Luoyang

Researchers are evaluating the best technical approach and long-term tumor safety of sentinel lymph node biopsy SLNB in patients with initial cN1 breast cancer who have undergone neoadjuvant chemotherapy NAC and have downgraded to clinical axillary node-negative status ycN0. Although SLNB is recommended by guidelines, the optimal technique and long-term safety data are still unclear, prompting this real-world study to explore these aspects further. The primary focus is on axillary recurrence-free survival, alongside other important outcomes related to lymph node recurrence, disease-free survival, overall survival, lymphedema incidence, and quality of life. This prospective, multicenter, single-arm study involves patients receiving SLNB after completing NAC and before breast surgery. If the frozen pathology of sentinel lymph nodes SLNs is negative, no axillary lymph node dissection ALND is performed. If SLNs are positive or the frozen pathology is falsely negative, ALND is recommended, with completion within 12 weeks after SLNB surgery if needed. The study aims to evaluate this optimized pathway and its outcomes in a real-world clinical setting. Participants will be monitored over five years after surgery to assess axillary recurrence-free survival and secondary outcomes such as regional lymph node recurrence, disease-free survival, overall survival, and postoperative upper limb lymphedema. Quality of life will also be evaluated using the EORTC-QLQ-C30 V3 scale. The study involves regular follow-up and assessments to track these outcomes and understand the long-term safety and effectiveness of the SLNB approach in this patient group.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are evaluating a new combination treatment involving Darsilide with endocrine therapy, Trastuzumab, and Patuzumab for women with early or locally advanced hormone receptor-positive, HER2-positive breast cancer before surgery. This phase 2, single-arm, open clinical study aims to explore the effectiveness and safety of this new adjuvant therapy approach for these patients. Participants receive 150 mg of Darsilide once daily for 21 days followed by a 7-day break, forming a 28-day treatment cycle. Letrozole is given daily at 2.5 mg, with additional Trastuzumab and Patuzumab administered intravenously every three weeks or as a fixed-dose combination subcutaneous injection every three weeks. Patients undergo 8 cycles of this treatment before surgery. After two cycles, MRI scans evaluate tumor response those with partial response continue the same treatment, while others switch to a chemotherapy regimen. During the study, participants are closely monitored through breast MRI to assess tumor remission. Researchers measure the rate of complete pathological response after surgery as the primary outcome. Secondary outcomes include the occurrence of adverse events, objective tumor response rate, residual cancer burden, and survival rates up to five years after surgery. The study includes safety monitoring and follow-up as part of participant involvement throughout the treatment and evaluation periods.

Researchers are evaluating the safety and preliminary effectiveness of DB-1311 combined with BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, open-label, multicenter trial includes participants with various cancers such as hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, ovarian cancer, non-small cell lung cancer, pancreatic ductal carcinoma, breast cancer, colorectal cancer, and metastatic castration-resistant prostate cancer. The trial involves escalating doses of the drug combinations DB-1311BNT324 with either BNT327 or DB-1305BNT325. These treatments are given intravenously to define recommended phase 2 doses in different patient groups. Participants are assigned to one of several study arms based on their cancer type and dose level, with treatment continuing as per protocol. The study aims to establish safe dosing and observe treatment responses over time. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and adverse events up to 72 months. The study will measure tumor response using RECIST 1.1 criteria and evaluate overall survival, progression-free survival, and other outcomes. Blood samples will be collected to study drug concentrations and immune responses. The trial includes follow-up visits to monitor safety and effectiveness throughout the study duration.

This research aims to evaluate the effectiveness and safety of two types of breast reconstruction in women with breast cancer who need postoperative radiotherapy. It focuses on comparing immediate one-stage prepectoral prosthetic reconstruction with two-stage expanderprosthesis reconstruction in patients diagnosed with breast cancer without distant metastasis. The study will record changes in quality of life using BREAST-Q scores, as well as complications, capsular contracture, and tumor safety over time. Participants will undergo nipple-sparing or skin-sparing mastectomy followed by either immediate prepectoral implant reconstruction or two-stage reconstruction involving a tissue expander first, then permanent implant after radiotherapy. Both surgical approaches allow open, endoscopic, or robotic techniques, with or without mesh use. Radiotherapy timing differs immediate reconstruction patients receive radiotherapy after implant placement, while two-stage reconstruction patients receive radiotherapy with the expander in place before implant exchange six or more months later. Throughout the study, patients will be monitored with quality of life assessments before surgery and one year afterward using BREAST-Q scores. Secondary outcomes include breast reconstruction success rates, surgical complications, aesthetic evaluations by doctors, capsular contracture development, nipple and skin sensation, and long-term tumor safety measured by disease-free and overall survival up to five years. The study plans to enroll over 104 patients, with participation lasting at least one year for primary outcomes and longer for survival follow-up.

Colorectal cancer CRC is a leading cause of cancer-related death worldwide, with a complex development process involving genetic and environmental factors. This research aims to explore the role of brain-gut interactions, particularly neuro-metabolism, in the development and progression of CRC. The study focuses on understanding how brain networks and metabolic processes may influence tumor growth and spread, which could help identify new diagnostic and treatment strategies for CRC. The study uses advanced imaging techniques like 18F-FDG PETCT scans to examine brain metabolism and its connection to CRC. Participants diagnosed with colorectal adenocarcinoma will have their PETCT images collected and analyzed to assess the prognostic value of a neurometabolic network model called BRIDGE. This observational study compares BRIDGEs predictive ability for overall survival with traditional clinical models. Participants will undergo PETCT imaging within 1 to 2 weeks after enrollment, with images anonymized and centrally reviewed for quality. Researchers will collect clinical data and follow patients to evaluate survival outcomes. The primary measure is the area under the curve AUC for BRIDGE in predicting overall survival. The study will run from March 2024 to December 2026, aiming to provide insights into brain metabolisms role in CRC prognosis and support future tailored therapies.