Gastric Cancer

Gastric cancer is a leading cause of cancer-related deaths in India, and surgery to remove the stomach along with nearby lymph nodes offers the best chance for survival in cases where the cancer has not spread beyond the stomach area. Researchers are studying whether removing more lymph nodes beyond the current standard (D2 lymphadenectomy) to include additional nodes (D3 lymphadenectomy) after chemotherapy provides any extra survival benefit without increasing patient risk. The study aims to clarify the best surgical approach following chemotherapy by comparing these two methods. The trial compares two surgical methods: D2 lymphadenectomy, which removes lymph nodes around the stomach and major blood vessels, and D3 lymphadenectomy, which removes additional lymph nodes near major abdominal vessels. Participants receive chemotherapy before surgery (neoadjuvant chemotherapy) and then undergo one of the two lymph node removal procedures. Experienced surgeons perform both procedures, and the study monitors if removing more lymph nodes affects survival outcomes and patient safety. Participants will be evaluated before surgery and monitored over time to measure overall survival at five years as the primary outcome, along with disease-free survival at two years. The study involves detailed assessments including imaging and pathology to confirm cancer status, and participants must have started chemotherapy prior to surgery. The trial aims to develop clear guidelines on lymph node removal extent after chemotherapy for locally advanced but operable stomach cancer, with follow-up to assess long-term outcomes and safety.

Researchers are evaluating a new PET imaging tracer called [18F]FAPI-74 to detect cancer by targeting the fibroblast-activation protein (FAP) found in cancer-associated fibroblasts. This study aims to compare [18F]FAPI-74 PET scans to the standard [18F]-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytoma/paraganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute (NCI). Participants will receive an intravenous dose of [18F]FAPI-74 before undergoing PET/CT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by [18F]FAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline [18F]FAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

Researchers are evaluating patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) to study the safety, effectiveness, and feasibility of using indocyanine green (ICG) near-infrared imaging tracing during 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer. This prospective, single-center, randomized controlled trial compares three surgical approaches to determine if the addition of ICG imaging and 3D visualization improves outcomes, focusing on disease-free survival over three years. Participants will be randomly assigned to one of three groups: Group A receives ICG near-infrared imaging with 3D plus ultra high resolution laparoscopic gastrectomy and lymph node dissection; Group B receives ICG imaging with ultra high resolution laparoscopic gastrectomy and lymph node dissection; Group C undergoes 3D laparoscopic gastrectomy with lymph node dissection without ICG. The study plans to enroll 702 patients and follow them from surgery up to three years to assess long-term outcomes. During the study, patients will undergo surgery according to their assigned group, and researchers will collect data on operation time, number and status of lymph nodes removed, postoperative recovery, complications, immune response, nutritional status, quality of life, and survival rates. Follow-up includes pathology reports shortly after surgery and regular assessments over three years to measure disease-free survival and overall health. The study will also monitor secondary outcomes related to lymph node analysis and patient recovery.

Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract (GIT) cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein (FAP) expression in tumor samples. This Phase 1/2a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PET/CT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

Researchers are studying a new type of scan called FAPI-PET/CT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PET/CT scan, where a small amount of [18F]-FAPI-74 is given intravenously about 60 minutes before a PET/CT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.

Researchers are studying a new imaging agent called [18F]FPyQCP in a Phase 1/2 trial to evaluate its safety, radiation exposure, and how well it detects several cancers: colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study involves multiple centers and aims to provide preliminary diagnostic information on these conditions using advanced imaging techniques. Participants in this study will receive an injection of [18F]FPyQCP followed by a positron emission tomography (PET)/computed tomography (CT) scan during a designated imaging visit. The study includes two groups: Cohort A focuses on radiation dosimetry up to 360 minutes post-injection, and Cohort B evaluates diagnostic performance over a follow-up period of up to 42 days. Women of childbearing potential and sexually active men must use effective contraception during the study. During the trial, participants will undergo various assessments including imaging scans, safety monitoring for adverse events from screening through 48 hours after injection, and follow-up procedures to assess diagnostic accuracy. Researchers will carefully measure radiation exposure and imaging results to determine how well [18F]FPyQCP identifies cancer presence. The study runs until January 2028, with participants monitored closely to ensure safety and gather comprehensive data.

Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts: dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11's effects alone and with pembrolizumab.

Researchers are evaluating a treatment approach for patients with gastric cancer that has spread to the peritoneum, an advanced disease stage with poor prognosis. This phase II clinical trial aims to study the effect of combining hyperthermic intraperitoneal chemotherapy (HIPEC) with systemic chemotherapy and immune checkpoint inhibitors on the rate of complete tumor removal (R0 resection). The study also examines overall survival, progression-free survival, tumor burden, and treatment side effects in these patients. The treatment involves HIPEC using oxaliplatin heated to 43°C for 60 minutes following laparoscopic surgery, combined with systemic chemotherapy (SOX regimen including oxaliplatin and S-1) and immune checkpoint inhibitor therapy with tislelizumab given every three weeks. Participants will receive this combined regimen to assess its safety and potential to improve outcomes for peritoneal metastasis from gastric cancer. Participants will undergo laparoscopic exploration to confirm eligibility, followed by treatment and regular follow-up for up to three years. Researchers will monitor tumor removal success, survival rates at 1, 2, and 3 years, progression-free survival, and adverse reactions. The study includes detailed assessments of organ function, performance status, and adverse events throughout the treatment and observation period to evaluate safety and effectiveness.

Researchers are studying a new type of treatment called CAR-T therapy for patients with advanced malignant solid tumors that test positive for carcinoembryonic antigen (CEA). This phase I clinical trial aims to evaluate the safety and tolerability of CAR-T cells in these patients and to determine the highest dose that can be safely given as well as the recommended dose for future studies. The study focuses mainly on patients with colorectal cancer who have not responded to standard treatments. The trial includes three groups of patients receiving CAR-T cells through different methods: intravenous infusion, intraperitoneal injection, and a specialized intraperitoneal infusion called FAST CAR-T. Each group undergoes a dose-escalation process with increasing levels of CAR-T cells to find the optimal dose. Before receiving CAR-T cells, participants are treated with chemotherapy to prepare their bodies for the therapy. Participants will be closely monitored for adverse events within 28 days after receiving CAR-T cells to assess safety. Researchers will also measure disease control rates, changes in tumor markers, and how the CAR-T cells behave in the body over a one-year period. Assessments include blood tests, imaging of tumors, and evaluations of organ function. The trial will continue until December 2027, with regular follow-ups to gather information on treatment effects and patient health.

This trial is a phase III, multicenter, randomized, controlled study evaluating treatments for patients with locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have experienced failure of first-line treatment. The study compares two chemotherapy drugs, Docetaxel for Injection (Albumin-bound) and Taxotere, to assess their effectiveness and safety in this patient population. Approximately 630 patients will be randomly assigned to receive either Docetaxel for Injection (Albumin-bound) or Taxotere. Both drugs will be given by intravenous infusion once every three weeks. Treatment will continue until the disease progresses. Regular visits and imaging scans will be conducted to monitor and compare the outcomes and side effects between the two treatment groups. Participants will have scheduled visits for imaging tests to assess tumor response and disease progression. Researchers will measure overall survival, tumor response rates, progression-free survival, disease control rates, duration of response, and the frequency and severity of any adverse events. Blood samples will be collected to analyze drug concentrations. The study will continue until disease progression, with ongoing monitoring to evaluate treatment effects and safety.