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Showing 1-20 of 44 trials
NCT07537348
Based on existing literature, we posit that a leucine-restricted diet is safe and well-tolerated in patients with advanced gastric cancer receiving combined chemotherapy and immunotherapy. Patients adhering to this dietary regimen exhibit a significant reduction in serum leucine concentrations, with no notable impact on the serum levels of other amino acids. Furthermore, leucine restriction promotes the activation of immune cells within the tumor microenvironment. When applied in conjunction with chemotherapy and immunotherapy for advanced gastric cancer, this approach demonstrates synergistic anti-tumor efficacy. It is expected to enhance tumor response rates , improve the 1-year survival rate, prolong overall survival (OS), and ultimately optimize patient prognosis.
NCT07529808
This study is looking at how safe BHB810 is in adults with gastroesophageal adenocarcinoma (GEA) and other gastrointestinal (GI) cancers. The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.
NCT07486310
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, planned to enroll 30 patients with advanced gastric cancer and peritoneal metastasis. It aims to evaluate the safety and efficacy of systemic therapy plus Pressurized Intra-Peritoneal Aerosol Virus (PIPAV) with VRT106 compared to systemic therapy plus Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC).
NCT07259226
International study that will evaluate the association of prespecified biomarkers with resistance to Antibody-drug conjugates (ADCs), a type of targeted cancer treatment currently used in clinical practice for treating different tumor types.
NCT07102901
This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
NCT06947291
The trial consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (proof-of-concept study). Among them, Stage 2 adopts a randomized, controlled, open-label, and multicenter design.
NCT07144995
This anchored matching-adjusted indirect comparison (MAIC) evaluates the relative efficacy of fruquintinib-paclitaxel (using IPD from the FRUTIGA trial, n=703) versus ramucirumab-paclitaxel (using published AgD from RAINBOW-Asia, n=440) in advanced gastric/GEJ adenocarcinoma. Baseline characteristics are adjusted via entropy balancing weights. Primary endpoint is progression-free survival (PFS) analyzed by Bucher method; secondary endpoints include overall survival (OS) and objective response rate (ORR). Sensitivity analyses comprise restricted mean survival time (RMST) analysis and simulated treatment comparison (STC).
NCT06941168
This multicenter retrospective cohort study aimed to evaluate the potential advantages of robotic total gastrectomy (RTG) compared to laparoscopic total gastrectomy (LTG) in patients with advanced middle and upper gastric cancer (AMUGC). A total of 1,099 patients who underwent radical total gastrectomy between 2013 and 2020 were included. After strict inclusion and exclusion criteria, propensity score matching (1:1) was conducted to balance baseline characteristics. The primary endpoint was 3-year disease-free survival (DFS), with secondary outcomes including overall survival, recurrence rates and patterns, and perioperative outcomes. All procedures were performed by experienced surgeons following standardized protocols across eight high-volume centers. Data quality was ensured through a centralized electronic system, unified training, and rigorous verification. This study provides real-world evidence on surgical outcomes and long-term prognosis, contributing to clinical decision-making in the treatment of AMUGC.
NCT02142322
This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.
NCT03609359
The efficacy and safety of the use of pembrolizumab in combination with lenvatinib.
NCT04195828
To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate, nab-paclitaxel and S-1
NCT06767436
* Institutions will be selected * This study aims to collect real-world data, targeting patients who started treatment with Enhertu from September 2022, for clinical data collection * Among patients treated with Enhertu, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024 * For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration) * Efficacy evaluation
NCT06727981
This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes
NCT06592287
This study is a prospective, dual arm, open Ib/II phase clinical trial, with the main objective of exploring the safety and efficacy of Adebrelimab combined with Apatinib and Lrinotecan liposome for second-line treatment of advanced gastric cancer. The study is divided into two stages. The first stage is the safety introduction period, which includes 6 patients. Observe whether the subjects experience dose limiting toxicity (DLT) during the observation period. If no subjects experience DLT during the observation period, the study enters the next stage. The dose of Lrinotecan liposome used during the safety introduction period is 80mg/m2, and the DLTs observation period is 1 cycle. If the patient cannot tolerate it, the dose will be reduced to 60mg/m2. In the second stage, advanced gastric cancer subjects who have progressed to first-line treatment will be included in two cohorts: those who have previously received immune checkpoint inhibitor therapy and have first-line PFS\>7m (cohort 1) and those who have received standard systemic chemotherapy (cohort 2). 30 subjects will be included in each population, and a total of 66 subjects are planned to be enrolled. The study includes a screening period (from the signing of the informed consent form by the subjects to the first treatment, not exceeding 28 days), a treatment period (Adebrelimab combined with Apatinib and Lrinotecan liposome), and a follow-up period (including safety and survival follow-up).
NCT06486545
Liposomal irinotecan, intravenous infusion 90min, d1: Grade 1:50mg/m2 Grade 2:60mg/m2 Grade 3:70mg/m2 Albumin-paclitaxel, 150mg/m2, intravenous infusion, d1 DLT was observed for 2 weeks (the first cycle). The same subject received only one dose of liposomal irinotecan during the study. All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy. If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks, the subject may continue to receive treatment for metastatic disease. The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed. Until there is a possibility of surgery, disease progression, intolerable toxicity or the patient withdraws informed consent (whichever comes first).
NCT06478394
Brief Summary: Machine Learning-Driven Noninvasive Screening of Transcriptomics Liquid Biopsies for Early Diagnosis of Occult Peritoneal Metastases in Locally Advanced Gastric Cancer Gastric cancer, commonly known as stomach cancer, is a significant health issue worldwide, especially when it progresses to an advanced stage. One of the major challenges in treating locally advanced gastric cancer (LAGC) is the detection of occult (hidden) peritoneal metastases. These metastases are cancer cells that spread to the peritoneum (the lining of the abdominal cavity) but are not easily detectable with standard imaging techniques or during surgery. Early and accurate detection of these hidden metastases can significantly improve treatment strategies and outcomes for patients. This clinical study explores an innovative approach to tackle this problem using machine learning (ML) technology and liquid biopsies. Liquid biopsies are a noninvasive method that involves analyzing blood samples to detect cancer-related biomarkers, such as circulating tumor DNA or RNA. This study specifically focuses on the transcriptomics of liquid biopsies, which refers to the analysis of RNA molecules to understand the gene expression profiles associated with cancer. Hypothesis The hypothesis of this study is that machine learning algorithms can effectively analyze transcriptomics data from liquid biopsies to detect occult peritoneal metastases in patients with locally advanced gastric cancer. By doing so, this method could provide a noninvasive, accurate, and early diagnosis of metastases, which are otherwise difficult to identify through traditional methods. Study Design 1. Participants: The study will enroll patients diagnosed with locally advanced gastric cancer. These patients will undergo standard diagnostic and staging procedures to confirm their cancer stage and overall health status. 2. Sample Collection: Blood samples will be collected from the participants at various stages of their treatment journey. These samples will be processed to extract RNA, which will then be analyzed to obtain transcriptomic data. 3. Machine Learning Analysis: Advanced machine learning algorithms will be employed to analyze the transcriptomic data from the liquid biopsies. The algorithms will be trained to identify patterns and markers associated with occult peritoneal metastases. The models will be continuously refined and validated using a subset of the collected data to ensure accuracy and reliability. 4. Comparison with Traditional Methods: The results of the machine learning analysis will be compared with the outcomes of traditional diagnostic methods, such as imaging and surgical examinations, to evaluate the effectiveness of the ML-driven approach. 5. Outcome Measures: The primary outcome measure will be the accuracy of the machine learning models in detecting occult peritoneal metastases compared to traditional methods. Secondary measures will include the impact of early detection on treatment decisions, patient outcomes, and overall survival rates. Significance Early and accurate detection of occult peritoneal metastases in locally advanced gastric cancer is crucial for effective treatment planning. Traditional diagnostic methods often fail to identify these hidden metastases until they have progressed, limiting the treatment options and adversely affecting patient prognosis. By leveraging machine learning technology to analyze transcriptomics data from liquid biopsies, this study aims to develop a noninvasive and reliable screening tool that can detect these metastases at an earlier stage. Such an advancement could lead to several benefits, including: * Improved Treatment Planning: Early detection allows for more tailored and effective treatment strategies, potentially including more aggressive therapies or surgical interventions when necessary. * Better Patient Outcomes: With earlier and more accurate diagnosis, patients have a higher chance of receiving timely and appropriate treatments, which can improve survival rates and quality of life. * Noninvasive Screening: Liquid biopsies are less invasive than traditional biopsy methods, reducing the physical and psychological burden on patients. * Cost-Effectiveness: Early detection and treatment can potentially reduce the overall cost of care by preventing the need for more extensive and expensive treatments at later stages of the disease. Conclusion This clinical study represents a promising step forward in the fight against gastric cancer. By integrating machine learning with noninvasive liquid biopsy techniques, it aims to provide a new tool for the early detection of occult peritoneal metastases, ultimately improving outcomes for patients with locally advanced gastric cancer. The success of this study could pave the way for broader applications of machine learning in cancer diagnostics and personalized medicine.
NCT06235164
To evaluate the safety and effectiveness of laparoscopic gastrectomy (LG) following neoadjuvant immunochemotherapy (nICT)
NCT06169410
Abstract Objective: Ramucirumab is a VEGFR2 antagonist. The aim of this trial is to evaluate the efficacy and safety of ramucirumab combined with nab-paclitaxel, lobaplatin and S-1 in neoadjuvant and conversion therapy for advanced gastric cancer. Methods and analysis: This study is a prospective single-center, randomized controlled and open label clinical study containing two cohorts with 140 patients of advanced gastric cancer (Cohort A n=70; Cohort B n=70). The main efficacy indicator is pathological complete response (pCR) of the cancer after neoadjuvant or conversion therapy. The secondary efficacy indicators are R0 resection rate after neoadjuvant or conversion therapy, the incidence of adverse events (AE), progression-free survival (PFS), overall survival (OS), objective response rate (ORR), total response rate and total response time, disease control rate (DCR) and duration of overall response (DOR). Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20232220-F-1).
NCT06123494
This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry \[IHC\] 3+ or IHC 2+/in situ hybridization \[ISH\]+) gastric or GEJ adenocarcinoma (based on \[American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines who have progressed on or after a first-line anti-HER2 therapy-containing regimen.
NCT02935634
The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with advanced gastric cancer.