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Esophageal Neoplasms clinical trials

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NCT ID: NCT06469060 Not yet recruiting - Esophageal Cancer Clinical Trials

Neoadjuvant Immunochemotherapy for Adenocarcinoma of the Esophagogastric Junction

TRACE
Start date: June 19, 2024
Phase: Phase 2
Study type: Interventional

The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of a modified neoadjuvant immunotherapy plus chemotherapy (one cycle of Tislelizumab monotherapy followed by four cycles of Tislelizumab plus Docetaxel, Oxaliplatin and Capecitabine) in patients with locally advanced resectable adenocarcinoma of the esophagogastric junction (AEG).

NCT ID: NCT06468800 Not yet recruiting - Clinical trials for Oesophageal Neoplasm

Feasibility and Added Value of the TRACMOTION Device for ESD

TRACMOTION
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

A single center non-randomized prospective clinical study, to evaluate the feasibility and added value of the CE-certified Tracmotion device in patients scheduled consecutively for ESD in the upper and lower gastrointestinal tract. After ESD, the endoscopists' opinion will be evaluated with a short questionnaire on experience with the Tracmotion device. The pathology report will be checked for radicality and microscopic damage of the removed lesion.

NCT ID: NCT06445972 Not yet recruiting - Esophageal Cancer Clinical Trials

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

Start date: July 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of MK-2870 plus paclitaxel 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.

NCT ID: NCT06437288 Not yet recruiting - Esophageal Cancer Clinical Trials

Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

Start date: May 31, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the effectiveness of photodynamic therapy using hematoporphyrin injection in treating recurrent or residual superficial esophageal cancer. The primary purpose is to assess the ability of this intervention to achieve complete response in these patients. The main question it aims to answer is: - What is the complete response rate at day 28 post-treatment with PDT using hematoporphyrin injection in patients with recurrent or residual superficial esophageal cancer? There is no comparison group in this single-arm study. Participants will: - Be adults aged 18-80 with recurrent or residual superficial esophageal cancer after prior treatment. - Receive an intravenous infusion of hematoporphyrin injection at a dose of 3mg/kg over 60 minutes. - Undergo 630nm laser irradiation 48-72 hours after the infusion. - Be assessed for complete response at day 28 post-treatment, as well as progression-free survival, overall survival, swallowing function, quality of life, and adverse events throughout the study.

NCT ID: NCT06435286 Not yet recruiting - Clinical trials for Suspected or Known Squamous Cell Neoplasia

Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States

Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p <0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.

NCT ID: NCT06423885 Not yet recruiting - Clinical trials for HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

A Study of BL-M07D1+PD-1 Monoclonal Antibody and BL-M07D1+PD-1 Monoclonal Antibody+Capecitabine in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

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

This study is a multicenter, open-label, phase II clinical trial to evaluate the safety and efficacy of BL-M07D1+PD-1 monoclonal antibody and BL-M07D1+PD-1 monoclonal antibody+ capecitabine in patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

NCT ID: NCT06418945 Not yet recruiting - Clinical trials for Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas Gingivalis

Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery

Start date: August 1, 2024
Phase: Phase 3
Study type: Interventional

Esophagectomy is an important means of radical treatment of esophageal cancer, but due to local recurrence and metastasis, the 5-year survival rate of patients with esophageal cancer is only 20-30%. Studies have reported that about 50% of patients relapse within 1 year after surgery, and the short-term recurrence rate is high. Therefore, reducing the recurrence rate of esophageal cancer after operation is an important way to improve its prognosis. Porphyromonas gingivalis infection in ESCC tissues was significantly higher than that in paracancer tissues, and was significantly positively correlated with cancer cell differentiation, lymph node metastasis, TNM stage, and shortened survival of ESCC patients. In summary, porphyromonas gingivalis plays an important role in postoperative recurrence of esophageal cancer. Elimination of porphyromonas gingivalis can significantly reduce the recurrence rate of esophageal cancer after operation. Tinidazole is a class of nitroimidazole drugs. It has been pointed out that the pharmacological mechanism of Tinidazole is to inhibit the DNA synthesis of pathogenic bacteria, so as to eliminate bacteria in periodontal tissues and inhibit local inflammation. Based on this, we designed and fabricated a novel oral microneedle patch loaded with tinidazole. Tinidazole oral microneedle patch can effectively remove porphyromonas gingivalis and promote the repair of gingival tissue. In this study, based on the combination of mechanical removal and antibacterial treatment, a combination of ultrasonic dental cleaning and tinidazole oral composite microneedle patch was designed to completely remove porphyromonas gingivalis in oral cavity, and to evaluate the effect of removal of porphyromonas gingivalis in oral cavity on the prognosis of esophageal cancer after radical surgery.

NCT ID: NCT06418516 Not yet recruiting - Clinical trials for Head and Neck Cancer

Early Detection of Esophageal Squamous Cancer With the Capsule Sponge Device

ANGELA
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Esophageal squamous cell carcinoma accounts for ~90% of the nearly half-million annual incident cases of esophageal cancer worldwide. The high costs and invasiveness of upper endoscopy constitute a limitation in providing adequate surveillance for at-risk individuals, including those with previous head and neck cancer. The ANGELA study is a prospective evaluation of the minimally-invasive capsule-sponge device, coupled with tissue biomarkers (p53-immunohistochemistry), to detect squamous neoplasia in high-risk individuals.

NCT ID: NCT06414902 Not yet recruiting - Esophageal Cancer Clinical Trials

18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chemoradiation Treatment Response in Esophageal Cancer

Start date: November 29, 2024
Phase: Early Phase 1
Study type: Interventional

To learn if 18F-FAraG PET scans can find tumors in participants with esophageal cancer and predict a participant's response to treatment.

NCT ID: NCT06412419 Not yet recruiting - Clinical trials for Esophageal Neoplasms Malignant

Multimodal Endoscopic Image Fusion for Assessing Infiltration in Superficial Esophageal Squamous Cell Carcinoma

Start date: May 15, 2024
Phase:
Study type: Observational

The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the extent of esophageal cancer invasion than what is currently possible with ultrasound technology. This research endeavors to harness the synergy of endoscopic ultrasound (EUS) and Magnifying endoscopy, augmented by the pattern recognition and correlation capabilities of artificial intelligence (AI), to detect early esophageal squamous cell carcinoma and its invasiveness, along with high-grade intraepithelial neoplasia. The overarching goal is to ascertain the potential and significance of this approach in the early detection of esophageal cancer. The project's primary goals are to develop three distinct AI-assisted diagnostic systems: An AI-driven electronic endoscopic diagnosis system designed to autonomously identify lesions. An AI-based EUS diagnostic system capable of automatically delineating the affected areas. A multimodal diagnostic framework that integrates electronic endoscopy with EUS to enhance diagnostic accuracy and efficiency.