Rectal Cancer

In Austria, patients with rectal cancer that has not spread to other parts of the body are typically treated with either total neoadjuvant therapy (TNT) or immunotherapy, depending on their microsatellite status (DNA repair capacity). However, treatment can vary considerably between hospitals in Austria. These differences may include the type and duration of treatment, as well as the active ingredients used. There are currently no clear recommendations on which exact treatment is best for each specific case. The aim of this observational study is to collect information on the different treatments used in Austria for patients with localized rectal cancer and to document the outcomes of these treatments. Only information and samples collected as part of the patients' routine care will be used for the study. Participation in the study will not change or affect the treatment chosen by the treating physician.

In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.

This study is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status. The aim is to investigate the safety and efficacy of neoadjuvant chemoradiotherapy combined with sintilimab and suvecitib. Patients will receive long-course chemoradiotherapy (concurrent capecitabine, 1000 mg/m², twice daily, days 1-14, Q3W, 2 cycles; sintilimab, 200 mg, d1, IV drip, Q3W, 2 cycles), followed by 6 cycles of the Capeox regimen in combination with sintilimab and suvecitib, namely oxaliplatin 130 mg/m², d1, IV infusion, every 3 weeks; and capecitabine 1,000 mg/m², twice daily, days 1-14, every 3 weeks; sintilimab, 200 mg, Day 1, IV drip, every 3 weeks; suvectitumab (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, IV drip, every 3 weeks. A total of 8 cycles of sintilimab and 6 cycles of suvectitumab were administered during the neoadjuvant treatment period. If, following completion of neoadjuvant therapy, the subject has not achieved cCR/near-cCR status, TME surgery or other therapeutic surgery shall be performed; the interval between the final dose of suvectitumab and surgery should be ≥6 weeks. If cCR/near-cCR status is achieved, watchful waiting or other treatment options shall be discussed with the patient. The adjuvant treatment regimen following surgery shall be determined by the investigator based on the patient's pathological results.

Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.

Background: A new cancer therapy involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. This therapy is called gene transfer using anti-KRAS G12V mTCR cells. Objective: To see if anti-KRAS G12 V mTCR cells are safe and can shrink tumors. Eligibility: Adults at least 18 years old with cancer that has the KRAS G12V molecule on the surface of tumors. Design: In another protocol, participants will: Be screened Have cells harvested and grown Have leukapheresis In this protocol, participants will have the procedures below. Participants will be admitted to the hospital. Over 5 days, participants will get 2 chemotherapy medicines as an infusion via catheter in the upper chest. A few days later, participants will get the anti-KRAS G12V mTCR cells via catheter. For up to 3 days, participants will get a drug to make the cells active. A day after getting the cells, participants will get a drug to increase their white blood cell count. This will be a shot or injection under the skin. Participants will recover in the hospital for 1-2 weeks. They will have lab and blood tests. Participants will take an antibiotic for at least 6 months. Participants will have visits every few months for 2 years, and then as determined by their doctor. Visits will be 1-2 days. They will include lab tests, imaging studies, and physical exam. Some visits may include leukapheresis or blood drawn. Participants will have blood collected over several years. ...

Surgical treatment of cancer of the lower rectum by resection and coloanal anastomosis or abdominoperineal resection in both cases exposes the patient to significant functional digestive sequelae (anal incontinence or permanent stoma), and also to urinary and sexual consequences, which have a major impact on quality of life. Locally advanced rectal cancers leading to one or the other of these two procedures have practically the same characteristics: always fairly large cancers, located in the distal third of the rectum, in most cases requiring neoadjuvant chemoradiotherapy and a temporary or permanent stoma. Recent surgical advances and improved adjuvant therapy are increasingly steering patients toward "at all costs" sphincter preservation, sometimes at the expense of quality of life. Abdominoperineal resection with permanent ostomy is classically believed to have a detrimental effect on quality of life compared with resection and low anastomosis. Very few studies have compared these two procedures in terms of long-term functional results and quality of life. Most of them are small and/or retrospective case series, involve heterogeneous populations, or use questionable methodology. As randomized patients between sacrifice or preservation of the anus, seem not ethical, the study propose to compare in a prospective single-center study two very close populations of patients presenting advanced cancer of the lower rectum after chemoradiotherapy, treated by abdominoperineal resection or resection and coloanal anastomosis, with the objective to determine long-term quality of life. Most studies, including the recent prospective one, showed no substantial difference between the two procedures in terms of quality of life or functional difficulties. With the caveat of the biases, sphincter conservation would nevertheless seem that is associated with a better quality of life.The aim of this single-centre retrospective study is to compare the quality of life over more than three years in a population of patients with locally advanced lower rectal cancer who underwent surgery after chemoradiotherapy, either rectal resection and coloanal anastomosis or abdominoperineal amputation. This study might conclude that one procedure is superior to the other in terms of quality of life and help to choose the best technique, which could lead to substantial changes in the management of advanced cancers of the lower rectum.

This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans.

The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).

To investigate a potential toxicity benefit of preoperative radiation therapy with protons compared to conventional photon beam radiation therapy in patients with locally advanced rectal cancer.

Primary Objectives： Evaluate the complete response rate (CR rate) and safety of short - course radiotherapy combined with ivonesimab (AK112) in patients with pMMR/MSS mid - low rectal cancer. Secondary Objectives： Evaluate treatment - related toxic reactions, the quality of life, long - term prognosis (local control \[LC\], disease - free survival \[DFS\] and overall survival \[OS\]). Patients will : Receive Radiotherapy: Pelvic IMRT or VMAT, DT 25Gy/5Fx. One week after radiotherapy, begin treatment with Ivorsimab (AK112) at a dose of 20mg/kg by intravenous drip on day 1. One cycle is 21 days, and a total of 6 cycles are to be carried out. Evaluate the curative effect after 3 cycles of treatment. Patients with progressive disease (PD) will withdraw from the study, and other treatment plans will be adjusted in a timely manner. Patients with CR/PR/SD will continue treatment for another 3 cycles. Conduct a comprehensive assessment after 6 cycles of treatment. Patients who achieve cCR can choose the watch - and - wait approach. For patients who do not achieve cCR, TME surgery is recommended. Decide whether to perform adjuvant chemotherapy based on the postoperative pathological findings.

This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.

This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.

The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.

The purpose of this study is to evaluate the safety and clinical activity of combining DCSZ11 with radiation and capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with mismatch repair proficient (pMMR) high risk locally advanced rectal cancer.

Enrolled patients will receive upfront (week 1) short-course radiotherapy to gross pelvic disease (25Gy in 5fx) in combination with AB928 (150 mg orally, once daily as part of a continuous dose regimen). This will be followed by consolidation chemotherapy (weeks 3-20) with mFOLFOX x9 cycles in combination with AB928 and AB122.

A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer

Low Anterior Resection Syndrome (LARS) is a common complication after sphincter-preserving rectal cancer surgery and may negatively affect bowel function and quality of life. Although exercise has been shown to improve physical function and well-being in cancer survivors, evidence regarding its effects on LARS symptoms remains limited. This randomized controlled, multicenter study aims to evaluate the effects of an aerobic exercise program combined with guided imagery on bowel symptoms, quality of life, physical activity level, functional capacity, and psychological well-being in patients with LARS after rectal cancer surgery. Participants will be randomly assigned to either an intervention group receiving aerobic exercise and guided imagery in addition to standard care or a control group receiving standard care alone. Outcomes will be assessed at baseline and after the intervention period using validated clinical and patient-reported outcome measures. The findings of this study may contribute to the development of evidence-based rehabilitation strategies for improving bowel function and quality of life in patients with LARS following rectal cancer surgery.

The goal of this clinical trial is to evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as pMMR type locally advanced mid-lower rectal adenocarcinoma (tumor lower margin ≤ 10 cm from the anal verge); 3.With the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to preserve anal function during surgery; 4. No distant metastasis observed in routine chest and abdominal CT scans.

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.

The purpose of this prospective, observational, multicenter study is to evaluate the impact of adjuvant radiotherapy or chemoradiotherapy on disease-free survival (DFS) in patients with pathological T1 (pT1) rectal cancer presenting with at least one high-risk histological factor, such as deep submucosal invasion, poor differentiation, tumor budding, lymphovascular invasion, or positive resection margins, after local surgical or endoscopic excision, including Endoscopic Submucosal Dissection (ESD), Transanal Minimally Invasive Surgery (TAMIS), or Transanal Endoscopic Microsurgery (TEM). The study focuses on a specific patient population that has refused standard radical surgery with Total Mesorectal Excision (TME) because of its potential impact on quality of life and postoperative morbidity. The primary objective is to assess whether organ-preserving local treatment strategies can provide an effective alternative by evaluating long-term oncologic outcomes, quality of life, and colostomy-free survival.

A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.

This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy. This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.

This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.

The iCaRe2 is a multi-institutional resource created and maintained by the Fred \& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.