Clinical Research Directory

Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV)

This is a Phase II clinical study for people with stage IV cancer. The study will evaluate the use of stereotactic body radiation therapy (SBRT), a type of focused radiation treatment, together with immunotherapy-based treatment. SRBT will be used to treat multiple areas of cancer that have spread to other parts of the body. The study will evaluate whether this treatment approach can be safely given while patients continue their planned cancer treatment and may help control their cancer.

Anti-PD-1 in Combination With Systemic Chemotherapy With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites

This prospective observational study aims to evaluate the efficacy and safety of anti-PD-1 therapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel as first-line treatment for patients with advanced gastric or gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites. The study will also explore potential predictive biomarkers of treatment response through longitudinal collection and multi-omics analysis of tumor tissue, peripheral blood, and ascites.

TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)

The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS) works to help people recover faster after laparoscopic surgery for stomach cancer. TEAS is a treatment that uses small electrical pulses through sticky pads on the skin. It does not use needles. The main questions it aims to answer are: Does TEAS help people pass gas (a sign that the digestive system is waking up) sooner after surgery? Does TEAS help lower pain after surgery? Does TEAS reduce the need for extra pain medication after surgery? Researchers will compare three groups to see if TEAS works better when given before, during, and after surgery compared with only after surgery. Group 1 receives TEAS before, during, and after surgery. Group 2 receives a sham (inactive) treatment before and during surgery, and real TEAS after surgery. Group 3 receives sham treatment at all time points. All participants will receive the same standard pain relief and recovery care after surgery. Participants will: Be randomly assigned (like flipping a coin) to one of the three groups Receive TEAS or sham treatment for 30 minutes before surgery, during surgery, and for 30 minutes each day on the first 3 days after surgery Rate their pain on a 0-10 scale at 6, 12, 24, 48, and 72 hours after surgery Complete quality-of-life questionnaires before surgery, on day 4 after surgery, and 30 days after surgery Have a follow-up visit or phone call 30 days after leaving the hospital This study includes 300 adults aged 18 to 80 years who are scheduled to have laparoscopic surgery for stomach cancer at 13 hospitals in Shandong Province, China.

Safety and Efficacy of NK510 to Treat Gastric Cancer and Colorectal Cancer

This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated.

A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects With Select Advanced Solid Tumors

A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects with Select Advanced Solid Tumors. The main goals of this study are to: * Find the recommended dose of TS-104 that can safely be given to participants * Learn more about the side effects of TS-104 * Learn more about the effectiveness of TS-104 * Learn more about the pharmacokinetics of TS-104

Multimodal Prehabilitation in Gastric Cancer Patients

This single-arm phase II trial investigates whether a multimodal prehabilitation program can attenuate the postoperative inflammatory response in patients undergoing curative gastric cancer surgery. Major abdominal surgery induces a pronounced systemic inflammatory reaction that contributes to postoperative complications, delayed recovery, impaired functional status, and reduced tolerance to adjuvant therapy. Elevated postoperative C-reactive protein (CRP) trajectories have been associated with infectious complications, whereas a timely decline in CRP may reflect a more adequate immune response. Interventions that improve nutritional status, physical fitness, and psychological resilience before surgery may modulate these inflammatory processes. The PING-P intervention combines three components starting two weeks before surgery and continuing for three weeks postoperatively: (1) structured exercise including resistance, aerobic and respiratory training supported by pulsed electromagnetic field (PEMF) therapy to both thighs twice weekly; (2) individualized nutritional therapy with counseling and provision of omega-3-enriched high-protein oral nutritional supplements twice daily to achieve ≥1.2 g/kg/day protein intake; and (3) psychological support using coaching and digital relaxation tools. The program is delivered in hospital and at home using a mobile application with regular monitoring and feedback. The primary objective is to evaluate whether this multimodal approach reduces the proportion of patients with a poor postoperative immune response, defined as either a CRP peak ≥166 mg/L or a decrease from peak CRP to two days later of \<35%. CRP will be measured from postoperative day (POD) 1 to POD7 or until discharge. Secondary objectives include assessment of feasibility (recruitment, retention, and adherence to ONS intake, PEMF sessions, and exercises), postoperative infectious and overall complications, intervention-related adverse events, functional recovery, nutritional status, body composition, and quality of life. Adults with histologically proven gastric or esophagogastric junction cancer (Siewert II-III) scheduled for minimally-invasive curative gastrectomy at National University Hospital and Ng Teng Fong General Hospital, Singapore, will be enrolled. Exclusion criteria include distant metastases, emergency surgery, need for preoperative tube or parenteral feeding, inability to follow the program, or contraindications to oral nutrition. A total of 25 participants will be recruited. The study will provide first data on whether targeted multimodal prehabilitation can favorably modify perioperative inflammation and inform the design of a future randomized trial.

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \[¹⁸F\]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancer. Following screening, using a standardized administration protocol and dose, participants will undergo \[¹⁸F\]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \[¹⁸F\]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \[¹⁸F\]FAPI-74 PET/CT.

[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of \[68Ga\]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors

This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors. SKL35502 is an imaging agent used with SPECT scans to identify tumors with neurotensin receptor 1 (NTSR1), a protein found on some cancer cells, and to assess where the agent travels in the body and the radiation dose delivered to tissues. Participants with sufficient SKL35502 tumor uptake may receive SKL35501, a treatment designed to deliver targeted alpha radiation to NTSR1-expressing tumor cells. Part A will evaluate the safety and imaging performance of SKL35502 and the safety, tolerability, pharmacokinetics, biodistribution, dosimetry, and biologically active dose range of SKL35501, as well as preliminary antitumor activity. Part B will further evaluate selected SKL35501 dose levels, including randomized low- and high-dose groups in participants with colorectal cancer, and will expand evaluation in selected tumor types. The study will also examine relationships among SKL35502 imaging, NTSR1 expression, SKL35501 tumor uptake, and treatment outcomes.

Validating a Medical AI Fine-Tuning Platform for Major Diseases

The goal of this observational study is to leverage the abundant patient resources and standardized medical records from Beijing Friendship Hospital, Xuanwu Hospital, and Beijing Anzhen Hospital, combined with the existing data and knowledge platform of guidelines, consensus, medical literature, and dialogue data from Beijing Haitian Ruisheng Science Technology Co.,Ltd, with Beijing Zhilan Medical Technology Co., Ltd. conducting the fine-tuning, optimization, and validation of the medical large language model. The model is fine-tuned according to the consultation and diagnostic needs of different departments to improve the quality and efficiency of hospital medical services, enhance intelligence, and elevate the level of medical care. Through deployment to hospitals at all levels, it aims to achieve standardized services and support graded diagnosis and treatment. The overall research includes medical big data construction, medical knowledge graph construction, medical large model training and fine-tuning, and large model application platform development and deployment.

Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer

The objective of this study is to assess two novel positron emission tomography (PET) radiotracers, \[64Cu\]CM500 and \[68Ga\]CM500, for Positron Emission Tomography-Magnetic Resonance Imaging (PET-MR) and Positron Emission Tomography / Computed Tomography (PET-CT) imaging of solid tumors. These tracers have the potential to detect solid tumors throughout the body and may enable doctors to identify smaller tumors than conventional imaging techniques.

The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies

The goal of this clinical trial is to discover the prevalence of NHPH bacteria (Non-Helicobacter pylori Helicobacter species) in patients with one of the following conditions: 1. Functional dyspepsia following the Rome IV criteria 2. Active chronic gastritis, non-H. pylori induced atrophic gastritis, intestinal metaplasia and non-H.pylori gastric dysplasia 3. Gastric cancer, including siewert type 2 and 3 esophagastric junction cancers In addition, patients undergoing bariatric surgery are included as a control group. This study will be conducted using a prospective analysis in the three targeted study populations. Biopsy specimens routinely taken during the medical procedure or via the resected material in patients belonging to the target groups will be used. Exclusion criteria: * Patients with a history of H. pylori infection diagnosed by serology, on gastric biopsy, by breath test or on antigen test in stool samples. * Pregnancy. * Underage patients (\< 18 years).

Costs of Opportunistic Upper Gastrointestinal Endoscopy and the Economic Burden of Gastric Cancer Management

Data will be extracted from routinely collected hospital databases.

Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer

Gastric Cancer is one of the leading causes of cancer-related death worldwide, and patients with unresectable locally advanced or metastatic disease have a poor prognosis. This study aims to evaluate the safety and efficacy of radiotherapy combined with CAPOX and SHR-1701, a PD-L1/TGF-β bispecific antibody, in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. By improving local tumor control and enhancing systemic antitumor activity, this study seeks to increase the opportunity for curative-intent resection and improve survival outcomes in patients with advance gastric cancer.

A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer

Gastrointestinal (GI) cancers remain a major global health burden, largely due to the lack of effective and accessible early screening strategies. Current diagnostic approaches-including endoscopy, computed tomography (CT), and magnetic resonance imaging (MRI)-are either invasive, resource-intensive, or insufficiently sensitive for detecting early-stage disease, and are therefore not suitable for population-wide screening or for simultaneously identifying multiple GI tumor types. As a result, many patients are diagnosed at advanced stages, when therapeutic options are limited and prognosis is poor. Circulating microRNAs (miRNAs) offer a promising alternative, as they are stable in peripheral blood and reflect tumor-related molecular alterations. In this study, the investigators aim to develop and validate a robust, noninvasive miRNA-based signature capable of distinguishing GI cancers from non-malignant controls. By integrating multi-cohort datasets and applying machine learning-based feature selection and predictive modeling, the investigators will construct a screening panel optimized for reproducibility, scalability, and early-stage detection. This noninvasive miRNA signature has the potential to support accessible, cost-effective, and clinically practical population-level screening for GI cancers, ultimately facilitating earlier diagnosis and improving outcomes for participants.

THE-0504 in Patients With Solid Tumors

Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.

A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors

The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab. The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab. This study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability. Part 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab. The overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy. The study will be conducted in the US, Australia, UK and in the EU.

Comparison of Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer

This study includes patients diagnosed with proximal gastric cancer (Siewert type II/III, cT1-3N0-1M0) across six tertiary hospitals, who underwent either double-tract reconstruction (DTR) or tubular gastric anastomosis (TGA). Participants were divided into two groups based on the surgical procedure. We conducted a comparative analysis of postoperative outcomes by evaluating electronic medical records, postoperative gastroscopy, 24-hour esophageal pH monitoring, and relevant rating scales.

AI-Based Risk Prediction Model for Upper Digestive Tract Cancer

Upper digestive tract cancers are often preceded by pre-malignant lesions, but there is limited evidence regarding optimal risk prediction models and screening strategies for disease progression and cancer development. This prospective multicenter cohort study aims to establish a longitudinal database integrating clinical information, endoscopic findings, pathology, genetics, epigenetics, and gastrointestinal microbiota data from subjects undergoing upper digestive tract endoscopy. The study will develop explainable artificial intelligence (AI)-based risk prediction models to identify factors associated with disease progression, treatment response, and cancer development. Participants will be followed longitudinally to evaluate changes in lesion severity and clinical outcomes.

Development and Validation of the Surgical Assessment and Healthcare (SAH) Index for Gastric Cancer Treatment Evaluation

This study develops the Surgical Assessment and Healthcare (SAH) Index, a new tool to fairly evaluate gastric cancer surgery outcomes. Gastric cancer is a serious disease that often requires major surgery, but it can be difficult to compare how well different hospitals or surgeons perform because patients have different levels of risk before surgery. The SAH Index will help solve this problem by creating a standardized way to account for patient risk factors when evaluating surgical results. The study analyzes data from 780 patients who had gastric cancer surgery in 2019, looking at factors like patient age, tumor characteristics, molecular markers, and surgical outcomes. By combining clinical information (like patient health), pathological details (like tumor type), and molecular features (like genetic markers), the SAH Index will create risk categories that allow fair comparison of surgical outcomes. This tool could help hospitals improve their care, help patients and families understand their treatment options, and help doctors make better treatment decisions. The study uses only existing medical records and does not involve any new treatments or procedures. The goal is to create a practical tool that can be used by hospitals and doctors to better evaluate and improve gastric cancer surgery outcomes.

Multimodal AI for Predicting Response to Neoadjuvant Immunotherapy in Gastric Cancer (PRISM-GC)

Gastric cancer is a major global health challenge. Currently, a combination of chemotherapy and immunotherapy (PD-1 inhibitors) is frequently used before surgery to shrink tumors, a strategy known as neoadjuvant therapy. While this approach is effective for many patients, responses vary significantly, and there are currently no reliable tools to predict which patients will benefit the most before treatment begins. The PRISM-GC study aims to develop and validate a novel Artificial Intelligence (AI) system to address this need. This is a prospective, observational study that will collect data from patients diagnosed with locally advanced gastric cancer who are scheduled to receive standard neoadjuvant chemotherapy combined with immunotherapy in a real-world clinical setting. The specific choice of immunotherapy drug is determined by the treating physician and is not dictated by the study. Researchers will analyze standard preoperative CT scans and pathological tissue slides using advanced deep learning algorithms. The goal is to create a "multimodal" AI model that can accurately predict how well a tumor will respond to treatment (specifically, whether the tumor will disappear or shrink significantly). If successful, this AI tool could help doctors personalize treatment plans in the future, ensuring that each patient receives the most effective therapy while avoiding unnecessary side effects.

Prediction of Peritoneal Dissemination of Digestive Tumors Through the Study of Circulating Tumor DNA

The peritoneum is a relatively frequent metastatic site in digestive tumors (colon, stomach, pancreas) and is characterized by a poorer prognosis compared with other metastatic sites such as the lung or liver. Its dissemination pathway is complex and most often involves crossing the hemato-peritoneal barrier. This type of metastasis is difficult to visualize on imaging at an early stage, and surgical exploration may be required. In gastric cancer in particular, exploratory laparoscopy is part of the initial staging work-up for locally advanced tumors to assess the presence or absence of peritoneal metastases. It is therefore important to develop new, less invasive detection or prediction methods. Circulating tumor DNA (ctDNA) is a promising non-invasive blood biomarker that can assist clinicians as a prognostic/predictive biomarker and/or a tool for monitoring response to anti-tumor therapies. This marker is most often assessed in plasma, but recent data suggest that tumor DNA may also be detected in other biological fluids such as peritoneal fluid. A preliminary study conducted by our team showed the ability to detect tumor DNA in peritoneal fluid from patients with peritoneal carcinomatosis of various origins, with a sensitivity of 75%. In gastric cancer, a recent meta-analysis demonstrated an increased risk of peritoneal metastases when peritoneal tumor DNA was positive (RR 13.81 \[95% CI, 8.11-23.53\]), as well as a reduction in 3-year recurrence-free survival (RR 5.37 \[95% CI, 1.39-20.74\]) and overall survival (HR 4.13 \[95% CI, 1.51-11.32\]). The objective of this cohort is to evaluate the prognostic impact of circulating tumor DNA (ctDNA) in plasma and/or peritoneal fluid on the risk of developing peritoneal metastases. The primary endpoint is: Peritoneal recurrence rate according to tumor DNA positivity status (positive vs negative).

Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer

Proximal gastric and esophagogastric junction cancers comprise up to 40% of gastric malignancies. For localized disease, proximal gastrectomy is the main radical procedure, but reconstruction of GI tract often leads to significant functional issues. Rising use of proximal resections and broader indications have increased attention to postoperative quality of life (QoL). Common reconstructions include direct esophagogastrostomy (various types), double-tract reconstruction, jejunal interposition, and newer anti-reflux anastomoses (e.g., double-flap, overlap, tunnel techniques). Each method has unique pros and cons regarding reflux esophagitis, food passage, dumping syndrome, nutritional changes, and long-term QoL. No consensus exists on the optimal technique, leading to variable practices and outcomes. Most research focuses on oncologic radicality and survival, while functional results and QoL remain understudied. Systematic evaluation of functional outcomes across reconstruction types after proximal subtotal gastrectomy is needed in Russian Federation to improve QoL, advance research, and standardize treatment of proximal gastric and EGJ cancers.

Laparoscopic Staging for Stage III Gastric Cancer

This study aims to determine, through a multicenter randomized controlled design, the impact of precision treatment guided by laparoscopic staging on overall survival (OS), surgical conversion rate, and peritoneal metastasis rate in patients with clinical stage III gastric cancer, thereby providing evidence for precision staging and treatment decision-making.