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Stomach Neoplasms clinical trials

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NCT ID: NCT06257264 Recruiting - Breast Cancer Clinical Trials

A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

Start date: February 28, 2024
Phase: Phase 1
Study type: Interventional

This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-68501 in participants with advanced, nonresectable, or metastatic solid tumors. The study will also identify a recommended dose for expansion (RDFE) in subsequent disease directed studies. The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion) and Part 2 (dose expansion).

NCT ID: NCT06256705 Recruiting - Radiotherapy Clinical Trials

Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort

OPERANDI-NET
Start date: March 25, 2024
Phase: N/A
Study type: Interventional

Operandi project aims to address unmet clinical needs in the current management of GEP-NETs treated with PRRT by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and PRRT efficacy (genomic profiling, radiopotentiators, and new radionuclides). The study aim to identify predictive and early markers indicative of PRRT effectiveness based on a large prospective cohort of GEP-NET patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous PET-MRI. Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic PET-MRI at baseline, at middle course of PRRT and at 1 year of the beginning of PRRT, in patients with advanced GEP-NETs treated with PRRT.

NCT ID: NCT06256328 Recruiting - Gastric Cancer Clinical Trials

A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Start date: December 6, 2023
Phase: Phase 2
Study type: Interventional

This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

NCT ID: NCT06254300 Recruiting - Gastric Cancer Clinical Trials

Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer

On4Cancer
Start date: March 23, 2022
Phase: N/A
Study type: Interventional

Perioperative chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT4) is the standard perioperative treatment for resectable and advanced gastric adenocarcinoma. Although the FLOT4 regimen have shown increases in the overall survival, response rate, and progression-free survival, it is also associated with substantial toxicities. Prehabilitation is an effective strategy to improve physical fitness in cancer patients and reverse functional limitations and inadequate levels of physical activity that are associated with worse postoperative outcomes and treatment response. Therefore, the main objective of this study is to evaluate the effects of an online, supervised exercise-based prehabilitation program on the cardiorespiratory fitness level, functional fitness and quality of life among adults with gastric cancer undergoing neoadjuvant chemotherapy.

NCT ID: NCT06253897 Recruiting - Acromegaly Clinical Trials

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

BackSOM
Start date: May 29, 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 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: NCT06251973 Recruiting - Clinical trials for Metastatic Gastric Cancer

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

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

Participants will receive study treatment with agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel. When participants start each agent will depend on how their disease is affecting them.

NCT ID: NCT06250075 Completed - Gastric Cancer Clinical Trials

Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer

PRONIC-G
Start date: December 12, 2020
Phase: N/A
Study type: Interventional

The objective of this randomized controlled, prospective clinical study, composed of 5 groups, G1, G2, G3, G4 and G5 is [Evaluate the intestinal microbiota profile, nutritional, immunological status and inflammatory profile, before and after total or partial removal surgery (gastrectomies) for gastric cancer, in a patient using probiotic supplements.] The main questions it aims to answer are: - probiotics are capable of modulating the immune response and microbiota in cancer patients who will undergo surgery - surgery itself alters the immunological pattern and microbiota of cancer patients Participants will be divided into groups for evaluation and the G1 intervention group will take probiotic capsules. The researchers will compare groups G1, G2 with G3 (negative control group) to see if there are differences between using probiotics or not, in controlling the immune response and if there are significant changes in their intestinal microbiota. Groups G4 and G5 will also be compared, where in these we will only measure the power of the use of probiotics in reducing surgical complications in the postoperative period.

NCT ID: NCT06243757 Recruiting - Gastric Cancer Clinical Trials

A Study of Minimally Invasive Proximal Gastrectomy Versus Minimally Invasive Total Gastrectomy for Gastric and Gastroesophageal Junction Cancers

Start date: January 8, 2024
Phase:
Study type: Observational

Participants will a diagnosis of gastroesophageal junction (GEJ) adenocarcinoma and will have either a minimally invasive proximal gastrectomy (MIPG) or a minimally invasive total gastrectomy (MITG) as part of their routine care. Participants with complete a questionnaire 1 month before the surgical procedure and then 1, 3, 6 and 12 months after the surgical procedure.