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Locally Advanced Rectal Cancer clinical trials

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NCT ID: NCT06375434 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer

GMRSC-LARC
Start date: May 15, 2024
Phase:
Study type: Observational [Patient Registry]

The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy.

NCT ID: NCT06304987 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

Start date: April 2024
Phase: Phase 2
Study type: Interventional

This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer.

NCT ID: NCT06281405 Not yet recruiting - Neoadjuvant Therapy Clinical Trials

CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer

TORCH-iTNT
Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

NCT ID: NCT06204094 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

CASINOs
Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.

NCT ID: NCT06056804 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

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

This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.

NCT ID: NCT05998122 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study

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

Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.

NCT ID: NCT05794750 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC(AK104-IIT-13)

AK104-IIT-13
Start date: April 24, 2023
Phase: Phase 2
Study type: Interventional

This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with AK104 and chemotherapy + TME surgery in patients with advanced rectal cancer.

NCT ID: NCT05507112 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

TIME in Immunotherapy Combined With nCRT for Rectal Cancer

TIMENT-R
Start date: September 20, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

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: 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.