Clinical Research Directory

A Clinical Study on the Effect of Massaging Tian Tu Acupoint on Coughing After Esophageal Surgery

This study is a single-center, self-controlled trial. Patients will successively undergo voluntary coughing without intervention, a washout period, coughing stimulated by pressing the Tiantu acupoint, a washout period, and voluntary coughing without intervention. Vital signs of the patients before and after each cough will be recorded, as well as the changes in peak cough flow rate and intra-abdominal pressure after each cough. For peak cough flow rate and intra-abdominal pressure, three sets of data will be collected each time, and the best value will be taken. This pilot trial is conducted to verify the feasibility of the research design and to provide sample size estimation and data support for the main study.

Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)

This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.

Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.

Mayo Clinic Upper Digestive Disease Survey

The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Data will be used to establish the validation of the questionnaires/survey. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases. Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.

Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer

This multicenter prospective randomized clinical trial aims to compare the safety and oncological effectiveness of proximal gastrectomy and total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Eligible patients will be randomly assigned to undergo either proximal gastrectomy or total gastrectomy using open, laparoscopic, or robotic surgical approaches according to clinical suitability. The primary outcome of the study is 3-year disease-free survival. Secondary outcomes include postoperative mortality, postoperative complications, and the number of metastatic lymph nodes retrieved. Patients will be followed for up to five years after surgery to evaluate long-term oncological outcomes.

A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.

Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer

This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.

Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI

Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).

Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer

This is a randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate whether adding omega-3 fatty acids improves outcomes in adult patients with recurrent or metastatic esophageal cancer receiving PD-1 inhibitor therapy. The main questions are: Compared with placebo, does omega-3 (EPA+DHA) increase the longitudinal change in skeletal muscle index (ΔSMI) over 6 months? Does it improve clinical outcomes and favorably modulate immune and metabolic biomarkers as well as patient-reported outcomes ? Participants will be randomized 1:1 to: Intervention: Standard PD-1 therapy plus oral omega-3 (EPA 2.5 g + DHA 1.25 g per day) for 6 months. Control: Standard PD-1 therapy plus matching placebo for 6 months. Participants will attend study visits at baseline, 3 months, and 6 months (then every 3 months up to 2 years), undergo body composition and functional assessments, blood sampling, and questionnaires, and have treatment adherence assessed per protocol. Pre-specified exploratory biomarker analyses will be conducted to support mechanism research.

Endoscopic Resection of Gastrointestinal Neoplasms

The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.

Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques

This is a combined prospective and retrospective observational study aiming to validate a highly sensitive and specific blood-based method for the early diagnosis and post-treatment monitoring of multiple cancers. The study leverages a newly developed sequencing method to improve the detection of circulating tumor DNA (ctDNA) in blood, focusing on enhancing sensitivity and specificity in clinical applications. The study targets patients with ovarian, lung, pancreatic, colorectal, esophageal, breast, kidney, bladder, and gastric cancer, as well as healthy controls with asymptomatic gallstones, benign polyps, or individuals undergoing routine medical screening. Blood samples will be analyzed for cell-free DNA (cfDNA), RNA, and protein profiles. A key objective is to determine how much the newly developed method increases the sensitivity and specificity of ctDNA detection, especially in early-stage cancers and minimal residual disease (MRD) after treatment. The method evaluates the variant allele frequency (VAF) of ctDNA to detect residual disease and track tumor dynamics. Serial blood sampling will be conducted before and after surgery or chemotherapy and during follow-up outpatient visits in cancer patients, while one-time sampling will be done for controls. Additionally, tissue biopsies collected during surgery will be used to analyze concordance between tumor-specific mutations and those found in ctDNA. Primary outcome measures include quantitative differences in ctDNA or RNA levels between cancer and control groups. Secondary outcomes assess the clinical correlation between changes in ctDNA VAF and patient outcomes such as recurrence and survival. Statistical tools including ROC curve analysis, Cox regression, and log-rank tests will be used to quantify performance. This study seeks to establish a clinically robust, non-invasive diagnostic tool that enables earlier detection and more precise treatment decisions, while potentially reducing physical, psychological, and socioeconomic burdens related to cancer care.

HTL0039732 in Participants With Advanced Solid Tumours

The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.

Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy

This randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.

Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.

Esophageal cancer is the seventh most common type of cancer in the world, with an estimated global incidence of 604,100 new cases per year. The main symptom of esophageal cancer is dysphagia, associated or not with weight loss. Unfortunately, due to asymptomatic presentation in the early stages, more than half of patients are diagnosed in advanced stages of the disease, becoming ineligible for treatment with curative intent. In this sense, chemotherapy and radiotherapy are the pillars of palliative treatment, often regressing the injury and improving symptoms. However, some patients persist with dysphagia. In this scenario, esophageal prostheses are one of the main tools in the palliative treatment of esophageal cancer dysphagia, obtaining rapid and lasting relief of dysphagia. This study aims to compare fully covered (FC-SEMS) and partially covered (PC-SEMS) esophageal prostheses in this context, evaluating the number of reinterventions in each group, as well as the occurrence of adverse events. However, it is expected that with the data obtained it is possible to develop clearer and more effective protocols in the palliation of malignant dysphagia of esophageal stenosis.

Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections

This is a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophageal malignant neoplasms. Such substances are hyaluronic acid in the form of TS-905 Blue Eyeₒ and hydroxyethylamide (Voluven®).

The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study

To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions

Luso-Cor Stent Compared to Other Endoscopic Techniques for Management of Fistulas and Anastomotic Dehiscences(ES-LCCE-UDFM)

The global prevalence of obesity has prompted an increase in bariatric surgery, which is the only management strategy that provides long-term weight loss and improvement of obesity-related diseases. Bariatric surgeries include sleeve gastrectomy(SG), Roux-en-Y gastric bypass(RYGB),and laparoscopically adjustable gastric banding(LAGB). The incidence of adverse events depends on the type of bariatric surgery performed, with serious adverse events occurring in approximately 4% and mortality in 0.1% patients. The incidence of fistulas after SG varies between 0.2% to 2.5% and between 1% and 4.9% in patients who have undergone an RYGB. The incidence of strictures after SG is approximately 0.35%. Older, more obese, and male patients with multiple comorbidities related to obesity are at increased risk for the development of fistulas and mortality following bariatric surgery. Additionally, surgery after LAGB increases the risk of adverse events. This study will compare the efficacy and safety of the Luso-Cor esophageal stent versus conventional covered metallic stents versus endoscopic vacuum therapy in the management of fistulas and anastomotic dehiscences after oncologic or bariatric surgery on the stomach and esophagus.

Rehabilitation and Recovery for Persons with Esophageal or Gastric Cancer

This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.

Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) After Endoscopic Resection for Superficial Neoplasms

The goal of this clinical trial is to learn if tranilast works to prevent esophageal stricture after circumferential endoscopic submucosal dissection (cESD) in adults. It will also help us learn more about the safety of tranilast. The main questions it aims to answer are: 1. Does tranilast reduce the occurence of esophageal stricture in participants after cESD? 2. What medical problems do participants have when taking tranilast. Researchers will compare tranilast to prednisone (a steroid used in clinical practice with potential defects) to see if tranilast works well to prevent esophageal stricture. Participants will: 1. Take tranilast or prednisone every day for 8 weeks. 2. Attend visit (at clinic or phone) once every 2 weeks for checkups and tests until 16 weeks. 3. Keep a diary of their symptoms and let researchers know during the 16 weeks follow up.

Fruquintinib in Combination With Tislelizumab Followed by Radiotherapy in Esophageal Squamous Cell Carcinoma

According to the Global Burden of Disease Study, the number of esophageal cancer cases globally increased from 319,969 in 1990 to 534,563 in 2019, a relative increase of 67.07 per cent. In addition, GLOBOCAN 2020 reported that the global incidence of esophageal cancer climbed to 604,100, accounting for 3.1% of all tumor sites and ranking 7th out of 36 cancers. In addition, the number of global deaths from esophageal cancer increased from 319,332 in 1990 to 498,067 in 2019, a relative increase of 55.97%.GLOBOCAN 2020 reported about 544,076 new esophageal cancer deaths, which accounted for 5.5% of all study centres and ranked 6th among 36 cancers. Chemotherapy is the standard of care for advanced esophageal squamous cell carcinoma, but conventional chemotherapy has limited efficacy, and studies have shown lower median overall survival with chemotherapy in patients with advanced esophageal cancer compared to patients with other stages. In recent years, with the first-line approval of immune checkpoint inhibitors, the treatment of esophageal cancer has entered the immune era. Immune checkpoint inhibitors have become an important therapeutic option for patients with advanced esophageal cancer who have failed chemotherapy. This study will explore the efficacy and safety of this small molecule anti-angiogenic drug, fruquintinib, in combination with tislelizumab in esophageal squamous cell carcinoma previously treated with immune checkpoint inhibitors.

A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer

This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells. The four main aims of the clinical trial are to find out: 1. The best dose of UCB4594 that can be given safely to participants in the trial. 2. What the side effects of UCB4594 are and how they can be managed. 3. What happens to UCB4594 inside the body and how it affects cancer cells. 4. Whether UCB4594 can cause cancer to shrink.

Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers

This study is designed to perform a explorative search of the transcriptome to detect new circulating diagnostic sensitive and specific biomarkers in patients with Barrett's esophagus or esophageal adenocarcinoma.

PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer

The treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently. On this basis, the investigators intend to conduct a prospective, multicenter phase III clinical trial to assess whether radiotherapy with concurrent chemotherapy and immunotherapy could further improve the survival of patients with metastatic esophageal cancer. Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection (Including Whole Exome Sequencing and proteomics) to explore potential biomarkers for predicting outcomes, efficacy and toxicity.

Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)

Esophagectomy is the cornerstone of the curative treatment of esophageal carcinoma. Despite this treatment, patients can suffer from locoregional or distant metastatic disease and only a very selected group of patients can be cured: mostly those with recurrence in one single organ. Brain metastases are rare after esophagectomy for cancer, but they have a serious impact on survival. Agressive treatment is often moren difficult for brain metastases compared to other metastases and some risk factors have been identified earlier. There is an impression that the incidence of brain metastases in esophageal cancer patients has increased since the introduction of neoadjuvant treatment schemes. However, this is not clear yet. A potential explanation could be that chemotherapy disturbs the blood-brain-barrier, hereby facilitating the migration of tumor cells to the brain. The purpose of this study is to retrospectively analyze the incidence and potential risk factors of brain metastases in patients who underwent esophagectomy for esophageal cancer. Patients treated between 2000 and 2019 will be included and outcome parameters are Odds Ratio for brain metastases (comparison between primary surgery and neoadjuvant treatment followed by surgery), time to recurrence and risk factors, number and characteristics of the brain metastases.