managed to reduce the incidence and mortality from this disease and it is considered a cost-effective strategy. In less developed countries where there are no screening programs for CRC, the highest number of deaths occurs despite having the lowest number of cases. It is recognized that a barrier to establishing a screening program in a country with low incidence and limited resources is cost-effectiveness. The prevalence of Advanced Colorectal Neoplasia (ACN) detected by screening colonoscopy in a Mexican cohort of 1172 INNSZ patients was 2.9%. In the US the prevalence is 7.6%. The number of colonoscopies to be performed to detect ACN was estimated at 34 for Mexico and 13 for the US, which suggests that the cost-effectiveness of screening colonoscopy could be 3 times lower in our country. In Mexico there is no national screening program for CRC. The eligible population (adults between 50 and 75 years old) for CRC screening is estimated in 20 million of Mexicans. It is recognized that Mexico does not have enough financial resources nor the infrastructure to screen the entire eligible population either by direct colonoscopy, or by FIT (fecal immunochemical test) followed by colonoscopy. With a 5% frequency of positive FIT, nearly 1,000,000 follow-up colonoscopies would be required annually in a population screening program. An alternative could be to offer screening based on risk, which means only offering screening to the highest-risk population. There are calculators to predict the risk of identifying ACN in a screening colonoscopy, however, none have been developed and validated in the Mexican population. The weight of the risk factors associated with ACN in the Mexican population could be different, so it is necessary to develop and validate an ACN risk calculator that allows the Mexican population to be stratified and to concentrate screening efforts on the population at highest risk.
This is an open-label, multicenter, randomized parallel-group phase 2 study evaluating the efficacy and safety of Fruquintinib alternating with Bevacizumab plus Capecitabine versus Bevacizumab plus Capecitabine as maintenance therapy following first-line treatment for metastatic colorectal cancer. Approximately 40 patients with metastatic colorectal cancer who have achieved partial remission after completing 8 cycles of standard first-line chemotherapy (FOLFOX combined with Bevacizumab) but are still in un-resectable state will be assigned to 2 maintenance treatment groups by randomization in a 1:1 ratio to receive Fruquintinib alternating with Bevacizumab plus Capecitabine (Arm A) or Bevacizumab plus Capecitabine (Arm B). The study contains a safety lead-in phase in which the safety and efficacy of Fruquintinib alternating with Bevacizumab plus Capecitabine will be assessed in approximately 20 patients. All patients from Arm A and Arm B will be treated until unacceptable toxicity, withdrawal of informed consent, death, or other criteria for ending the study (whichever occurs earlier). The study will evaluate PFS, ORR, DCR, OS and safety.