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Stomach Neoplasms clinical trials

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NCT ID: NCT06437678 Not yet recruiting - Gastric Cancer Clinical Trials

Phase II Study of Liposomal Irinotecan for Advanced Refractory Gastric Cancer

Start date: May 27, 2024
Phase: Phase 2
Study type: Interventional

To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer.

NCT ID: NCT06435741 Not yet recruiting - Stomach Neoplasm Clinical Trials

Molecular Imaging of Gastric Cancer Metastatic Lymph Nodes with 99mTc-3PRGD2 Probe.

Start date: June 6, 2024
Phase: N/A
Study type: Interventional

Surgical lymph node dissection is the key to advanced gastric cancer. In recent years, after the overall implementation of standard D2 dissection, lymph node dissection for gastric cancer began to explore the direction of D1+ again. Current clinical studies of gastric cancer lymph node dissection based on intraoperative fluorescence navigation show that non-tumor specific lymph node fluorescence navigation surgery can only increase the total number of lymph nodes detected and ensure the completion of the dissection but not the accuracy. The sensitivity and specificity of the tracer metastatic lymph nodes are 56.3% (410/728), respectively. Specificity 46.1% (2669/5785). Tumor specific tracing of positive lymph nodes is the key to achieve accurate lymph node dissection for gastric cancer. Although tumor specific tracers are developing rapidly and related clinical studies are gradually being carried out, there are few reports on specific clinical studies on lymph node metastasis, suggesting that lymph node tracing is still a difficult problem. Previous basic studies have suggested that integrins play an important molecular biological role in the process of tumor lymph node metastasis. In the early stage, 99mTc3PRGD2 SPECT-CT showed good lymph node imaging effect in lung cancer and breast cancer, and 99mTc-oncoFAPI PET-CT also showed good lymph node imaging effect in gastric cancer. Therefore, this study aims to explore the application prospect of 99mTc3PRGD2 and other probes in molecular imaging of gastric cancer metastatic lymph nodes and guidance of lymph node dissection and tracer, so as to accumulate preliminary clinical data for exploring corresponding fluorescent probes for intraoperative tracer of gastric cancer lymph nodes.

NCT ID: NCT06432075 Not yet recruiting - Clinical trials for Advanced Gastric Cancer

Neoantigen Reactive T Cells c for Chinese Patients With Advanced Gastric Cancer

Start date: June 1, 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) in the treatment of Chinese patients with advanced gastric cancer.

NCT ID: NCT06429891 Not yet recruiting - Solid Tumor Clinical Trials

Research on Early Diagnosis and Clinical Transformation of Nuclide Probe Based on Bioorthogonal-gastric Cancer Mucin Target Visualization

Start date: May 2024
Phase: N/A
Study type: Interventional

The symptoms of early gastric cancer are extremely insidious and most patients are identified as advanced at the time of initial diagnosis. Starting from the clinical needs, this project selects solid tumors and pathogenic glycoprotein synthesis of key glycopeptide antigen determinant mucin (MUC) family of multiple molecules as the research object. Based on the digestive system tumor research cohort established in the early stage, this project intends to verify the tumor microenvironment characteristics of the MUC family and gastric cancer treatment resistance through immunohistochemistry, COSMC gene sequencing and other technologies, and screen key MUC family proteins. Based on the discovery of differential recognition of COSMC deficient cells by antibodies, MUC1-targeted specific monoclonal antibody was developed. Further development of spatial mucinomics based on laser ablation inductively coupled plasma mass spectrometry (LA-IPC-MS) and spatial metabolome based on desorption electrospray mass spectrometry (DESI-MS) to analyze the structure and immunosuppressive mechanism of key gastric cancer glycoprotein MUC. After obtaining key targeted antibodies, with the help of biological orthogonal and click chemistry technology, the original clinical translational research based on mucin targeting was carried out, and a high-affinity nuclide conjugate drug (RDC) with "triple binding" of gastric cancer mucin was constructed and clinical translational research was carried out, which provided new ideas for the accurate diagnosis and treatment of gastric cancer in the early stage.

NCT ID: NCT06427941 Not yet recruiting - Clinical trials for Advanced Hepatocellular Carcinoma

A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors

Start date: May 23, 2024
Phase: Phase 1
Study type: Interventional

This study is a first-in-human (FIH) Phase 1 study of BGB-B2033 to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of the BGB-B2033 in participants with advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors, non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC). The study will also identify the recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab for subsequent proof-of-concept studies. BGB-B2033 will be administered by intravenous infusion. The Phase 1 study will be conducted in 2 parts: Part A (Monotherapy Dose Escalation and Safety Expansion) and Part B (Combination Dose Escalation and Safety Expansion).

NCT ID: NCT06427798 Not yet recruiting - Pheochromocytoma Clinical Trials

Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy

Start date: June 5, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR. Objective: To test a drug ([212Pb]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells. Eligibility: Adults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery. Design: Participants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function. [212Pb]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may nee to stay in th hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of each cycle. Some participants will also get a related study drug ([203Pb]VMT-alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body. Follow-up visits will continue for 10 years....

NCT ID: NCT06427252 Not yet recruiting - Clinical trials for Gastric Cancer, Metastatic

The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of GC or EGJC With PM

Start date: May 31, 2024
Phase: Phase 2
Study type: Interventional

Gastric cancer (GC) with peritoneal metastasis has a poor prognosis and short survival. In recent years, heat intraperitoneal perfusion chemotherapy (HIPEC) has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors, including GC with peritoneal metastasis. The use of immune checkpoint inhibitors (ICIs) in the treatment of advanced GC has made significant progress in recent years. And studies showed that patients who were responded to immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection. However, whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear. Therefore, we conducted this prospective multicenter clinical trial to explore the effective dose and safety of the combination of systemic chemotherapy, HIPEC, anti-PD-1 and anti-HER-2 therapy, which will provide a clinical basis for the treatment of advanced GC.

NCT ID: NCT06426654 Not yet recruiting - Gastric Cancer Clinical Trials

Sintilimab Combined With LDRT for Neoadjuvant Treatment of Locally Advanced dMMR/MSI-H Gastric Cancer

Start date: June 10, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Recently, growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. In this study, we will explore the efficacy and safety of sintilimab and LDRT in the neoadjuvant treatment for locally advanced dMMR/MSI-H G/GEJ cancer.

NCT ID: NCT06421324 Not yet recruiting - Gastric Cancer Clinical Trials

Personalised Health Recommendations to the General Population Through an Integrated AI Guided

AIDA
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This clinical study aims to be used to implement and validate the AIDA tool in two phases: - Phase 1: Risk stratification and personalised recommendations & Model development - Phase 2: Mechanistic Model (Bioresource) development & testing

NCT ID: NCT06421220 Not yet recruiting - Gastric Cancer Clinical Trials

Evaluation of the Efficacy and Safety of Indocyanine Green Tracing in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer

Start date: May 20, 2024
Phase: N/A
Study type: Interventional

Purpose of the study To evaluate whether the clinical efficacy of submucosal injection of indocyanine green tracer laparoscopic gastric cancer lymph node dissection is superior to that of laparoscopic gastric cancer lymph node dissection without indocyanine green tracer in 3D fluorescence laparoscopic mode in patients with gastric adenocarcinoma (cT1-4a, N-/+, M0). To observe the role of submucosal injection of ICG for tumor localization in fluorescence 3D fluorescence laparoscopic surgery and the application of lymph node dissection in laparoscopic radical surgery for gastric cancer. Study design. Multicenter, randomized, open, parallel-controlled, superiority design. Subgroups Group A (experimental group): indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group Group B (control group): no indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group. Study population Patients who met all the inclusion criteria and did not fall into any of the exclusion criteria were eligible to enter this study. Randomization Patients were first evaluated preoperatively to determine that they could receive laparoscopic radical gastric cancer treatment and receive endoscopic indocyanine green labeling. Once the enrolled cases were determined to meet the admission criteria after laparoscopic exploration, they could be enrolled in this study for randomization. The central dynamic, stratified zone randomization method was used in this study, and the control factors considered were age, tumor site, and preoperative stage. Given the number of seeds and the length of the zones, SAS 9.2 programming was applied to generate the treatment allocation corresponding to the running number 484, which was deposited in the data center. A person at the participating research center was responsible for sending the enrolled case information (age, tumor site, and preoperative stage) to the randomization implementation department at the data center by email, phone, or SMS, and the contact person at each respective research center confirmed that the patient met the enrollment criteria, contacted the contact person for the assigned case in this study, and determined the enrollment of the case by further analyzing the case information, and at the same time, notified the contact person at the research center where the case was located The contact person of the research center where the case is located will be notified at the same time. Competitive enrollment was used in this study. Blinding.