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Locally Advanced Rectal Cancer clinical trials

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NCT ID: NCT05086627 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer

Start date: October 15, 2022
Phase: Phase 2
Study type: Interventional

This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.

NCT ID: NCT05079503 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Gut Microbiome and Its Immune Modulation in Locally Advanced Rectal Cancer

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

To investigate dynamic change of gut microbiomes and metabolites, and their effects on immune modulation. To evaluate the efficacy and safety of TNT with GEN-001 (Lactococcus lactis) and identify predictive biomarkers for pathologic response in patients with locally advanced rectal cancer (LARC).

NCT ID: NCT05079438 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Dendrobium Huoshanense Suppository in Rectal Cancer

Start date: September 7, 2021
Phase: Phase 3
Study type: Interventional

To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.

NCT ID: NCT05076305 Not yet recruiting - Clinical trials for Recurrent Rectal Cancer

PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting

Start date: October 15, 2021
Phase:
Study type: Observational

The treatment of locally advanced and recurrent rectal cancers is highly individualized to each patient and their pattern of disease, and this decision is often made at the Multidisciplinary Team (MDT) meeting . The PelvEx collaborative was designed with the intent to provide greater international consensus on appropriate treatment decisions for this cohort. However, we propose that international variation exists in how certain patients will be evaluated, assessed and ultimately treated despite having the same disease. We plan to measure this variation in order to provide a greater understanding of the differences that exist.

NCT ID: NCT05054959 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

ICONA
Start date: June 24, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence

NCT ID: NCT04989855 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score

Start date: August 2021
Phase: Phase 2
Study type: Interventional

This is a prospective, one arm phase II study aimed to observe the efficacy and safety of tislelizumab combined with fruquintinib in treatment of patients with pMMR / MSS locally advanced rectal cancer with high immune score.

NCT ID: NCT04948762 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Start date: August 1, 2021
Phase:
Study type: Observational

Minimally-invasive surgery (MIS) techniques have revolutionised the approach to rectal cancer surgery. With increasing experience, surgeons have began to utilise these platforms increasingly in the context of pelvic exenteration (PE). This observational retrospective review plans to assess the volume of PE being performed on a global basis and to assess the comparative outcomes associated with each technique in order to assess the optimal approach to radical pelvic surgery.

NCT ID: NCT04906044 Active, not recruiting - Clinical trials for Locally Advanced Rectal Cancer

Total Neoadjuvant Treatment Plus PD-1 in Mid-Low Locally Advanced Rectal Cancer

STARS-RC03
Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

There have been many high-quality research publications, including the TNT model of short-term radiotherapy combined with consolidation chemotherapy, and the TNT model of three-drug combination with neoadjuvant chemotherapy with higher treatment intensity combined with CRT. All have achieved better tumor regression and tumor regression than the standard CRT model. The higher pCR rate reduces the recurrence and metastasis events, improves the prognosis, and strives for more opportunities for organ function preservation. Can the TNT model combined with immunotherapy further increase the cCR rate? Whether immunotherapy can bring further survival benefits to patients who develop CR after neoadjuvant therapy (especially W&W after cCR), it is also necessary to carry out corresponding clinical research. We designed this study for patients with mid-to-low and locally advanced rectal cancer who want to be able to preserve the anus. TNT mode combined with PD-1 immunotherapy is given before surgery, and TME surgery is performed on patients who have not reached cCR or who still require surgery. It provides sufficient evidence for the safety and effectiveness of preoperative neoadjuvant therapy for PD-1 in low- and middle-level locally advanced rectal cancer.

NCT ID: NCT04815694 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI Guided Radiotherapy

THUNDER2
Start date: March 17, 2021
Phase: N/A
Study type: Interventional

Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality in locally advanced rectal cancer (LARC) and patients achieving complete response to treatment (CR) usually have a better prognosis in terms of local control (LC), metastases-free survival (MFS) and overall survival (OS). Recently, an early tumour regression index (ERITCP) was introduced, to predict pathological CR (pCR) after nCRT in LARC patients. In particular, the authors found that the patients with ERITCP <13.1 show a strong response during therapy and have a lower probability to experience distant relapses. Aim of this clinical trial is to investigate the impact of dose escalation in rectal cancer, identifying the poor responder cases using the ERI index during the course of radiotherapy and increasing the prescribed dose in these patients. Adopting this boosting protocol, an increase of 10% of CR (clinical and pathological) rate is expected. For patients enrolled in the trial, chemoradiotherapy (CRT) will be administered using the MRI guided Radiotherapy (MRgRT) machine available in our institution. If ERI will be inferior than 13.1 the patient will continue the original treatment. Patients with complete clinical response will go through wait and see approach. If ERI will be higher than 13.1 the treatment plan will be reoptimized considering the residual tumor at fraction 10 as new therapy volume, where the dose will be intensified to reach 60.1 Gy. The number of cases to be enrolled will be 63. The primary endpoints will be complete response considered as: ypT0N0 in case of Total Mesorectal Excision (TME), ypT0ycN0 in case of LE, ycT0N0 in case of WW; prospective validation of delta radiomics MR-guide Radiotherapy model.

NCT ID: NCT04738214 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Development of a Genome-based Platform for Personalized Treatment in Locally Advanced Rectal Cancer Patients

Start date: February 2021
Phase:
Study type: Observational [Patient Registry]

This study is aimed to develop a genome-based platform to predict patients who can achieve pathologic complete response after neoadjuvant treatment in locally advanced rectal cancer. The main treatments for locally advanced rectal cancer is surgical removal such as lower anterior resection after neoadjuvant CCRT. About 10-40% of patients showed pathologic complete response after neoadjuvant CCRT. Mandard tumor regression grade (TRG) is used to grade the histologic tumor response after neoadjuvant treatment. TRG 1 represents the pathologic complete response and TRG2 as histologically small group of cancer cells. Accordingly, TRG1 and 2 are expressed as good responder. Even though the surgery is being performed as an essential treatment, there are various surgery-related sequelae such as colostomy. Also, in some patients, surgery may be refused or surgery may not be performed due to an underlying disease. About 15-20% of local recurrence was reported in patients who did not undergo surgery and the 3-year survival rate was 96.6%. Colorectal cancer genetically can be divided into 4-subtypes. With the recent development of genome testing technology, genome analysis has been actively conducted in colorectal cancer. The most commonly known genetic subtype of colorectal cancer is classified into a total of 4 types as consensus molecular subtype (CMS); CMS1, CMS2, CMS3, CMS4. However, this was analyzed in colorectal cancer patients who did not undergo radiotherapy. There is no data regarding the response to radiation therapy according to each genetic subtype. Therefore, classifying the subtypes through genomic analysis and studying the responsiveness to radiotherapy in each subtype is needed. In this study, we aimed to develop a platform that predicts pathologic tumor response after CCRT based on genomic information. Furthermore, being able to select patients who can wait-and-see without surgery using platform.