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Stomach Neoplasms clinical trials

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NCT ID: NCT06275997 Not yet recruiting - Gastric Cancer Clinical Trials

GAIN Project: Gastric Cancer and Artificial Intelligence

GAIN
Start date: March 2024
Phase: N/A
Study type: Interventional

Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion. The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4).

NCT ID: NCT06266871 Not yet recruiting - Gastric Cancer Clinical Trials

SOX Combined With Tislelizumab and LDRT for Neoadjuvant Treatment of Locally Advanced Gastric Cancer

Start date: March 10, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer.

NCT ID: NCT06263088 Not yet recruiting - Esophageal Cancer Clinical Trials

EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.

Start date: July 2024
Phase: N/A
Study type: Interventional

This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin). This study has 3 components as follows- 1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment. 2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant. 3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis.

NCT ID: NCT06253897 Not yet recruiting - Acromegaly Clinical Trials

A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly

BackSOM
Start date: March 26, 2024
Phase:
Study type: Observational

Participants of this study are adults with GEP-NETs and/or acromegaly who were using the Ipsen lanreotide syringe and have transitioned in the last 6 months to the Pharmathen lanreotide syringe, having received at least two injections using the Pharmathen syringe. GEP-NETs are abnormal growths that develop in the digestive system, including the stomach, intestines, and pancreas. These tumors arise from special cells called neuroendocrine cells, which are found in these organs and release hormones to regulate various bodily functions. GEP-NETs can be slow-growing, and symptoms may vary depending on their location and size. Acromegaly is a condition where a person's body produces too much growth hormone. This excess hormone can cause certain body parts, like the hands, feet, and face, to enlarge over time. It typically occurs because of a tumor on the pituitary gland in the brain, which is responsible for regulating hormones. Acromegaly can lead to various health issues if not treated, but medications or surgery can often help manage the condition. Long-acting somatostatin analogs (LA-SSAs) are indicated for patients with Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and acromegaly who are not eligible for surgery or when surgery fails to achieve remission. Data for this study will be collected after the treatment switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe has occurred, using one round of one-to-one qualitative telephone and/or videoconference interviews with patients. Interviews will last 45 minutes and be carried out in the local language of the participant's country. The main aim of this study is to capture the patient experience of the Ipsen lanreotide syringe and their experience with the Pharmathen lanreotide syringe.

NCT ID: NCT06253650 Not yet recruiting - Gastric Cancer Clinical Trials

Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease

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

TRINITY is designed as a multicentre, randomized, open-label, interventional phase II study aimed at investigating the activity, efficacy and safety of trastuzumab-deruxtecan (T-DXd) plus capecitabine/5-fluorouracil as a post-operative treatment in localized/locally advanced gastric or gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma patients with HER2 overexpression/amplification and positive post-operative ctDNA after pre-operative 5-fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) regimen followed by radical surgery.

NCT ID: NCT06253611 Not yet recruiting - Gastric Cancer Clinical Trials

First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer

BIG
Start date: March 2024
Phase: Phase 2
Study type: Interventional

This is a randomized non-comparative, multicenter phase II study in patients with PD-L1 PD-L1 combined positive score (CPS) ≥5 advanced gastric cancer to evaluate the efficacy and safety of nivolumab and FOLFOX in combination with EXL01 as first-line treatment. After signing the informed consent form, and upon confirmation of the patient's eligibility, patients will be randomized in a 2:1 ratio to either the nivolumab and FOLFOX plus EXL01 arm (experimental) or the nivolumab and FOLFOX arm (control). In both arms, treatment will be given until PD, unacceptable toxicity or for a maximum of 24 months (52 cycles).

NCT ID: NCT06238167 Not yet recruiting - Gastric Cancer Clinical Trials

Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With LA GC/GEJC

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

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with tislelizumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or tegafur-gimeracil-oteracil potassium + oxaliplatin (SOX therapy) in PD-L1 CPS positive, elderly (≥70years old), pStage III gastric cancer (including esophagogastric junction cancer) after D2 dissection.

NCT ID: NCT06232434 Not yet recruiting - Clinical trials for Gastric Cancer With Peritoneal Dissemination

An Open Prospective Randomized Clinical Study of the Effectiveness, Tolerability and Safety of a Single Intraperitoneal Use of the Drug "Prospidelong, Powder for the Preparation of a Gel for Topical Use, 1000 mg in Vials, Package No. 1" in Patients With Disseminated Gastric Cancer, Phase I-II

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Start date: June 2024
Phase: Phase 2/Phase 3
Study type: Interventional

It is planned to conduct an open-label, prospective, randomized clinical study of the efficacy, tolerability and safety of a single intraperitoneal administration of the investigational drug Prospidelong at a dose of 4000 mg (2000 mg in terms of prospidium chloride) in patients with disseminated gastric cancer. In total, the study plans to include 120 patients aged 18 to 75 years inclusive, including 60 patients in the study group and 60 in the comparison group. The study consists of daily examination of patients throughout the entire period of hospitalization and subsequent visits.

NCT ID: NCT06229197 Not yet recruiting - Gastric Cancer Clinical Trials

Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer

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

The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.

NCT ID: NCT06227325 Not yet recruiting - Gastric Cancer Clinical Trials

Disitamab Vedotin Combined With Sintilimab and XELOX Perioperative Treatment for Resectable Gastric Caner With HER2 Overexpression

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

The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of RC48 combined withSintilimab and chemotherapy in perioperative therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.