Active clinical trials for "Rectal Neoplasms"

This study is a prospective, randomized, open, controlled, multi-center phase II clinical trial, which included patients with locally advanced low rectal cancer as the research object, and evaluated the application of long-term concurrent chemoradiotherapy combined with tislelizumab versus long-term synchronous Efficacy and safety of chemotherapy and radiotherapy as neoadjuvant therapy for patients with locally advanced rectal cancer. The main endpoints of the study were clinical complete response (cCR) (including imaging and endoscopic complete response) and pathological complete response (pathological complete response, pCR). Secondary study endpoints are primary pathological response rate (MPR), objective response rate (ORR), disease-free survival (DFS), overall survival (OS), organ preservation rate (OPR), rectal cancer neoadjuvant therapy score (NAR ), quality of life score (QoL), safety and tolerability. They will be randomly divided into an experimental group (tislelizumab combined with long-term concurrent chemoradiotherapy) and a control group (long-term concurrent chemoradiotherapy) at a ratio of 2:1. Random stratification factors: 1. TNM stage (II/III); 2. Distance from the tumor to the anal verge (≥5cm, <5cm).

The goal of this clinical trial is to test the efficacy and safety in patients with locally advanced middle and lower rectal cancer. The main questions it aims to answer are:• Whether Cadonilimab combined with chemotherapy following short-course radiation can improve pathological complete response(pCR) rate? •Are the toxicities of the combination therapy manageable? Participants will be given radiation of 5 Gy for 5 days and then neoadjuvant Cadonilimab combined with modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) for 6 cycles. Without progressed disease, total mesorectal excision (TME) or transanal local excision will be performed. If clinical complete response was received, watch and wait strategy is one of choices. Adjuvant Cadonilimab plus mFOLFOX6 for another 6 cycles could be suggested for non-pCR participants,while surveillance is also suitable for pCR ones.

This study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer.

Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment). This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.

In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservation with dose-escalation, but it is unclear whether this was primarily due to tumor stage or dose level. The aim of the present study is to investigate if a higher dose of radiotherapy is superior compared to a standard dose in patients with early rectal cancer undergoing chemoradiotherapy with curative intent.

The addition of durvalumab to total neoadjuvant therapy (TNT) in locally advanced rectal cancer may improve the pathological complete response rate. The induction platinum-based chemotherapy may increase the neoantigen formation together with the chemoradiotherapy period. Starting durvalumab during the first chemotherapy session and continuing during the 6-week period of chemoradiotherapy could change and create the needed environment to increase the efficacy of durvalumab in this setting. Additionally, the 8-12 week rest period from the end of the chemoradiotherapy and the radical surgery, treatment with durvalumab may continue improving the response and outcome of patients without jeopardizing the surgery (which needs this period out of chemotherapy and radiotherapy to avoid postoperative complications, but not for anti-PDL-1 therapy). Patients will be included following inclusion/exclusion criteria in a prospective, non-randomized, open label, single arm phase II study to receive 6 cycles of mFOLFOX6 (oxaliplatin, leucovorin and fluorouracil) followed by long course chemoradiotherapy (50.4 Gy together with capecitabine) followed by surgery. Patients will receive durvalumab 1500 mg every 4 weeks during induction chemotherapy, chemoradiotherapy and waiting period until surgery.

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response. The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders. "Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).

This early phase I trial investigates how well 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy and radiotherapy. Using 64Cu-labeled M5A positron emission tomography imaging may play a significant role in imaging patients with colorectal cancer.

Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.