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Metastatic Colorectal Cancer clinical trials

View clinical trials related to Metastatic Colorectal Cancer.

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NCT ID: NCT06202183 Not yet recruiting - Colorectal Cancer Clinical Trials

Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial

Start date: June 2024
Phase: N/A
Study type: Interventional

This research study is a randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer. The names of the study groups involved in this study are: - Exercise - Waitlist Control

NCT ID: NCT06202001 Recruiting - Clinical trials for Metastatic Colorectal Cancer

Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients

Start date: October 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

In mCRC, response to second-line chemotherapy is limited, and few treatment options are available. It is urgent to design an optimal second-line treatment regimen to improve the response rate and prolong the survival of patients with mCRC. Several studies preliminarily demonstrated that irinotecan, TAS-102 plus bevacizumab regimen could bring promising efficacy with a tolerable safety profile for patients with mCRC as a second-line treatment. This phase I/II study was aimed to determine the recommended phase II dose (RP2D) of the combination of TAS-102, irinotecan, and bevacizumab for future clinical trials in patients with mCRC refractory to both fluoropyrimidine and oxaliplatin and to evaluate its safety and preliminary efficacy.

NCT ID: NCT06195670 Not yet recruiting - Clinical trials for Metastatic Colorectal Cancer

Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC

Start date: January 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.

NCT ID: NCT06195111 Not yet recruiting - Clinical trials for Metastatic Colorectal Cancer

A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)

Start date: March 1, 2024
Phase:
Study type: Observational

A real-world study of trifluridine/tipiracil containing regimen for the treatment of patients with metastatic colorectal cancer. A total of 200 patients planned to be enrolled.

NCT ID: NCT06191120 Not yet recruiting - Clinical trials for Metastatic Colorectal Cancer

FAPI Molecular Imaging for Diagnosis of the CMS4 Unfavorable Colorectal Cancer Subtype

FoCus
Start date: April 2024
Phase: N/A
Study type: Interventional

Colorectal cancer (CRC) is the 3rd most common cancer worldwide and accounts for ~14,000 new diagnoses and ~5,000 deaths in the Netherlands yearly (1.9 million and 935 thousand on a global level). Large scale transcriptional profiling of primary CRC tumors has revealed the presence of four distinct consensus molecular subtypes (CMSs). The CMS4 subtype is associated with a poor prognosis, especially in early CRC, and may benefit less from several standard systemic treatments (e.g. oxaliplatin, 5-fluorouracil, cetuximab), while being relatively sensitive to irinotecan. This is relevant as in the metastatic setting often the first choice first-line systemic therapy regimen is oxaliplatin and not irinotecan-based. Furthermore, tumor cells can acquire a CMS4 phenotype following exposure to chemotherapy, which may contribute to therapy resistance. CMS4 accounts for ~25% of all early-stage CRC patients and is more prevalent in advanced disease stages (~40% in stage IV CRC). Currently available CMS4 diagnostic tests require tumor tissue samples. The interpretation of biopsy-based CMS4 diagnosis is however complicated by large intra- and inter-lesion heterogeneity of CMS4 status. Extensive biopsy protocols could address the problem of CMS4 heterogeneity but are challenging in routine clinical practice. The development of CMS4-targeted therapy strategies therefore requires a more robust and clinically applicable diagnostic test for comprehensive quantitative assessment of CMS4 status of all lesions - primary and metastatic - in individual cancer patients. A promising solution for such a diagnostic test is to use a radiotracer that enables the quantitative assessment of CMS4 in vivo by whole body molecular imaging. This technique is particularly suited to assess biomarkers with heterogeneous expression: for diagnostic purposes, as a companion diagnostic for (targeted) therapies, or as part of a 'theranostic' strategy where patient selection using the diagnostic radiotracer is followed by treatment with the same tracer labeled to a therapeutic compound. Radiolabeled fibroblast activating protein inhibitor (FAPI) is an emerging diagnostic radiotracer that allows the comprehensive whole-body, whole-tumor assessment of fibroblast activation protein (FAP) expression in humans with a very low background uptake also at frequent CRC metastatic sites including the liver. FAP is an excellent candidate molecular imaging target for CMS4, as it is highly expressed on cancer-associated fibroblasts (CAF) that are abundantly present in this CRC subtype. Indeed, the investigators found that FAP gene-expression measured in tumor biopsies - as a single marker - accurately discriminates CMS4 from other CRC subtypes (area under the receiver operating characteristic curve (AUROC): 0.91; 95% confidence interval (CI): 0.90-0.93). The FoCus study will aim to take a next step by relating in vivo assessed FAP protein-expression by [18F]-ALF-FAPI-74 positron emission tomography (PET) / computed tomography (CT) to CMS4 status in patients eligible for colorectal liver metastatectomy as a first proof of concept. Ultimately this will contribute to the development of a diagnostic tool for the comprehensive assessment of CMS4 load in patients with (metastatic) CRC by using [18F]-ALF-FAPI-74 PET/CT molecular imaging, to guide CMS4 subtype-directed therapy decisions.

NCT ID: NCT06149481 Recruiting - Clinical trials for Metastatic Colorectal Cancer

Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)

Start date: March 26, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Each year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs. This is called metastatic colorectal cancer (mCRC). Most people with mCRC survive only about 2 years. Objective: To test the ability of a combination of up to 4 experimental anti-cancer drugs treat mCRC. The names of these drugs are retifanlimab, TriAdeno vaccine, N-803, and SX-682. They are described below. Eligibility: Adults aged 18 years or older with mCRC. Participants must have Design: Participants will be screened. This includes having a physical exam, blood tests, urine tests, and imaging tests. If signed on to the study, participants will have 2 tumor biopsies. One when starting the study and once about 8 weeks after bring on the study. Participants will receive $500 for each biopsy. Participants will be treated with either 3 or 4 drugs and will receive a detailed calendar explaining when each drug is given. Retifanlimab is given every 4 weeks through an IV (an IV is tube attached to a needle inserted into a vein in the arm). N-803 is injected under the skin on the abdomen every 4 weeks. TriAdeno vaccine is injected under the skin of the upper arm or thigh once a month for 3 doses and then once every 3 months. Some participants will also receive a 4th drug. SX-682 is a pill taken by mouth. Participants will take this drug 2 times a day at home for about 3 weeks of each month. Study treatment will continue up to 2 years. Follow-up phone calls/emails may continue for 3 more years.

NCT ID: NCT06137170 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment

RegoSeq
Start date: March 1, 2024
Phase:
Study type: Observational

This is an observational study in which data already collected from people with metastatic colorectal cancer will be studied. Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus). Cancer is considered metastatic if it spreads to other parts of the body. The study drug, regorafenib, is already approved for doctors to prescribe to people with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. Other approved treatments for mCRC include TAS and bevacizumab. The combination of the anti-cancer drugs trifluridine and tipiracil is called TAS. Both TAS and bevacizumab prevent cancer cells from growing and multiplying. Some studies have shown that people with mCRC who took TAS along with bevacizumab, lived longer than when TAS was taken alone. This may be especially beneficial for patients who have tried other treatments before. However, there is limited knowledge about how and in which order these drugs are given. To better understand the impact of the order of taking regorafenib and TAS, with or without bevacizumab, more knowledge is needed about how well these treatments work in people with mCRC in European countries. The main purpose of this study is to learn more about the effects of treatment in people with mCRC who have already received regorafenib and TAS, with or without bevacizumab, one after the other (also called sequential treatment) in a different order. To do this, researchers will collect the following information: - how long participants received sequential treatment for mCRC - number of participants receiving further treatment for mCRC after the sequential treatment - number and type of further treatments for mCRC - how long did participants live (also called overall survival). The data will come from the participants' information stored in health records from 4 centers in 3 European countries including France, Italy, and Spain. The data will be from people with mCRC who started sequential treatment between January 2013 and December 2022 or until the most recent date that allows researchers to assess the participants' health for at least 3 months. In this study, only available data from routine care are collected. No visits or tests will be required as part of this study.

NCT ID: NCT06134388 Recruiting - Clinical trials for Metastatic Colorectal Cancer

Sulfasalazine in Patients With Metastatic Colorectal Cancer

Start date: September 1, 2023
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the potential efficacy and safety of sulfasalazine in patients with metastatic colorectal cancer.

NCT ID: NCT06118762 Recruiting - Clinical trials for Metastatic Colorectal Cancer

Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

Start date: October 20, 2023
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy

NCT ID: NCT06118047 Recruiting - Clinical trials for Metastatic Colorectal Cancer

Crisaborole Ointment for Skin Toxicity Induced by Cetuximab

COSTIC
Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective, single-arm, phase II clinical trial that will enroll metastatic colorectal cancer patients with Cetuximab-Related Skin Toxicity, who will receive crisaborole ointment twice daily.