Active clinical trials for "Rectal Neoplasms"

Immunoscore has been reported to be superior to microsatellite instability staging in predicting the disease-specific recurrence and survival for patients with colorectal cancer. However, the relationship between Immunoscore and its impact on patient's response to PD-1 blockade remains to be elucidated. This phase II, prospective, open label study is designed to evaluate the efficacy and safety of combination neoadjuvant chemoradiotherapy (nCRT) with the anti-PD-1 antibody sintilimab for intermediate/high Immunoscore locally advanced rectal cancer.

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.

Urinary and sexual dysfunctions are among the most common complications in rectal cancer surgery. The aim of this study was to investigate the protective effect of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. This is a prospective, single-arm, multicenter, uncontrolled, clinical study in 88 eligible subjects with mid-low rectal cancer. After informed consent, eligible patients will be performed laparoscopic FTME surgery. Patients' demographic, operative detail, postoperative outcomes and follow-up will be recorded prospectively.

The ACO/ARO/AIO-21 investigator-driven, open-labeled, phase I drug re-purposing trial will assess whether the IL-1 receptor antagonist Anakinra can be safely combined with fluoropyrimidine-based chemoradiotherapy (CRT) in patients with rectal cancer.

This study is designed to explore the hypothesis that in patients with a Locally advanced rectal cancer (LARC) treated with a Total neoadjuvant therapy (TNT) strategy based on short course radiotherapy (5x5Gy) followed by neoadjuvant consolidation chemotherapy is associated with a higher rate of pathological clinical response and sustained (>1year) complete clinical response when compared to an historical cohort treated with long course chemoradiation therapy (CRT), total mesorectal excision (TME) and adjuvant chemotherapy (ACT).

This clinical trial is designed to determine the maximum tolerated dose of niraparib when combined with dostarlimab and hypofractionated radiation for locally advanced rectal cancer. Once this is determined, this dose will be tested to identify what impact it has on the tumor as well as patient reported outcome measures.

Colorectal cancer (CRC) is the third most common cancer (1.8 million cases) and the third most common cause of cancer-related death (0.8 million deaths) worldwide in 2018, and rectal cancer accounts for roughly one-third of CRC. The main curative treatment modality for patients with rectal cancer is surgery, often combined with chemotherapy and/or radiotherapy (RT). The global recognition of total mesorectal excision (TME), that decreased locoregional recurrence (LRR) by itself, questioned the need for radiotherapy (RT) before or after surgery. Several randomized trials have demonstrated the importance of preoperative RT (short course RT or long course chemo-radiotherapy (CRT)) in reducing LRR, in patients with high-risk rectal cancer. However, RT or CRT does not improve overall survival, and in addition neoadjuvant RT/CRT followed by TME is associated with perioperative morbidity and the risk is increasing with age. Therefore, ongoing trials are testing other strategies, such as the omission of (C)RT or even avoidance of surgery. In May 2022, a presentation with simultaneous NEJM publication showed that 14/14 patients with dMMR rectal cancer obtained complete response after six months (9 cycles every 3 weeks) of immunotherapy (dostarlimab). Thus, the investigators have now become confident that immunotherapy without surgery will be the "new standard", and the investigators will recommend a W&W strategy in patients with rectal cancer obtaining major tumor shrinkage and these patients will be followed carefully with clinical and molecular evaluation (which was not part of the NEJM paper). No patient in the NEJM paper had progressive disease and therefore the investigators recommend a second cycle of immunotherapy (instead of resection in unclear cases) and re-evaluation. The investigators are confident that 1 or 2 cycles of immunotherapy will result in complete radiological, pathological, and molecular response in a substantial number of patients and this short duration of therapy will reduce toxicity and especially drug costs. In conclusion, immunotherapy in patients with dMMR CRC tumors may completely eradicate the primary cancer and regional lymph nodes leading to a possibility for organ-sparing medical treatments, and the investigators are confident that this new strategy of 1 or 2 cycles of immunotherapy will be the future standard of care, and in Denmark the investigators have the chance to monitor these patients closely with clinical and high-level molecular follow-up.

Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging

The purpose of this study is to explore whether rectal artery infusion chemotherapy combined with anti-PD1 antibody is an effective neoadjuvant therapy for the microsatellite stable locally advanced rectal cancer.

Open to patients undergoing any pre-operative treatment for locally advanced rectal cancer, TRIGGER is the only phase III clinical trial in the UK offering watch and wait. All patients will have post treatment MRI scans routinely performed, no change from the MERCURY trials high resolution MRI protocol is required. Patients will be randomised to either the control arm for management according to national guidelines - conventional MDT, clinical assessment post-treatment planning using the baseline MRI. Patients in the interventional arm will have their post treatment MRI scans read by a radiologist trained and supported to reliably report the mrTRG grade and have their management directed accordingly - 'Good response' (mrTRG 1&2) - watch and wait (avoidance of surgery) offered. 'Poor response' (mrTRG 3-5) - local colorectal MDT is informed and uses information to discuss and agree next steps in treatment and surveillance. Patients are followed up for five years with QoL questionnaires completed at registration, 3 and 5 years.