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Rectal Neoplasms clinical trials

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NCT ID: NCT06311279 Recruiting - Rectum Cancer Clinical Trials

End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum

Start date: March 5, 2024
Phase: N/A
Study type: Interventional

Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality.

NCT ID: NCT06300489 Recruiting - Rectal Cancer Clinical Trials

Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

Start date: March 3, 2024
Phase: Phase 1
Study type: Interventional

This study is a multicenter, open, and phase I dose increasing clinical study. Based on the UGT1A1 * 28 and * 6 genotypes of patients with locally advanced rectal cancer, determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase II clinical study,and explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the same time,Preliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy.

NCT ID: NCT06286956 Recruiting - Rectal Polyp Clinical Trials

Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device

UNI-VEC
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial).

NCT ID: NCT06266832 Recruiting - Clinical trials for Rectal Adenocarcinoma

The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma.

NCT ID: NCT06254521 Recruiting - Rectal Cancer Clinical Trials

The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer

Start date: February 22, 2024
Phase: Phase 2
Study type: Interventional

This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced MSS rectal cancer.

NCT ID: NCT06249672 Recruiting - Rectal Cancer Clinical Trials

Longterm Functional Outcomes in Patients Undergoing Organ Preserving Treatment for Rectal Cancer With or Without Local Excision After Chemoradiotherapy

PRESERVE
Start date: January 17, 2023
Phase:
Study type: Observational

Treatment of rectal cancer by standard neoadjuvant chemoradiotherapy protocols leads to a complete response in about 15% of patients, or even a higher fraction if radiotherapy is followed by an Oxaliplatin based chemotherapy as published recently. If patient presents with a (near) complete response at the time of restaging after neoadjuvant treatment, an organ preservation strategy can be an alternative treatment to low anterior resection or abdominoperineal excision of the rectum. An organ preserving strategy is an ideal option for patients that are too frail for a major oncological resection. Furthermore, organ preservation is increasingly an option for a broader spectrum of patients as there is growing evidence that it allows to avoid surgical risks, including major dysfunction of the urinary, sexual and anorectal function at equivalent oncological outcomes. Studies investigating organ preserving rectal cancer treatment can broadly be divided into two categories. The first option is a planned local resection of the remaining scar at the site of the tumor after chemoradiotherapy. This can be achieved by direct transanal resection in very low tumors or by an endoscopic procedure as TEM (transanal endoscopic microsurgery) or TAMIS (trans-anal minimally invasive surgery). The advantage of this approach is the resulting pathological diagnosis which can confirm the complete response microscopically or indicate if there is remnant tumor tissue left and whether this is completely removed. However, local resection might have an additional negative functional impact and cumulate with function impairment from chemoradiotherapy. Alternatively, patients after complete clinical response can directly enter a surveillance programme without excision of the remaining scar after neoadjuvant treatment. This strategy provides less certainty about the complete regression of the primary tumor, but allows a treatment completely without surgical interventions and might lead to an even better functional outcome compared to patients undergoing local excision. There is good evidence that the influence of chemoradiotherapy on anorectal and genitourinary function is relevant. However there is lack of good quality data how much local excision adds to this impairment on the long run. In this study the investigator aims to compare functional outcomes and subjective treatment satisfaction in patients undergoing organ preserving treatment for rectal cancer with and without local resection after chemoradiotherapy. This data will help patients and healthcare personal to choose between these treatment options in the future, knowing the difference in functional outcome between the groups. As this is an observational study, there will not be any influence on treatment decisions for the included subjects. Clinical data will be collected by questionnaires and compared between the two cohorts, which is in line with a risk category A according to HRO (Human Research Ordinance).

NCT ID: NCT06246344 Recruiting - Rectal Cancer Clinical Trials

MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer

Start date: December 1, 2023
Phase:
Study type: Observational

Colorectal cancer has an annual incidence surpassing 700,000 cases globally, ranking as the fourth most prevalent cancer with the second-highest mortality rate. Rectal cancer accounts for approximately one-third of newly diagnosed colorectal cancer cases. Stages II (cT3-4/N0) and III (cT1-4/N1-3) rectal cancer are commonly classified as Locally Advanced Rectal Cancer (LARC), characterized by a high risk of local recurrence post-surgery. Neoadjuvant chemoradiotherapy (CRT) combined with Total Mesorectal Excision Surgery (TME) has reduced the 5-year local recurrence rate in LARC from 25% to 5%-10%. Currently, neoadjuvant CRT+TME+postoperative adjuvant chemotherapy effectively controls local recurrence in LARC. However, it is associated with low Pathological Complete Regression (pCR) rates, suboptimal sphincter preservation, increased distant metastasis, heterogeneous adherence to adjuvant chemotherapy, and limited long-term survival benefits. Further optimization of neoadjuvant treatment strategies holds promise for promoting tumor regression and improving prognosis. In neoadjuvant therapy, the extent of rectal tumor regression is highly dependent on radiotherapy, with higher radiation doses correlating with increased rates of pathological regression. This study aims to investigate the role of MRI-guided radiotherapy with a simultaneous integrated boost in enhancing tumor pCR in neoadjuvant treatment for locally advanced rectal cancer.

NCT ID: NCT06241703 Recruiting - Rectal Cancer Clinical Trials

Effect of ICCAUT Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery

ICCAUT-1
Start date: March 20, 2024
Phase: N/A
Study type: Interventional

In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.

NCT ID: NCT06239870 Recruiting - Clinical trials for Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer

Single-arm, Single-center, Exploratory Phase II Clinical Study of Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer

ESTIMATE
Start date: April 1, 2023
Phase: Phase 2
Study type: Interventional

Preoperative radiotherapy combined with 5-fluorouracil/capecitabine is currently the standard treatment for locally advanced rectal cancer. Although this strategy effectively reduces the risk of local recurrence, it fails to effectively improve the overall survival rate of patients . The root cause is that 5-fluorouracil/capecitabine based local radiotherapy is not effective in controlling potential micrometastases. Therefore, many studies try to combine preoperative radiotherapy with more intense chemotherapy and targeted drugs at the same time, as well as induction chemotherapy before preoperative radiotherapy and consolidation chemotherapy after, in order to obtain better efficacy. However, a number of studies have shown that increasing cytotoxic drugs fail to effectively improve pathologic complete response rate (pCR) and long-term survival rate, and significantly increase therapeutic toxicity . Therefore, the idea of trying to increase the efficacy of cytotoxic drugs by accumulating them does not work.Based on the use of PD-1/PD-L1 antibody in colorectal cancer and other solid tumors, and referring to the scheme of PD-1/PD-L1 antibody combined with radiotherapy in other solid tumors, we added envafolimab to local radiotherapy for advanced rectal cancer for exploration, with a view to further improving the pCR rate and long-term survival of patients.

NCT ID: NCT06234007 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study

Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.