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57 active trials for Colo-rectal Cancer

Collection of Gastrointestinal Malignant and Non-malignant Human Samples

To collect human tissue, blood, and fecal samples from patients suffering from Inflammatory Bowel Disease and Colorectal Cancer. The samples will be used to establish biomimetic human organ-on-a-chip technology, as well as study the role of the microbiome in the pathogenesis in human gastrointestinal diseases.

Start: July 2018

Stool Collection Sub-Study of Exact Sciences Protocol 2018-01

The primary objective of this sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer.

Start: July 2020

Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer

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).

Start: October 2020

A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

Start: December 2018

Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.

Start: November 2018

Optimizing Timing of Follow-up Colonoscopy

Overall Objective: To optimize timing of surveillance colonoscopy. Principal research question and specific aims: To assess the impact of access to a hand-held application on the timing of surveillance colonoscopy. To assess whether access to the tool improves adherence to recommended guidelines for follow-up colonoscopy intervals. Colonoscopy is commonly used for surveillance of patients with high risk of developing colorectal cancer, including those with family history of colorectal cancer and those with colorectal polyps. The recommended timing of surveillance colonoscopy varies by the estimated risk for development of colorectal cancer. The estimated risk varies by family history of colorectal cancer (number of affected individuals, age of the persons affected with CRC) and characteristics of the colorectal polyps (size, number, and histology of colorectal polyps (tubular or villous; high grade or low-grade dysplasia; sessile serrated polyp, sessile serrated polyp with dysplasia, hyperplastic polyp or traditional serrated adenomas). Guidelines take all of these factors into account in the recommendations for follow-up colonoscopy and hence are difficult to recall for the busy clinicians. Colonoscopy surveillance is frequently performed at shorter or longer than the recommended time intervals. The investigators have developed a smart phone application in which the characteristics of the patients can be inputted and the tool provides the recommended time interval for surveillance colonoscopy, based on North American guidelines. The investigators are proposing a pilot randomized trial to determine sample size estimates for a larger trial to assess the utility of this application in clinical practice.

Start: May 2021

Interactive Online Informational and Peer Support App for Patients With Low Anterior Resection Syndrome

After surgery for rectal cancer, many people undergo changes in bowel habits, which may include the need to empty their bowels more often, accidental leakage of stool or gas, the sudden urge to go to the bathroom, and more. The term "Low Anterior Resection Syndrome" or LARS is used to describe these symptoms. LARS has a negative impact on one's quality of life, and can lead to frustration, as there is no single intervention that has proven to be effective for LARS, and each patient has to undergo trial and error to find one's solution. As people struggle with LARS, they describe feeling hopeless and isolated. Peer support is a supportive relationship between individuals who share common experiences or face similar challenges. The goal of our study is to evaluate whether use of an online peer support application with trained mentors who themselves have lived or are living with LARS will empower patients to better manage their LARS symptoms and improve their quality of life.

Start: August 2020

Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or Lymphoma

This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a novel anti-cancer drug, GZ17-6.02 administered to patients with advanced solid tumors or lymphoma, which have progressed after receiving standard/approved therapy or where there is no approved therapy.

Start: March 2019

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors

Start: October 2017

Single-stapled Double Purse-string Technique for Colorectal Anastomosis

A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.

Start: March 2020

Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors

Tumor infiltration lymphocytes (TILs) have been harvested from advanced cancer patients and constructed to knockout PD1 gene and express scFvs against both PD1 and CTALA4 and CARs against various antigens, followed by transfusion into the patients. The safety, tolerance, and preliminary clinical efficacy of the TILs will be evaluated.

Start: January 2021

Peptide-based Immunization for Colon- and and Pancreas-carcinoma

An international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.

Start: April 2019

GOODBYE HARTMANN TRIAL: 100 YEARS OF HARTMANN'S PROCEDURE

Hartmann's procedure was described for the first time in 1921 as an alternative to abdominoperineal resection for the treatment of upper rectal tumours. Although Hartmann's procedure fell out of favour for rectal cancer after the introduction of restorative procedures, it remained the most common procedure in emergency setting for many years. Nowadays Hartmann's procedure is a useful procedure in selected cases e.g. severely ill patients with a high risk of anastomotic failure. However, restoring intestinal continuity for Hartmann patients is often associated with high morbidity, and about 70% will live with a permanent colostomy. Hartmann procedure' is a rapid and simple surgical technique intended to decrease perioperative morbidity and mortality. This technique is often performed by young surgeons Indeed, end colostomy may be necessary in situations where restoration of continuity is risky, either because of unfavorable local conditions or because a more definitive resection must be aborted due to hemodynamic instability. In the last decade the Hartmann's procedure has been revalued in many studies. In diverticular disease the results of DIVA arm of the LADIES trial showed that more patients in the primary anastomosis group were stoma free compared with patients in the Hartmann's procedure group. Other studies have observed no differences in major postoperative complications or postoperative mortality between patients undergoing primary anastomosis versus Hartmann's procedure. Hartmann's procedure reversals were associated with a higher risk of serious postoperative complications than were stoma reversals after primary anastomosis with ileostomy. Despite the growing evidence in favour of primary anastomosis and its inclusion as a valid treatment option for perforated diverticulitis or perforated sigmoid colon in recent clinical practice guidelines, some surgeons have been hesitant to undertake anastomosis in the setting of purulent or faecal contamination and continue to choose Hartmann's procedure to eliminate concerns about anastomotic leakage.

Start: March 2021

COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.

This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with nivolumab.

Start: September 2018

The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period

Main objective: To evaluate the bidirectional relationships between physical exercise and sleep parameters, as a part of multimodal prehabilitation intervention, on pre- and postoperative outcomes in surgical patients with colorectal cancer, in an RCT. Secondary objective: to determine whether the levels of anxiety and depression affect these relationships. Objectives are based on the overarching hypothesis that is sleep and physical activity influence each other through complex, reciprocal interactions including multiple physiological and psychological pathways. To achieve this, providing a multimodal prehabilitation, specifically physical exercise, involved in mental and physical health through different mechanisms, i.e., improving physical functioning and fitness, reducing side effects of cancer treatments, preventing bone loss and weight gain, improving the quality of life and sleep, decreasing symptoms of fatigue and depression. The present is a pilot study aiming to evaluate the bidirectional relationships between sleep and physical exercise, and the preliminary outcome has important implications for informing both clinical and public health practice. Research question: Does a multimodal intervention including physical exercise improve sleep quality and duration compared to standard of care, during the perioperative period? Conversely, does a better sleep quality and duration increases the level of physical exercise during the perioperative period? How the level of anxiety and depression will affect these relationships? If the Prehabilitation program specifically physical exercise will positively affect sleep quality and duration after surgery, in the way to be a protective factor of sleep to not be reduced by up to 55% compared to those receiving standard of care?

Start: September 2020

Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption

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.

Start: May 2019

Chemotherapy-induced Peripheral Neuropathy (CIPN) on Motor and Sensory Function

As cancer survival rates have been increased due to technological developments and early detection strategies, there has been been a growing need to assess the effect of long-term complications and adverse effects upon patients' functionality and quality of life. Chemotherapy, which is accepted to be the body of systemic adjuvant therapy is attributed to long-term survival, yet some side effects such as sarcopenia, loss of muscle strength and functional capacity, fatigue, and sensory disturbances due to the neurotoxic effects have been well known. Chemotherapy-induced peripheral neuropathy (CIPN) is a condition that is characterized by main loss of cutaneous sensation especially in the distal part of the extremities. CIPN affects approximately 30-40% of patients with cancer undergoing chemotherapy. Loss of sensation in distal sides of upper and lower extremities may cause not only deterioration of fine hand skills but also loss of balance and thereby one's mobility and independence are detrimentally affected. Thus, this study is aimed to assess CIPN in patients with cancer undergoing chemotherapy in a longitudinal design by assessing the cutaneous function of the sensory nerves and related effect of motor function.

Start: March 2021

The Influence of Type of Anesthesia on Postoperative Pain

The investigators designed a multi-center prospective randomized controlled trial to study the influence of the type of anesthesia on postoperative pain after laparoscopic colorectal cancer surgery. Half of the participants will be anesthetized with propofol and remifentanil, while the other half will be anesthetized with sevoflurane and remifentanil during the surgery. The investigators will measure opioid consumption and pain score in the acute postoperative phase.

Start: February 2020

Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal Cancer

Immunotherapy acquired resistance was observed in clinical practice. The investigators intended to add anlotinib to PD-1 inhibitors, hoping reverse the resistance.

Start: March 2021

Clinical Value of G-EYE Colonoscopy in Daily Practice for Adenoma Detection and Time for Polyp Removal

Colonoscopy parameters will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope

Start: March 2020