Colon cancer clinical trials — recruiting now

The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: * Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program

Colorectal cancer is one of the most common malignant tumors, accounting for approximately 10% of new cancer cases and cancer-related deaths worldwide each year. In recent years, with the development of industrialization and urbanization, the increase in the number of elderly patients, and changes in dietary structure and lifestyle habits, the incidence and mortality rates of colorectal cancer in China have risen significantly. Some patients are already in locally advanced or late stages at the time of diagnosis, making treatment more difficult. Among them, patients with MSI-H/dMMR colorectal cancer account for about 10% to 15% of the total. Neoadjuvant therapy for rectal cancer primarily targets resectable mid-to-low rectal cancer patients with T3/4 and any N stage. Currently, neoadjuvant therapy for rectal cancer mainly involves chemoradiotherapy, while patients with a low risk of recurrence may opt for neoadjuvant chemotherapy. For patients with mid-to-low locally advanced rectal cancer, intensified systemic chemotherapy can be chosen before and after preoperative radiotherapy. For patients with technical difficulties in sphincter preservation but a strong desire to preserve the sphincter, higher intensity treatments can be considered, such as the CinClare protocol of concurrent chemoradiotherapy with capecitabine and irinotecan, the FOWARC protocol of concurrent radiotherapy with FOLFOX, or interval chemotherapy, including total neoadjuvant therapy. However, for MSI-H/dMMR patients, neoadjuvant chemoradiotherapy is less effective. Xu Ruihua from the Sun Yat-sen University Cancer Center evaluated the clinical response and safety of four cycles of neoadjuvant treatment with sintilimab in dMMR or MSI-H colorectal cancer. In this study, 16 patients underwent at least one response evaluation. All six patients who underwent radical surgery achieved R0 resection. Tumor shrinkage was observed in 15 patients (94%) at the first evaluation after treatment. Among the 16 evaluable patients, 3 (19%) underwent radical surgery and achieved pCR, 9 (56%) achieved cCR and opted for a watch-and-wait strategy, 3 (19%) did not achieve cCR and underwent radical surgery with residual tumor found in the pathological specimens. One patient (6%) discontinued treatment due to a severe adverse event (grade 3 encephalitis), did not achieve cCR, and refused surgery. The results of immunotherapy in patients with MSI-H/dMMR metastatic colorectal cancer have greatly encouraged researchers to explore its application in neoadjuvant therapy. The NICHE study, the world's first neoadjuvant immunotherapy study in non-metastatic colon cancer, showed a 100% MPR and a 69% pCR rate after neoadjuvant immunotherapy in 32 patients with dMMR colon cancer. Based on this study, the larger NICHE-2 study was conducted, enrolling a total of 112 patients with non-metastatic dMMR colon cancer. These patients received one dose of ipilimumab (1 mg/kg) combined with nivolumab (3 mg/kg) followed by one dose of nivolumab (3 mg/kg) monotherapy within 6 weeks before surgery. The short-term efficacy results showed an MPR of 95% and a pCR rate of 67%, consistent with previous results, with good tolerability and only 4% experiencing grade 3-4 adverse events. Sintilimab targets the same molecule as nivolumab and pembrolizumab but has a different amino acid sequence. Multiple preclinical in vitro studies have validated the effect of sintilimab in blocking the PD-1 pathway. Completed preclinical pharmacodynamics, animal pharmacokinetics, and toxicology studies have shown that sintilimab has clear targets, reliable cell line sources, good drug stability, and has demonstrated good activity in completed preclinical studies. Based on multiple previous studies, the optimal cycle for neoadjuvant immunotherapy has not yet been determined. However, different treatment cycles result in significant differences in pCR, which may be related to the number of treatment cycles. This study aims to explore the postoperative pathological complete response rate of 8 cycles versus 4 cycles of neoadjuvant sintilimab treatment in dMMR/MSI-H locally advanced colon cancer.

Neoadjuvant immunotherapy has shown promising therapeutic effects in mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) colorectal cancer (CRC). However, for patients with mismatch repair-proficient or microsatellite stable (pMMR/MSS) CRC, the efficacy of PD-1 monoclonal antibody remains limited. Enhancing the efficacy of immunotherapy in pMMR/MSS CRC has become a key area of exploration. Additionally, for locally advanced (cT4NxM0) CRC patients, achieving R0 resection poses a significant challenge. Failure to achieve R0 resection often results in recurrence, severely impacting patient survival outcomes. Our previous phase II clinical study (BASKET Ⅱ) demonstrated that the neoadjuvant regimen of mFOLFOX6 combined with Bevacizumab and PD-1 monoclonal antibody significantly enhanced the immunotherapy sensitivity of locally advanced pMMR/MSS CRC, leading to improved pathological complete response (pCR) rates and higher R0 resection rates. This prospective, multicenter, randomized phase III trial aims to evaluate whether the neoadjuvant regimen of mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody can further improve pCR rate, enhance survival outcomes, and maintain an acceptable safety profile compared to mFOLFOX6 alone in pMMR/MSS locally advanced CRC patients.

This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer

The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection. The names of the groups in this research study are: * Group A: Prehabilitation program * Group B: Usual Care

To learn if cemiplimab can help to control dMMR colon cancer.

INTRODUCTION Colorectal cancer rates are rising, with surgery emphasizing radical resection and vessel ligation. Conventional methods using clips pose risks of bleeding and complications. Ultrasonic scalpels offer a safer alternative, approved for various surgeries, but their efficacy in colorectal cancer surgery needs prospective validation. STUDY OBJECTIVE Study compares safety/efficacy of clipless vs. clip-type hemostasis using ultrasonic scalpel in colorectal surgery, focusing on post-op bleeding frequency, intraoperative bleed, drainage, hospital stay. STUDY DESIGN This study is a prospective, randomized, single-center study comparing clipless ultrasonic energy-based hemostasis versus conventional clipping hemostasis in performing laparoscopic colectomy. The study's experimental group undergoes surgery with an ultrasonic scalpel, while the control group receives treatment with a monopolar energy device and clips. Allocation to groups, using a 1:1 ratio, is randomized via a computerized table by a blinded coordinator, immediately post-anesthesia. Principal investigators and administrators remain blinded throughout the study. STUDY POPULATION 1\. Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with colonic adenocarcinoma and are subject to a colectomy procedure. All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site. RISK ANALYSIS The surgical procedure, postoperative care, and follow-up will be the same for the experitmental and control groups in this study. The use of the ultrasonic scalpel alone may prevent complications such as clip-induced intestinal obstruction, infection, bleeding from clip dislodgement, bile leakage, and infection, but there is no additional benefit for other subjects. The risk of bleeding when ligating vessels with an ultrasonic scalpel has been demonstrated to be safe in retrospective studies for vessels 7 mm or less (8-17). Vessels larger than 7 mm are ligated using surgical clips because the safety of ligation with the ultrasound scalpel has not been studied. Based on the reported safety of this method of ligation, the risks do not outweigh the benefits when analyzed in the aggregate. QUALIFICATION OF PARTICIPATING SURGEONS 1. Surgical procedure * Laparoscopic surgery: Surgery for colorectal cancer consists of ligating blood vessels to the lesion, detaching or mobilizing the colon, and resecting and anastomosing the bowel. * Clipless ultrasound energy-based hemostasis arm: the ultrasound scalpel is used to dissect and ligate the vessel, but clips are used for vessels larger than 7 mm in diameter. If there is significant bleeding during the procedure, surgical clips and hemostatic agents may be used for patient safety at the discretion of the surgeon. * Control arm: a combination of monopolar cautery and surgical clips will be used for vascular ligation and lymph node dissection. 2. Procedure standardization and qualification procedure This study is about laparoscopic surgery for colorectal cancer and all surgeries will be performed by surgeons with at least 100 laparoscopic colorectal cancer surgeries. STATISTICAL ANALYSIS This study compares the frequency of postoperative bleeding between clipless and clip-type ultrasound energy hemostasis in laparoscopic colorectal cancer surgery, assuming that there will be deviations from randomization, such as switching of surgical groups after randomization or additional vessel ligation with clips during or after surgery, we will perform a per-protocol analysis. The missing values of postoperative bleeding, intraoperative blood loss, intraoperative blood transfusion, and conversion to laparotomy are assumed to be none, and the missing values of postoperative drainage tube hematocrit and drainage tube triglycerides are converted to the mean values of the same group. Outliers will be retained without replacement for intraoperative blood loss, operative time, maximum postoperative plasma hemoglobin decline, and total drainage volume within 5 days postoperatively. For Type 1 errors, the frequency of postoperative intra-abdominal bleeding in the control group will be analyzed during data safety monitoring every 50 cases to ensure that it is less than 0.5-4.5% according to the literature.

This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.

The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.

The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic/locally advanced unresectable colorectal cancer

This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.

Multidisciplinary teams (MDTs) represent the gold standard for personalized tumor treatment, but they are limited by medical resources and accessibility Limitation. Although large language models (LLMs) have shown promise in medical reasoning, their multidisciplinary practicality in pan-cancer MDTs has not been fully explored. In the early stage of this project, LLMs with high clinical application efficacy were identified through benchmark tests, and an open-label randomized controlled study (RCT) was conducted based on these LLMs. The research aims to explore whether AI-assisted assistance can enhance the accuracy and writing efficiency of MDT diagnosis and treatment reports. This study intends to prospectively collect the diagnosis and treatment information of 20 patients and MDT diagnosis and treatment information. It is planned to recruit 40 junior doctors. Doctors in the intervention group will use LLM to assist in the writing of MDT reports, while doctors in the control group will use traditional information retrieval methods for the writing of MDT reports. Three clinical experts ultimately used a standardized Likert scale to conduct comprehensive and multidisciplinary scoring of the MDT reports of the intervention group and the control group. This study quantitatively compared the diagnosis and treatment quality and efficiency of the MDT AI-assisted model and the traditional model to verify the application potential of large language models in assisting tumor diagnosis and treatment.

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.

This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). At the University Health Network, this IVLP technique has been used recently in a Phase I study in patients with sarcoma, and we are now expanding on that experience to include patients with colorectal metastases. The purpose of this study is to test the safety of the IVLP technique and find the dose that seems right in humans. Participants are given oxaliplatin into one lung via IVLP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more participants are asked to join the study and are given a higher dose of oxaliplatin. Participants joining the study later on will get higher doses of oxaliplatin than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The other lung will not be infused with anything, so that we can limit unforeseen toxicity to a single lung and see if one lung does better than the other.

This phase I/II trial studies the side effects of pulmonary suffusion in controlling minimal residual disease in patients with sarcoma or colorectal carcinoma that has spread to the lungs. Pulmonary suffusion is a minimally invasive delivery of chemotherapeutic agents like cisplatin to lung tissues. Drugs used in chemotherapy, such as cisplatin, 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. Pulmonary suffusion may also be useful in avoiding later use of drugs by vein that demonstrate no effect on tumors when delivered locally.

This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. To address this gap and improve CRC screening rates, investigators aims to recruit a total of 1,200 African American participants aged 45-75 during their visits to the DMV, 4606 N 56th St Ste100, Omaha, for CRC screening. All participants will receive a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages and calls, and post-FIT navigation support for participants with positive results or without family doctor/insurance. Kits are returned to a designated Nebraska Medicine lab for testing, and test results will be mailed to participants within 14-21 days. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution group with social media advertising group. The social media advertising group will additionally be exposed to targeted ads on platforms like Facebook, Instagram, and YouTube to increase awareness and potentially improve participation rates. The study will compare FIT kit return rates, positive screening rates, and completion rates of follow-up colonoscopies after positive FIT results between the two groups.

This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.

This clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved together as standard of care treatment for adult patients with breast cancer (often with other anti-cancer drugs). This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Trastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.