Luoyang

Researchers are evaluating the best approach and long-term safety of axillary sentinel lymph node biopsy (SLNB) in patients with initial clinical node-positive breast cancer (cN1) who have responded to neoadjuvant chemotherapy (NAC) and downgraded to clinical node-negative (ycN0). Although SLNB is recommended by guidelines for these patients, the optimal technical method and long-term tumor safety data remain unclear. This real-world study aims to clarify these points, focusing on axillary recurrence-free survival as the main outcome. The study involves performing SLNB after completion of neoadjuvant therapy and before breast surgery. If the SLNB frozen pathology results are negative, no further axillary lymph node dissection (ALND) is performed. If positive, ALND is done directly. The study carefully monitors for false negatives in frozen pathology. The investigation is single-arm and multicenter, assessing an optimized technical pathway for SLNB in this patient group. Participants will be followed over time to assess axillary recurrence-free survival at 5 years post-surgery. Secondary outcomes include regional lymph node recurrence-free survival, disease-free survival, overall survival, postoperative upper limb lymphedema incidence, and quality of life. Patients will be monitored with clinical evaluations and other assessments as needed to ensure comprehensive safety and efficacy data collection throughout the study period.

Researchers are evaluating a new combination treatment for women with early or locally advanced HR positive HER2 positive breast cancer. This Phase 2, single-arm, open clinical study aims to explore the effectiveness and safety of using Darsilide alongside endocrine therapy, Trastuzumab, and Patuzumab before surgery. The study focuses on improving outcomes for patients with triple-positive breast cancer (TPBC) through this neoadjuvant approach. Participants receive 150 mg of Darsilide once daily for 21 days followed by a 7-day break, forming a 28-day treatment cycle. Letrozole 2.5 mg is taken daily by premenopausal patients receiving ovarian function suppression. Trastuzumab and Patuzumab are given intravenously every three weeks, or as a fixed-dose combination injection under the skin, with all patients completing eight treatment cycles. Breast MRI scans are performed during treatment to monitor tumor response before surgery. Throughout the study, participants undergo various assessments including clinical evaluations, imaging, and laboratory tests to monitor treatment effects and safety. The main outcome measured is the pathologic complete response rate immediately after surgery, which indicates how many patients have no signs of cancer following the neoadjuvant therapy. The entire treatment and evaluation period is closely monitored to understand the treatment’s impact.

Researchers are evaluating the safety and early effectiveness of DB-1311 combined with either BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, multicenter, open-label trial includes participants with several types of cancer, including hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, platinum-resistant ovarian cancer, and non-small cell lung cancer. The study focuses on targeted patients whose cancers have recurred, progressed, or are difficult to treat. The trial involves two treatment combinations delivered intravenously: DB-1311 with BNT327, and DB-1311 with DB-1305. Participants receive these investigational drug combinations under close observation. The study is divided into two parts: the first part evaluates dose-limiting toxicities within 21 days after the first dose, while the second part assesses treatment safety and response rates up to 72 months. This design allows researchers to monitor both short-term safety and long-term treatment effects. During the study, participants undergo regular assessments including monitoring for adverse events, tumor response evaluations using RECIST criteria, and organ function tests. The primary outcomes include the number of participants experiencing dose-limiting toxicities early in treatment and the objective response rate, which measures the proportion of participants showing significant tumor shrinkage. Safety monitoring continues throughout the study duration, with follow-up visits extending up to six years to observe long-term effects and participant health.

Researchers are evaluating the effectiveness and safety of two types of breast reconstruction surgeries in women with breast cancer who require postoperative radiotherapy. The study focuses on patients newly diagnosed with breast cancer without distant metastasis and compares immediate one-stage prepectoral implant reconstruction to two-stage expander/prosthesis reconstruction. The goal is to observe changes in quality of life and surgical outcomes, using the BREAST-Q scores before and one year after surgery as the main measure. Participants will receive either immediate one-stage prepectoral implant reconstruction or two-stage reconstruction involving a tissue expander followed by a permanent implant. Both groups will undergo postoperative adjuvant radiotherapy. The procedures may be performed using open, endoscopic, or robotic techniques, and include nipple-sparing or skin-sparing mastectomy. Lipofilling and symmetrization procedures are allowed during the study. The study is prospective and will track complications, cosmetic results, capsular contracture, sensation, and tumor safety. During the study, patients will be monitored through assessments including BREAST-Q questionnaires at baseline and 12 months post-surgery. Researchers will also record surgical success rates, complications, breast appearance evaluated by doctors, and sensation changes. Participants may be involved in other trials if approved and must adhere to study protocols. The total observation period includes preoperative and one-year postoperative follow-up to evaluate outcomes and safety.

Colorectal cancer (CRC) is a leading cause of cancer-related death worldwide, with increasing incidence and mortality rates. This research focuses on understanding how the brain-gut axis, which involves communication between the gastrointestinal system and the central nervous system, affects CRC development and progression. The study aims to explore the role of neuro-metabolism in CRC tumor growth and spread, hoping to uncover new diagnostic and treatment approaches. The study evaluates the BRIDGE model, which uses brain imaging data from PET/CT scans to predict overall survival in CRC patients. Participants will have PET/CT images collected and processed according to a standardized protocol, with anonymized data uploaded to a cloud platform for analysis. The study compares the predictive accuracy of BRIDGE against traditional clinical models to assess its usefulness in forecasting patient outcomes. During the study, participants' demographic and clinical information will be recorded, and their PET/CT images carefully reviewed for quality. The main outcome measured is the area under the curve (AUC) from March 2024 to December 2026, reflecting the model's accuracy in predicting survival. This observational study seeks to provide insights into how brain metabolism relates to CRC prognosis and to support the development of AI-assisted cancer care.