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Rectal Neoplasms clinical trials

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NCT ID: NCT05912075 Recruiting - Clinical trials for Locally-advanced Rectal Cancer

Preoperative Radiotherapy And ASTX660 in Rectum Cancer

PRAAR1
Start date: December 19, 2023
Phase: Phase 1
Study type: Interventional

Compare two arms: - Chemotherapy followed by tolinapant (ASTX660) in combination with Long-Course Radio Chemotherapy (LCRT), and - Tolinapant (ASTX660) in combination with Short-Course Radiotherapy (SCRT) followed by chemotherapy For each patient, the treatment arm will be allocated on the following basis: patients will be allocated to the chemotherapy followed by LCRT arm unless they present at least one of the following criteria: contraindication to receive mFOLFIRINOX (including intolerance to irinotecan and UGT1A1*28 polymorphism), age > 75, general condition incompatible with the radiotherapy schedule of LCRT. In such case, patients will be allocated to the SCRT arm. Tolinapant (ASTX660) will be administered orally once a day for 7 consecutive days every other week during 10 weeks (One week On / One week Off during 10 weeks). Both treatment arms will have a dose escalation part to determine the MTD and/or RP2D, followed by an expansion part where up to 21 subjects will be dosed at the RP2D. Both arms will enroll simultaneously.

NCT ID: NCT05887531 Recruiting - Prehabilitation Clinical Trials

Abdominopelvic Cancer Prehabilitation

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The main objective of this research is to determine the effectiveness of a Prehabilitation consultation in self-care and physical exercise aimed at patients diagnosed with abdominopelvic cancer with initial surgical indication as part of their therapeutic plan.

NCT ID: NCT05883800 Recruiting - Rectal Cancer Clinical Trials

Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

TNT-RECORD
Start date: June 22, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05877573 Recruiting - Rectal Cancer Clinical Trials

Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. 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: NCT05876026 Recruiting - Rectal Cancer Clinical Trials

MRI T1 Relaxation Time in Rectal Cancer

Start date: May 8, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the T1 relaxation time and T1 relaxation time properties of the disease in people with locally advanced rectal cancer. The main question it aims to answer is: Does MRI T1 relaxation time have a high diagnostic performance in recognizing fibrosis as a complete response to neoadjuvant treatment of rectal cancer? Participants will receive standard neoadjuvant treatment and be part of the standard examination programme regarding rectal cancer.

NCT ID: NCT05873621 Recruiting - Rectal Cancer Clinical Trials

Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy

(GreenEye-CRC)
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The main questions it aims to answer are: - Does the use of ICG increase the total number of harvested lymph nodes? - Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes? Participants will intraoperatively receive a trans-anal administration of ICG near to rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. A comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of ICG.

NCT ID: NCT05871762 Recruiting - Rectal Neoplasms Clinical Trials

Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer

COMREC
Start date: June 4, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.

NCT ID: NCT05856305 Recruiting - Rectal Neoplasms Clinical Trials

SCRT in TNT With or Without Chlorophyllin

SCOTCH
Start date: July 5, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to see, if addition of chlorophyllin to neoadjuvant Chemo-radiotherapy can reduce the gastro-intestinal/genitourinary/hematological toxicity rates and improve the quality of life in patient's diagnosed with locally advanced rectal cancer. This is a randomized placebo control trial, wherein participants randomized to Chlorophyllin arm will receive the drug of interest along with the standard treatment. Participants randomized to other arm will receive placebo along with the standard treatment. Researchers will compare the difference between the outcomes from both the arms and will also observe the non-operative management success rates.

NCT ID: NCT05845268 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Total Neoadjuvant Therapy Combined With Tislelizumab for Local Advanced of Middle and Low Rectal Cancer

Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT05815303 Recruiting - Rectal Cancer Clinical Trials

XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer

Start date: March 29, 2023
Phase: Phase 2
Study type: Interventional

This is a two-arm, open label, randomized phase II clinical study. The aim is to evaluate the safety and efficacy of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) combined with XELOX regimen in pMMR locally advanced rectal cancer during the perioperative period. Eligible patients will receive either Cadonilimab plus XELOX or XELOX alone for 4 cycles before and 4 cycles after surgery. The primary endpoint is the pathological complete response rate.