Clinical Research Directory

Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesophageal Junction Adenocarcinoma

Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Not only does it show abnormally elevated serum AFP levels, but it also has a stronger angiogenic ability, a higher rate of distant metastasis, and a poorer prognosis even after a upfront R0 surgery, making it a challenging problem in the field of gastric cancer treatment. Notably, patients with AFP-positive gastric cancer have a relatively low sensitivity to the traditional standard regimens. There is an urgent need to explore targeted treatment strategies to break through the efficacy bottleneck. Combination of sintilimab, bevacizumab and XELOX/SOX for initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a multi-center, single-arm phase 2 clinical trial to evaluate efficacy, tolerability and safety of perioperative sintilimab in combination with bevacizumab and XELOX/SOX in initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma.

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.

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.

QLS5132 Combination Therapy in Advanced Solid Tumors

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion. The main questions it aims to answer are: * In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion? * In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types? Participants will: * Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents. * Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.

Early Postoperative Intervention in Gastric Cancer Patients

This study was conducted by Qilu Hospital and five other renowned medical centers, aiming to evaluate the impact of early structured postoperative intervention on quality of life and prognosis in patients with gastric cancer after neoadjuvant therapy.

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.

Influence of Age on the Choice of Treatment and Prognosis in Patients With Resectable Gastric Cancer

Next-generation sequencing (NGS) and biomarkers play a key role in the diagnosis and personalized therapy of gastric cancer. These technologies provide a deep understanding of the molecular basis of the disease. NGS allows simultaneous analysis of multiple genes, identifying mutations and changes in their expression. In case of stomach cancer, this makes it possible to identify specific mutations to determine prognosis and treatment choice, study the genomic profiles of patients to find targets for targeted and immunotherapy. The use of NGS and biomarkers allows the development of individualized treatment regimens, increasing effectiveness and reducing side effects. Biomarker analysis also helps to track the progression of the disease and identify patients at high risk of relapse. The study of molecular genetic markers in tumor tissues, as well as the influence of genetic and age-related factors, is an important scientific and clinical task. Solving this problem will create a personalized approach to patient management. This work examines the influence of age on the choice of treatment tactics and prognosis in patients with resectable gastric cancer. The main focus is on the analysis of surgical, chemotherapeutic, topographic, pathomorphological, and molecular genetic correlations in various age groups.

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.

A Study of SH009 Injection in Patients With Advanced Solid Tumors.

Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors

Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer

This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.

Prolonged Extubation in Gastric Cancer With OSA

This study aims to investigate the effect of prolonged tracheal intubation removal on the incidenceof postoperative complications in patients with gastric cancer complicated with severe obstructive sleepapnea.

To Evaluate the Safety and Tolerability of Study Drug as a Third-line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer

This study aims to evaluate the safety and tolerability of JPI-547 in combination with irinotecan as a third-line and beyond therapy for recurrent or metastatic gastric cancer

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer.

Robotic vs Laparoscopic Gastrectomy for cT4a Gastric Cancer

The goal of this multicenter, randomized, phase III clinical trial is to test whether robot-assisted radical gastrectomy improves 3-year recurrence-free survival versus laparoscopy-assisted radical gastrectomy in adults aged 18-80 years with previously untreated, resectable cT4a gastric adenocarcinoma and non-bulky lymph nodes; the main questions are whether the robotic approach confers superior RFS and maintains equivalent peri-operative safety (Clavien-Dindo ≥ II complications) and better secondary oncologic outcomes, and participants will be randomized 1:1 to undergo standardized D2 resection via robotic or laparoscopic technique and followed for 5 years with scheduled recurrence, survival, and quality-of-life assessments.

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.

Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer. The main questions it aims to answer are: 1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will： 1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks. 2. Receive SOX chemotherapy (Oxaliplatin via intravenous infusion on Day 1 and S-1 orally twice daily for 14 days) every 3 weeks for up to 6 cycles. 3. Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity. 4. Undergo tumor imaging assessments (CT or MRI) every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter to monitor the disease.

SHR-1701 + Rivoceranib (± SHR-2554) in Advanced GC After First-Line Immunotherapy Failure

To investigate the efficacy of SHR-1701 combined with Rivoceranib, with or without SHR-2554, in patients with gastric or gastroesophageal junction adenocarcinoma who have progressed on or were intolerant to first-line immunotherapy-containing treatment

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.

PPG vs. ICG in Gastrointestinal Resections

This randomized controlled trial compares a novel optical technique against the standard of care for assessing tissue perfusion in gastrointestinal surgery. Participants are randomized to receive either intraoperative imaging photoplethysmography (iPPG) or indocyanine green (ICG) fluorescence imaging. In the ICG group, the fluorescence data are comprehensively analyzed in two distinct ways: (1) Qualitative Assessment: real-time visual interpretation of the angiogram flow by the operating surgeon; and (2) Quantitative Assessment: software-based analysis of fluorescence kinetics (e.g., time-to-peak, maximum intensity) to generate objective perfusion parameters. The study aims to determine the agreement between the iPPG-based evaluations and both the qualitative and quantitative dimensions of the ICG standard.

Temporal Transformation Mechanism and Intervention Strategies of Frail-related Dietary Behaviors in Older Gastric Cancer Survivors

The investigators invite participants to participate in the research project "Research on the Maintenance Mechanism and Intervention Strategies of Dietary Behavior Changes Related to Frailty in Elderly Gastric Cancer Survivors". This project is funded by the School of Nursing of Nanjing Medical University and will be carried out in the Gastroenterology Department of the General Surgery Department of the First Affiliated Hospital of Nanjing Medical University and the Affiliated Cancer Hospital of Nanjing Medical University. Participants have been invited to join this research because participants meet the inclusion criteria for the study. This informed consent form provides participants with some information to help participants decide whether to participate in this clinical study. Participants' participation in this study is voluntary. This research has been reviewed and approved by the Ethics Committee of Nanjing Medical University. If participants agree to join this study, please refer to the following instructions. Please read carefully. If participants have any questions, please raise them to the researcher in charge of this study. Research objective (Why conduct this research?) China is a country with a high incidence of gastric cancer. Its incidence and mortality rates both rank among the top five in the world, seriously endangering the health of its citizens. With the intensification of aging, the proportion of gastric cancer patients over 60 years old among all gastric cancer patients has reached as high as 75.2%, making elderly gastric cancer patients a large group. Nutrition plays a crucial role in the frailty development of elderly survivors of gastric cancer. Research process and methods (What needs to be done if participating in the research?) If participants are willing to participate in this study, participants will be surveyed at the time points of discharge and 1 month, 3 months and 6 months after the operation. During participants' hospitalization (at admission and discharge), the investigators will use the Sociodemographic and Physiological Pathological Questionnaire, the Dietary Behavior Scale, the Tilburg Frailty Scale, the Depression-Anxiety-Stress Scale, the Family Nutrition Behavior Health Action Process Scale for Postoperative Gastric Cancer Patients, the Family Care Index Evaluation Scale, the Perceived Social Support Scale, the Family Food Environment Scale, and the Policy Environment Questionnaire to investigate participants Relevant variable indicators; At 1 month, 3 months and 6 months after the operation, telephone follow-up will be conducted using the Eating Behavior Scale, Tilburg Frailty Scale, Depression-anxiety-Stress Scale, Family Nutrition Behavior Health Action Process Scale for Postoperative Gastric Cancer Patients, Family Care Index Rating Scale, Perceived Social Support Scale and Family Food Environment Scale to dynamically evaluate the scores of relevant variables. It is used for the extraction of dietary behaviors related to later frailty and the exploration of the maintenance mechanism of transformation. What are the possible benefits of participating in the research? During the longitudinal telephone follow-up, the investigators can answer some of your questions and provide health assistance to participants. Meanwhile, the research results of this study are beneficial for later dietary nutrition and frailty management. What are the possible risks of participating in the research? The above-mentioned survey poses no risk to participants' health or prognosis recovery. Do participants need to pay any relevant fees to participate in the research? There is no need to pay any related fees to participate in this study. Is personal privacy kept confidential? The data in this study may be published, but participants' personal privacy-related information will be strictly confidential. Must participants take part in the research? Participation in this research is completely voluntary. Participants can refuse to take part in the research or withdraw from it at any stage of the research process. The investigators sincerely hope that participants will contribute to scientific research. However, whether participants participate or not, the investigators will respect participants' choice and guarantee that it will not have any impact on participants' diagnosis, treatment and care. If participants decide to participate in this study, please sign this informed consent form. If participants have any questions related to participants' personal rights and interests, participants can contact the Ethics Committee of Nanjing Medical University. The contact number is 025-86869212.

The Possible Range of No.4sb Lymph Node Dissection of Locally Advanced Distal Gastric Cancer

The main purpose of this study is to evaluate the reasonable range of No.4sb lymph node dissection of locally advanced distal gastric cancer.

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.

Clinical Application of PET Imaging Targeting GPA33 in Malignant Tumors

This study is a diagnostic study. Patients and healthy volunteers with clinically suspected or confirmed colorectal cancer, gastric cancer, pancreatic cancer and other malignant tumors with high expression of GPA33 will be recruited for PET/MR or PET/CT imaging targeting a GPA33-specific probe (in the case of \[68Ga\]Ga-NOTA-GPA33 nanobody) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET imaging in patients with contraindications. General information on the subjects' vital signs, clinical data, blood routine, liver and kidney functions and other biochemical indicators and other imaging data were collected, and histopathology of biopsy or surgical specimens was used as the final diagnostic criterion.

Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)

Neoadjuvant radiotherapy plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)