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Esophageal Neoplasms clinical trials

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NCT ID: NCT04145726 Recruiting - Frailty Clinical Trials

Frailty In Thoracic Surgery for Esophageal Cancer

Start date: September 25, 2019
Phase:
Study type: Observational [Patient Registry]

Background: In Demark we se an increasing life expectancy and an increasing incidence of esophageal cancer and gastroesophageal junction (c.esophagus), with an average age of 65 years at diagnosis time. The consequence of this is an increased number of patients in need of esophageal resection. Esophageal cancer is currently treated with chemotherapy, radiotherapy and, whenever possible, esophageal resection. This multimodal treatment has increased survival, but is also associated with significant morbidity, mortality and adverse postoperative quality of life. At present, there is no standardized risk assessment for patients with c.esophagus who have to undergo esophageal resection. This study evaluates the preoperative risk using the frailty score system, CAF (comprehensive assessment of frailty) score, which identify patients being frail or not based on an assessment of the patient's physical condition. Purpose: Investigate how many patients that are frail undergoing esophageal resection. With the assumptions that CAF score can identify frail patients and that frail patients, have an increased risk of postoperative complications. With CAF score, we believe to become better of predicting complications following esophageal resection. Method: Prospective observational study of patients with c.esophagus undergoing esophageal resection. Plan to include 60 patients over one year period. The patients are deemed frail or not with the use of CAF score, which consist of various smaller physical test and questions. Postoperativley a follow-up after 30-days, six month and 12 month. At follow-up times, data are collected on the somatic readmissions / diagnoses and vital status. Afterwards we compare complications, mortality and quality of life in frail versus non-frail patients. Side effects, risks and disadvantages: At present, there is no standardized risk assessment used for preoperative risk assessment for patients with c.esophagus undergoing esophageal resection. The introduction of CAF score, will not expose patients to a risk or side effect, since the course or treatment does not change. Economy: We consider the study to be economically justified, since we hypothesize that this would lead to fewer readmissions, days of intensive care and shorter hospitalization. Acquisition: The patients will be 60 years or older and are undergoing esophageal resection. They will receive verbal- and written information preoperatively. At the first appearance they meet our project assistant who will answer any questions. Subsequently, the patients will be asked to sign a consent form. Publication of test results / research ethics statement: The knowledge and results gained through the research will provide essential scientific information of significans for the future course and treatment of patients undergoing esophageal resection in terms of number of hospital days, intensive days and readmissions.

NCT ID: NCT04140318 Recruiting - Clinical trials for Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma

Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma

Start date: November 15, 2019
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.

NCT ID: NCT04137679 Recruiting - Clinical trials for Unresectable Esophageal Cancer

Efficacy and Safety of Neo-CRT Followed Surgery Compared With Definitive CRT in Patients With Initial Unresectable ESO

Start date: November 1, 2019
Phase: Phase 2
Study type: Interventional

Definitive chemoradiotherapy(CRT) has been regarded as a standard of care for patients with unresectable locally advanced esophageal cancer. Patients who are sensitive to CRT can achieve significantly down staging. Whether this part of patients could benefit from further surgical treatment remains unknown. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive CRT versus neo-CRT plus radical resection in patients who achieved down staging after neo-CRT for stage T4NxM0 esophageal Cancer.

NCT ID: NCT04136236 Recruiting - Clinical trials for Artificial Intelligence

Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using pCLE With AI

Start date: August 1, 2019
Phase:
Study type: Observational

Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes. Probe-based confocal laser endomicroscopy (pCLE) can diagnose ESN accurately.However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.

NCT ID: NCT04135664 Recruiting - Esophageal Cancer Clinical Trials

Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma

Start date: September 1, 2019
Phase: Phase 3
Study type: Interventional

The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).

NCT ID: NCT04098796 Recruiting - Clinical trials for Gastric or Gastroesophageal Junction Adenocarcinoma

PD-1 Antibody + XELOX in 1st Line Serum A-fetoprotein (AFP)-Elevated Gastric or Gastroesophageal Junction Adenocarcinoma

Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma.

NCT ID: NCT04075305 Recruiting - Breast Cancer Clinical Trials

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

MOMENTUM
Start date: February 1, 2019
Phase:
Study type: Observational [Patient Registry]

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

NCT ID: NCT04074447 Recruiting - Esophageal Cancer Clinical Trials

The Efficacy of Immunodetection Point Inhibitors for Advanced Esophageal Cancer

Start date: May 1, 2019
Phase:
Study type: Observational

Esophageal cancer is one of the most common malignancies of the digestive system. Esophageal squamous cell carcinoma is the main type of esophageal cancer, accounting for more than 90% of esophageal cancer in China. The 5-year survival rate is about 15%~25%. Many patients with esophageal cancer are initially diagnosed as advanced, and many patients with early initial diagnosis will still relapse and metastasis after radical treatment. Currently, chemotherapy plays a central role in palliative care, but its objective remission rate is only 20-40%, and the median survival is about 8-10 months. However, most of the current phase III studies on targeted drugs for esophageal squamous cell carcinoma have failed, and the treatment of esophageal squamous cell carcinoma has entered the bottleneck stage. Therefore, it is urgent to explore a treatment method that can significantly improve the prognosis of patients with esophageal cancer. In recent years, with the development of biological immunotherapy, immunocheckpoint inhibitors, including pd-1 inhibitors, pd-l1 inhibitors and ctla-4 inhibitors, have achieved significant curative effect and made breakthroughs in the treatment of multiple solid tumors including melanoma, non-small cell lung cancer and kidney cancer. These immunocheckpoint inhibitors have also been tried for esophageal cancer, with initial success in immunotherapy for esophageal cancer. In this observational study, all patients with esophageal cancer who used immunocheckpoint inhibitors in clinical practice were included, without limitation on the number of treatment lines or combinations of different chemotherapy. Through follow-up observation, the purpose of this study was to analyze the efficacy of immunocheckpoint inhibitors for esophageal cancer in the real world, and to explore the differences in the efficacy of immunocheckpoint inhibitors in different stages of treatment, as well as the efficacy of different chemotherapy combinations, so as to provide clinical evidence for the use of immunotherapy for advanced esophageal cancer.

NCT ID: NCT04046575 Recruiting - Esophageal Cancer Clinical Trials

Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

Start date: November 7, 2019
Phase: Phase 1
Study type: Interventional

Rates of local disease control in patients with locally advanced esophageal cancer who are not candidates for surgical resection are suboptimal. Despite treatment with chemotherapy and radiation therapy approximately half of patients will develop recurrence of their cancer at the site of the original primary cancer. Salvage therapy options are largely ineffective and nearly all patients who develop local disease recurrence will succumb to their cancer. Recent clinical trials for lung cancer have demonstrated that local tumor control can be improved safely with accelerated hypofractionated radiation therapy regimens in order to achieve radiation dose intensification. This clinical trial aims to adapt those techniques and assess the safety of such a regimen for the treatment of inoperable thoracic esophageal cancers.

NCT ID: NCT04044859 Recruiting - Ovarian Cancer Clinical Trials

ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)

Start date: August 20, 2019
Phase: Phase 1
Study type: Interventional

This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.