Cancer Therapy

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.

This research aims to evaluate the effectiveness and safety of a combination treatment using Selinexor, Pegaspargase, and Dexamethasone for patients with early-stage NK/T-cell lymphoma. The study is designed as a Phase 1 and Phase 2 clinical trial and focuses on improving local disease control and overall prognosis in this specific type of lymphoma. Patients receive an oral regimen combining Selinexor, Pegaspargase, and Dexamethasone. Selinexor works by inhibiting nuclear export proteins that are overexpressed in malignant tumor cells, including viral mRNA such as EBV. This treatment is combined with sequential radiotherapy to potentially enhance outcomes. The study monitors the responses to this combined therapy in early-stage lymphoma. Participants will be involved in regular assessments to track tumor response and overall health. The primary outcome measured is the complete response rate (CRR) based on tumor volume reduction, evaluated up to 36 months from randomization. Safety and treatment effects will be closely monitored during the trial period, which runs from September 2024 through December 2026.

Breast cancer is a leading cause of death among women worldwide and is classified into subtypes based on hormone receptor and HER2 status. This research focuses on the role of epigenetic regulators, specifically non-coding RNAs like lncRNAs UPK1A-AS1 and UNC5B-AS1, which may influence gene expression involved in breast cancer development. Studying these molecular markers aims to improve diagnosis and prognosis and enhance understanding of breast cancer biology. The study is observational and involves Egyptian female breast cancer patients newly diagnosed with malignant non-metastatic breast cancer, compared to healthy volunteers. Researchers will measure the expression levels of the candidate lncRNAs and their target microRNAs using quantitative real-time PCR in serum and tissue samples. Protein levels related to these markers will be assessed by ELISA. The study will also analyze the relationship between these markers and clinical features such as tumor stage, grade, and known prognostic biomarkers. Participants will provide blood and tissue samples for molecular analysis, and clinical data will be collected from medical records. Laboratory tests include RNA extraction, qRT-PCR, and ELISA assays. The primary outcomes include evaluating the expression and role of the lncRNAs and their targets, comparing them between patients and healthy controls, and correlating these findings with clinical characteristics. The study will last about 12 months, with careful data analysis to explore potential new markers for breast cancer diagnosis and prognosis.

This research aims to understand how patients with cancer respond to COVID-19 vaccination by studying the levels of protective antibodies over time. The focus is on individuals with solid organ malignancies receiving various anti-cancer treatments such as chemotherapy, targeted therapy, and immunotherapy, as well as those who have been disease-free for at least six months. Since cancer patients were excluded from initial vaccine trials, this study seeks to fill knowledge gaps about vaccine safety and effectiveness in this group. Participants include cancer patients who are either undergoing active treatment or are disease-free for six months or more. They are grouped based on their treatment type: chemotherapy, targeted therapy, immunotherapy, or disease-free status. The study involves monitoring antibody trends related to COVID-19 infection and vaccination at multiple time points over a 12-month period. During the study, researchers will collect blood samples to measure neutralizing and spike antibody levels every three months for up to one year. Participants will be followed to track their immune response depending on their cancer treatment and biological aging status. The study will also assess how antibody levels change over time and correlate with different treatments and patient characteristics. Safety and consent are carefully monitored throughout the trial.

This research evaluates (Z)-endoxifen as a potential treatment for premenopausal women with estrogen receptor positive (ER+) and HER2-negative breast cancer. The study is open-label and includes two parts: a pharmacokinetic (PK) part to understand how the body processes the drug, and a treatment part to assess the drug's effect on tumor growth by measuring the biomarker Ki-67. The trial is sponsored by Atossa Therapeutics, Inc. and aims to determine if (Z)-endoxifen can slow or stop tumor growth in this patient group. Participants in the PK part receive daily (Z)-endoxifen capsules at doses of 20 mg, 40 mg, or 80 mg, with some also receiving a monthly injection of goserelin, which temporarily stops estrogen production by the ovaries. The treatment part uses a combination of (Z)-endoxifen at 40 mg daily plus monthly goserelin injections. After 4 weeks, tumor tissue is sampled via biopsy to measure Ki-67 levels. If Ki-67 is 10% or less, participants may continue treatment for up to 24 weeks; if greater than 10%, they proceed to surgery earlier. Participants attend regular visits for treatment and assessments, including blood tests and breast biopsies to monitor drug levels and tumor response. The main outcomes measured include (Z)-endoxifen blood concentrations and tumor Ki-67 reduction after 4 weeks, along with tumor response after 24 weeks. Study participation lasts up to 6 months, followed by surgery and a one-month follow-up to evaluate safety and treatment effects.

Researchers are evaluating the safety and appropriate dose of increasing levels of the radioactive drug 131I-TLX101, given by intravenous infusion, combined with the best standard care in adults newly diagnosed with glioblastoma, a type of brain cancer. This open-label, single-arm study is conducted across multiple centers and aims to understand how patients tolerate this treatment alongside standard therapies. Participants receive escalating doses of 131I-TLX101 through an intravenous infusion along with the standard chemoradiation therapy known as the Stupp regimen, beginning 3 to 6 weeks after surgical removal of the tumor. The study includes a dose-finding phase to establish the recommended dose, with safety monitored throughout. The radioactive drug is administered in ascending doses, and the study observes participants for up to 62 weeks. During the study, participants will undergo regular safety assessments including laboratory tests of liver and kidney function, monitoring for adverse events, and evaluations of treatment-related toxicities for up to 62 weeks. Researchers will track the incidence and severity of dose-limiting toxicities and treatment-emergent adverse events. Participants must comply with radiation safety guidelines and attend scheduled visits for monitoring. The total study duration from screening until the end is about 62 weeks.

Researchers are evaluating the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MR) for diagnosing primary and metastatic cancer lesions, detecting recurrence, and assessing pathological response across various cancer types. The study is observational and aims to assess how well these imaging methods perform compared to standard diagnosis using histopathology and follow-up. Participants with different types of cancer undergo imaging with 18F-FAPI-04 PET/CT and PET/MR scans. The tracer 18F-FAPI-04 is injected into patients before the scans. Tumor uptake is measured by maximum standard uptake value (SUVmax) and tumor to background ratio (TBR). The imaging results are compared using sensitivity, specificity, positive predictive value, negative predictive value, and accuracy to evaluate diagnostic performance. During the study, participants are assessed through these imaging procedures to monitor tumor presence, recurrence, or response to treatment. The primary outcome is the diagnostic performance evaluated over one year. The study includes participants aged 18 to 90 years and involves informed consent and ethical approval. The total duration and follow-up details are based on imaging and clinical evaluations to confirm findings.

Researchers are evaluating the diagnostic performance of two PET tracers, 18F-FDG and 68Ga-FAPI-46, in female patients with estrogen receptor-positive (ER+) breast cancer. This pilot study focuses on patients with locally advanced, recurrent, or metastatic breast cancer and aims to determine if 68Ga-FAPI-46 detects more lesions than 18F-FDG, potentially leading to more accurate staging and treatment decisions. The study is sponsored by Maastricht University Medical Center and is conducted as a Phase 2 interventional trial. All participants will undergo an additional 68Ga-FAPI-46 PET/CT and PET/MRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PET/CT or PET/MRI scans. The study focuses on comparing these two diagnostic tracers' accuracy in detecting cancer lesions in ER+ breast cancer patients. Participants will be followed from diagnosis until both PET exams are completed. The researchers will collect data to help calculate sample size for future studies and explore the feasibility of taking biopsies from lesions identified by the new tracer. Safety and ability to complete imaging procedures will be monitored. The total participation duration covers the time needed to conduct both imaging exams and any related assessments.

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 new imaging techniques to better detect tumors in people with brain metastasis. This study focuses on comparing positron emission tomography (PET) combined with magnetic resonance imaging (MRI) against other imaging methods to determine if these newer techniques can more accurately identify cancerous tissue. Improved imaging is important to help locate tumors and guide future cancer treatments. Participants will undergo a single PET/MRI scan using a radiotracer called F-Fluciclovine, followed by a separate MRI scan with a tracer. These imaging methods are performed on the same machine that creates detailed pictures using magnets and radio waves. The PET and MRI scans assess protein levels in tumor tissue, with higher protein levels suggesting tumor presence rather than normal brain tissue. During the study visit, which lasts about three hours, participants will be asked to lie still for 30 to 60 minutes during imaging. Researchers will measure amino acid uptake into tumor tissue to compare imaging results. Patients must be able to complete the scans without requiring intravenous sedation, and medication use for mild anxiety is allowed under specific conditions. All scans and procedures are conducted to monitor tumor presence and treatment changes safely.