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600 active trials for Colorectal Cancer

A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors

This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.

Start: September 2019

Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening

This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program (which does not offer an explicit choice of screening modality). The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system that has a "FIT first" population health screening strategy. All patients will also have access to whatever CRC screening is recommended through usual visit-based care.

Start: September 2018

Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health

This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates.

Start: June 2020

Colorectal Cancer Awareness, Research, Education and Screening (CARES)

There are two parts to this study: (1) an information gathering phase leading to the development of new educational materials; and (2) a study to test the newly developed material. The information gathering phase has been completed. The purpose of this part of the research study is to test the usefulness and acceptability of new educational materials investigators have developed. Investigators will compare the new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.

Start: February 2011

Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)

The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings.

Start: April 2014

A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, the sensitivity of existing quantitative fecal immunochemical test (qFIT) is unsatisfying. A new technology qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin compared with existing commercially available qFIT, is developed and this study will prove the high diagnostic accuracy in detecting colorectal advanced adenoma.

Start: August 2020

Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)

Colorectal cancer (CRC) is a leading cause of cancer death in the United States. In North Carolina, as in many parts of the United States, CRC screening is substantially underused in vulnerable and marginalized populations. Uninsured, underinsured, and medically underserved populations rely on federally qualified health centers (FQHCs) for their healthcare and thus patients served by North Carolina's FQHCs are particularly likely to benefit from efforts and resources to improve CRC screening. The United States Preventive Services Task Force recommends several tests to screen for CRC, including annual screening with a fecal immunochemical test (FIT), for patients ages 50-75 years. Programs that include mailing FITs to patients have shown promise as an effective means of increasing CRC screening, including for vulnerable populations. This randomized controlled trial is designed to assess the effectiveness, feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to patients served by FQHCs. This study also assesses the effectiveness, feasibility, acceptability, and costs of delivering patient navigation from a central location to facilitate follow-up colonoscopy for patients with a positive (abnormal) FIT result. To assess adherence to the United States Preventive Services Task Force recommendations for annual screening with FIT, we will mail eligible participants one FIT per year for up to two years.

Start: July 2020

Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

Background: Many people with colorectal cancer get liver metastases. Standard treatment for this is a combination of chemotherapy drugs. Directing the chemotherapy to the liver may be effective. A device that does this a pump that delivers drugs over 2 weeks at constant rate into the hepatic artery. The person s body temperature causes the drug to flow from the pump. Researchers want to see if this helps people with colorectal metastases to the liver. Objective: To study the effectiveness of a hepatic artery infusion pump at treating colorectal metastases to the liver. Eligibility: Adults at least 18 years old with colorectal metastases to the liver Design: Participants will be screened with: Medical history Physical exam Heart, blood, and urine tests Scans Participants will stay in the hospital a few days. A small plastic tube (catheter) will be inserted in an artery into the liver. The catheter will be attached to the pump. That will lie under the skin on the abdomen. It will be small and participants will be able to feel it. Participants will get treatment in 28-day cycles. Every Day 1, they will have physical exam, symptom review, and blood tests. Every 2 weeks, they will come to the clinic to get chemotherapy by a catheter or port. Every 12 weeks, they will have a scan. Tissue samples may be taken during the study. When they finish the drug, participants may have the pump removed. They will repeat the Day 1 tests. They will be called every 6 months to see how they are doing. Sponsoring Institute: National Cancer Institute

Start: June 2019

Effectiveness of an Integrated Colorectal Cancer Screening in Saudi Arabia: A Pragmatic Randomized Trial

The global burden of colorectal cancer (CRC) incidence among young age groups is rising and overwhelming. This new trend of young-onset CRC incidence is evident in western countries. Unfortunately, Asian countries have shown the same epidemic shift in the past few years. As a consequence, this situation might necessitate revisiting the current screening program in this region. Saudi Arabia has a two-fold increase in CRC incidence among young age groups in the last 18 years (9.6/100000 for male versus 9.3/100000 for female). This rising incidence ascribed to the lack of a screening program and suggested lowering CRC screening to 40. The low awareness about risk factors, signs, and symptoms of the disease causes late presentation of CRC cases. Therefore, most presenting cases are associated with a poor prognosis and short survival. Educational and screening programs are, by no means, considered valuable and essential as CRC tends to affect younger age groups.

Start: June 2020

A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies

This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with mFOLFOX in participants with advanced metastatic gastroesophageal Cancer (GEC) or colorectal cancer (CRC).

Start: November 2018

The Combination of Immunotherapy and Stereotactic Ablative Radiotherapy in MSS Oligometastatic Colorectal Cancer

This is a prospective, single-center, single-arm phase II clinical trial. This study aims to evaluate the safety and tolerability of stereotactic ablative radiotherapy (SABR) in combination with Sintilimab, and to examine the impact of the combination therapy on tumor control, long-term survival and quality of life in patients with microsatellite stable (MSS) oligometastatic colorectal cancer. A total of 60 MSS oligometastatic colorectal cancer patients will be recruited and receive multisite SABR followed by immunotherapy of Sintilimab within one week from completion. Sintilimab will be given at a fixed dose of 200mg (100mg if weight < 50 kg) via intravenous infusion on the first day of each cycle, repeated every three weeks. The dosing will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal. The tumor regression, disease control, adverse events and long-term survival will be analyzed.

Start: March 2021

EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic C?lectomies Trial

The aim of the trial is to study the efficacy of continuous bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic colectomy.

Start: January 2021

Breakthrough Improvement Collaborative for ColoRectal Cancer (BIC4CRC)

Colorectal cancer is the most common cancer in Europe and the third worldwide. Approximately 1 in 20 men and 1 in 35 women will develop colorectal cancer at some moment in their life. In Flanders, in 2014, there was an increase in the detection of colorectal cancer with 21% compared to 2013. Early detection improves the prognosis for the patient. In this early stage, colorectal surgery is one of the most important treatments, but it is also complex and has a high complication rate. However, over the last decade, surgical care for patients with colorectal cancer has become more standardized. The use of structured care methods, such as care pathways and protocols, has helped in standardizing care processes. Specifically for patients with colorectal cancer, perioperative care has shifted with the implementation of Enhanced Recovery After Surgery (ERAS) programs. The goal of ERAS- protocols is to optimize the interventions during the perioperative hospitalization period and reduce postoperative complications. Despite the increasing evidence in favor of the use of these standardized protocols, adherence and implementation in daily practice remains challenging. The primary goal of this quality improvement project is to enhance the standardization of key interventions in the ERAS care process for patients undergoing colorectal surgery. Therefore, adherence to the ERAS-guidelines will be investigated and hospitals will receive feedback to set up improvement initiatives. Moreover, interactive group sessions and on-site training activities will stimulate knowledge sharing and define best practices.

Start: March 2018

Cognitive Behavior Therapy (CBT) and Psychological Status and Immune Function

To explore the effect of CBT on psychological status of patient undergoing colorectal cancer surgery and primary caregivers. To explore the effect of CBT on immune function of patient undergoing colorectal cancer surgery and primary caregivers.

Start: March 2021

Diffusion-Weighted MRI for Liver Metastasis

The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM).

Start: November 2016

Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

This phase I/II studies the side effects and best dose of regorafenib when given together with pembrolizumab in treating participants with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as regorafenib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and pembrolizumab may work better at treating colorectal cancer.

Start: June 2019

Synergism of Immunomodulation and Tumor Ablation

This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable or in partial remission after completion of 4-6 months first line systemic therapy. The primary objective of the study is to show an overall response rate of lesions not treated by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria) higher than 10%. With the continuation of first line systemic treatment, no further responses are expected. Secondary objectives are: To establish the feasibility and safety of the combined treatment modalities; To study the impact of the local technique (RFA/Radiotherapy) on the results; To investigate biomarkers to predict response to the combined treatment

Start: November 2018

A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population

To compare the performance of stool-based SDC2 DNA methylation test and commercially available Fecal Immunochemical Test (FIT) for detection of advanced colorectal neoplasia and other precancerous lesions in the asymptomatic Chinese community population. The potential uses of a risk-scoring system (APCS) would be evaluated too.

Start: March 2021

Evaluating the Cologuard Test for Use in Lynch Syndrome

This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit.

Start: June 2021

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

This study is a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These two treatment arms will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

Start: July 2019