Clinical Research Directory

TAIC FOLFOX for Locally Advanced G/GEJA

Gastric cancer is the fifth most common malignancy worldwide in terms of both incidence and mortality. The majority of cases are diagnosed at advanced stage-often presenting with severe complications such as malignant stricture, obstruction, bleeding, and cancer-related malnutrition-which impinge on quality of life and survival outcomes. For patients with unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (G/GEJA), first-line systemic therapy remains predominantly platinum- and fluoropyrimidine-based combination chemotherapy, and targeted agents or immunotherapy can be added based on the expression of biomarkers. Under this standard approach, the median overall survival (mOS) for localized unresectable G/GEJA is approximately 14-20 months. For metastatic G/GEJA, the prognosis remains poor with an mOS of less than 1 year, despite the proven efficacy of chemotherapeutic agents. Moreover, up to 25% of cancer survivors report a significant decline in quality of life due to gastrointestinal symptoms during, soon after, or many years after treatment. Interventional oncology approaches-including trans-arterial infusion chemotherapy (TAIC), embolization (TAE), and chemoembolization (TACE)-represent promising locoregional therapeutic strategies. TAIC allows for the direct delivery of cytotoxic agents into the tumor-feeding arteries, thereby maximizing intra-tumoral drug concentration. As one of the most well-recognized applications, hepatic arterial infusion chemotherapy (HAIC) has been demonstrated in liver cancer by elevating local drug exposure, markedly enhancing antitumor efficacy while minimizing systemic adverse effects. Moreover, chemotherapeutic agents may exert secondary systemic activity against clinically or subclinically disseminated metastases upon systemic circulation, contributing to a sustained "secondary chemotherapy" effect. Owing to its favorable safety profile and preserved antitumor activity, TAIC is particularly suited for frail or elderly patients who are ineligible for surgery or conventional systemic chemotherapy. Given the persistent limitations of current therapeutic paradigms, the feasibility and safety of trans-arterial therapy in the treatment of anti-tumor, hemostasis and obstruction relief for locally advanced G/GEJC remains urgent. The present study aimed to assess the efficacy and safety of TAIC for locally advanced G/GEJA.

Two-component Radiology-guided Autonomous Cascade Engine (TRACE)

This study employed a prospective, randomised crossover trial design to evaluate the clinical utility of the TRACE artificial intelligence system for gastric cancer T-staging. A total of 54 radiologists from tertiary and non-tertiary hospitals, including both senior and junior practitioners, were enrolled. The study aimed to investigate whether AI-assisted diagnosis could improve the diagnostic accuracy of gastric cancer T-staging compared with independent interpretation by radiologists. All participants were required to interpret 60 contrast-enhanced CT cases sequentially, completing two readings for each case: one without AI assistance and one with AI assistance; The order of the two readings was randomised, and a one-month washout period was observed between readings to eliminate memory bias. All cases were pathologically confirmed gastric cancer cases (stages T1-T4b), and the study simultaneously recorded the physicians' T-staging diagnostic results and the time taken per case. The 60 cases per radiologist were randomly selected from a pool of 1,000 histologically confirmed gastric cancer cases, stratified by pathological T stage T1-T4b. The reference standard was postoperative pathological T stage. The primary outcome was the change in T-staging accuracy between AI-assisted reading and standard (unaided) reading.The term "prospective" in this study refers to the prospective execution of radiologist enrollment, randomization, reading procedures, and data collection.

REcovery After Cancer Application

The RECapp study is a clinical trial evaluating a digital tool designed to support patients recovering from surgery for oesophageal or stomach cancer. The goal is to reduce symptoms and improve quality of life during recovery. Each year in Sweden, around 1,400 people are diagnosed with these cancers. Although more people are surviving thanks to better treatments, recovery after surgery is often long and challenging, with lasting physical and emotional effects. At the same time, healthcare systems are under pressure to provide long-term support. RECapp is a digital platform developed together with patients and healthcare professionals. It includes a mobile app for patients and a web portal for healthcare staff. Patients can track their symptoms, receive personalised self-care advice, and get guidance on when to contact healthcare. Healthcare providers can follow patients' progress remotely. In this study, 250 patients from across Sweden will take part. They will be randomly assigned to either standard care or standard care plus RECapp. Participants will be followed for six months after surgery, and their symptoms and quality of life will be regularly assessed through questionnaires. If RECapp proves effective, it could become part of future cancer care in Sweden-helping patients feel better supported while also making care more efficient.

Exercise Training After Upper Gastrointestinal Cancer Surgery

This randomized controlled trial aims to determine the optimal exercise intensity for improving postoperative recovery in patients with upper gastrointestinal cancer. Participants who have undergone curative surgery will be randomly assigned to high-intensity interval training (HIIT), low-intensity continuous training (LICT), or usual care. The exercise interventions will be performed under supervision three times per week for eight weeks. The primary outcome is peak oxygen uptake (VO₂peak), assessed using cardiopulmonary exercise testing. Secondary outcomes include physical function, body composition, patient-reported outcomes, and biological and mechanistic markers such as inflammatory biomarkers, muscle-related factors, and gut microbiota. This study will also explore potential mechanisms underlying exercise-induced adaptations and their association with clinical outcomes.

Statewide Unified Network for Remote Intervention of Strength and Exercise

This study will evaluate whether a remotely delivered exercise program can improve chemotherapy tolerability in patients with gastrointestinal or lung cancer receiving chemotherapy. In this decentralized, digital randomized clinical trial, up to 120 adults with gastrointestinal or lung cancer will be randomized to either a home-based aerobic and resistance exercise program or home-based progressive stretching program. All study activities will be conducted remotely using digital technologies and home-based assessments. Participants in both groups will receive Bluetooth-enabled wearable devices for monitoring physical activity, body weight, blood pressure, and other health measures. The primary objective is to determine whether exercise improves chemotherapy relative dose intensity compared with stretching. The intervention will continue throughout chemotherapy treatment or for up to 32 weeks.

High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients

Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.

DeepComp for Prediction of Gastric Cancer Postoperative Complications (DeepComp-Prospective)

Gastric cancer is a leading cause of cancer-related mortality, and radical surgery remains the primary treatment. However, postoperative complications are common and can significantly impact patient recovery and quality of life. Currently, doctors lack precise tools to accurately predict which patients are at high risk for developing severe complications before surgery. This study aims to validate a novel artificial intelligence (AI) model called "DeepComp." The DeepComp model integrates clinical data with advanced radiomic features derived from routine preoperative CT scans. Specifically, it analyzes both the tumor characteristics and the patient's body composition (including skeletal muscle and fat distribution) to assess physiological reserve. In this prospective, multicenter observational study, researchers will enroll patients scheduled for gastric cancer surgery across five medical centers. The DeepComp model will be used to predict the risk of moderate-to-severe postoperative complications (Clavien-Dindo grade II or higher). These predictions will then be compared with the actual clinical outcomes observed 30 days after surgery. The goal is to determine the accuracy and reliability of the DeepComp model in a real-world clinical setting, potentially providing a powerful tool for personalized surgical risk assessment.

The UGIRA International Registry for RAMIG for Gastric Cancer

Minimally invasive gastrectomy (MIG) has gained in popularity, since it is feasible, safe and oncologically comparable to open gastrectomy, while morbidity and duration of hospitalization are reduced, quality of life is increased, and conversion rate is low. However, several challenges are faced during MIG, such as impaired depth perception and limited range of motion of instrument tips. Robot-Assisted Minimally Invasive Gastrectomy (RAMIG) can potentially overcome these challenges, while providing comparable results regarding safety, technical feasibility, morbidity and oncological effectiveness. However, the techniques and outcomes of RAMIG vary in literature, which can partly be explained by lack of uniform definitions of postoperative outcomes that would allow international comparison. Furthermore, RAMIG is technically demanding and therefore associated with a learning curve. To facilitate safe and effective implementation of RAMIG worldwide, the learning curve for RAMIG-procedures must be evaluated in detail. A prospective international registry with uniform data collection regarding surgical techniques and postoperative outcomes can provide a platform for multicontinental studies and the monitoring of surgical quality for surgeons who are implementing RAMIG in their center. Therefore, the aim of this study proposal is to expand the Upper Gastrointestinal International Robotic Association (UGIRA) collaboration by creating the UGIRA International Registry for RAMIG. The UGIRA network extends worldwide with members in Europe, Asia, North-America and South-America, therefore representing large-scale practice of RAMIG. The initial specific aims of the registry are to gain insight in surgical techniques and postoperative outcomes of RAMIG worldwide, and to evaluate the learning curve for RAMIG. Data for this registry is collected prospectively and retrospectively.

A Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma

This study is a domestic, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of heterogeneous radiotherapy (high and low dose) sequenced with iparomlimab and tuvonralimab plus SOX as a first-line treatment for unresectable locally advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Gastric Cancers in Algeria

The goal of this observational study is to describe the demographic, epidemiological, clinical, and outcome characteristics of patients with gastric cancer. It also aims to analyze the diagnostic approaches and management strategies used in the care of these patients in Algeria.

The Application of Extracellular Vesicle Detection in Gastric Juice Based on Metamaterial Sensing in the Diagnosis of Gastric Cancer and Related Diseases

After obtaining informed consent from the patients, all the medical history and treatment records of the patients who underwent gastroscopy since the onset of the disease, as well as gastric fluid samples, including laboratory and imaging data, were collected and recorded. The medical history and treatment records and gastric fluid samples were analyzed.

Peri-habilitation for Patients With Gastric Cancer

This study aims to evaluate the clinical applicability of a peri-habilitation program in patients with gastric cancer by applying nutritional intervention for approximately two weeks before surgery and a combined exercise and nutrition intervention for about three weeks after hospital discharge, and by analyzing its effects on the prevention of postoperative complications and recovery.

Screening and Validation of Serum Protein Biomarkers for Early Diagnosis of Gastric Cancer

This study focuses on the discovery of protein biomarkers for the early diagnosis of gastric cancer and the development of corresponding detection methods. By employing advanced mass spectrometry-based proteomic technologies, the investigators conducted an in-depth analysis of a large cohort of clinical samples to identify specific protein biomarkers capable of accurately distinguishing gastric cancer patients from healthy individuals. The findings from this research are expected to facilitate the development of novel non-invasive or minimally invasive diagnostic approaches, thereby improving early detection, enhancing patient prognosis, and increasing survival rates.

Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

Pathological biopsy before endoscopic submucosal dissection (ESD) the gastric lesion plays an important role in differentiating the pathological nature of the lesion and guiding treatment decisions. However, due to the influence of the materials used, the sensitivity of pathological biopsy is not satisfactory. Confocal Laser Endomicroscopy (CLE) is a technology that integrates a confocal microscope into an endoscope. It enables the acquisition of high-resolution microscopic images of the mucosal layer in real-time (with a magnification of up to 1000 times), and it is an optical biopsy technique. It has unique value in the determination of the pathological nature of gastric lesions. The main purpose of this study is to compare the sensitivity of pathological biopsy and CLE in differentiating the pathological nature of gastric lesions.