Shan Tou Shi

Researchers are evaluating the effects of reduced-dose radiotherapy (40.2Gy) compared to conventional-dose radiotherapy (49.2Gy) on low-risk target volumes in patients with chemosensitive intermediate-stage nasopharyngeal carcinoma. This phase 3 trial includes patients who have responded well to induction chemotherapy and whose plasma EBV-DNA levels have dropped to zero or below detection limits. The goal is to see if lowering the radiation dose can maintain treatment effectiveness while reducing side effects and improving quality of life. Participants will be randomly assigned to receive either reduced-dose or conventional-dose radiotherapy targeting the CTV2 area, while both groups receive the full course of PD-1 monoclonal antibody immunotherapy. The immunotherapy consists of 12 courses given every three weeks, starting with induction chemotherapy and continuing through radiotherapy and post-radiotherapy maintenance. Induction chemotherapy includes three cycles of gemcitabine and cisplatin or alternative drugs, administered intravenously. Throughout the study, patients will be closely monitored for progression-free survival and the occurrence of significant adverse events over three years. Researchers will assess survival outcomes, side effects, and quality of life differences between the two groups. Regular evaluations include imaging, laboratory tests, and clinical assessments to ensure patient safety and treatment effectiveness during the entire follow-up period.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are evaluating the safety and effectiveness of SPH5030 tablets in patients with Her2-positive or mutated biliary tract or colorectal cancer. This Phase II clinical trial focuses on people with metastatic or advanced forms of these cancers who meet specific health criteria and have not previously received certain targeted therapies. Participants will receive SPH5030 tablets orally once daily at a dose of 600 mg. The study is designed as a single-arm, open-label trial conducted at multiple centers. Treatment continues as per protocol, with patients monitored for response and safety throughout the study period. During the trial, participants will be regularly assessed for their response to treatment, including the objective response rate over approximately two years. Researchers will monitor safety, side effects, and overall health through clinical evaluations and laboratory tests. The study includes ongoing observation to evaluate the drug's impact and patient well-being during and after treatment.

Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.

Researchers are evaluating the effectiveness and safety of TQB2102 injection compared to a combination of docetaxel, trastuzumab, and pertuzumab in treating adults with HER2 positive recurrent or metastatic breast cancer. This Phase III, randomized, open-label, multicenter trial aims to compare these treatments in patients who have not received systemic anti-tumor therapy during their recurrence or metastasis stage, except for limited first-line endocrine therapy. Participants must have HER2 positive invasive breast cancer confirmed by pathology and measurable lesions. Participants are randomly assigned to one of two treatment groups in equal numbers. One group receives TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab as a positive control. The study monitors the patients during treatment and collects data on tumor response and progression. During the study, participants undergo regular assessments including imaging to measure tumor size and progression according to RECIST 1.1 criteria. Researchers track the objective response rate and progression-free survival for up to approximately 30 months. Safety and adverse events are monitored throughout the trial, and participants must have good compliance and major organ function to continue. The study includes long-term follow-up to assess treatment outcomes and tolerability.

Researchers are evaluating a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) that has a specific EGFR mutation. These patients have not cleared circulating tumor DNA (ctDNA) after initial treatment with osimertinib alone, which is linked to poorer progression-free survival. This phase II study aims to explore the safety and effectiveness of combining osimertinib with sacituzumab tirumotecan in patients who still have positive ctDNA after starting osimertinib treatment. The study includes two groups based on ctDNA test results after one 3-week cycle of osimertinib monotherapy. Patients with positive ctDNA enter Cohort 1 and receive intravenous sacituzumab tirumotecan every two weeks plus daily oral osimertinib at standard doses until disease progression or other stopping criteria. Those with negative ctDNA continue osimertinib alone in an observational Cohort 2 with treatment choices made by their doctors. Participants will undergo tumor assessments and ctDNA tests to guide group assignment. Researchers will monitor disease progression, survival without progression, side effects, and overall safety. The main outcome is progression-free survival, tracked for up to 36 months from start of combination treatment. Participants are expected to comply with scheduled visits and procedures throughout the study duration.

This research aims to verify the accuracy, stability, and clinical usefulness of artificial intelligence (AI) algorithms for measuring heart function through echocardiography. The study involves collaboration with multiple medical centers and focuses on comparing AI measurements with those done manually by physicians of different experience levels. It also explores whether AI can reduce the time needed for echocardiogram analysis and improve clinical workflows, while assessing AI's performance in complex heart conditions such as cardiomyopathy and valve disease. The study collects echocardiographic data using Mindray ultrasonic machines, with AI and physicians at each center measuring key heart parameters including left and right ventricular size and function. AI and intermediate doctors complete measurements within one day of data collection, while senior physicians at the main research unit finalize their assessments within one month. The goal is to establish a standardized reference system for AI in ultrasound measurement and promote its use across various medical institutions. Participants aged 18 to 80 years with specific heart conditions or normal hearts are involved. Researchers measure heart chamber sizes and functions through echocardiography, comparing AI and physician results for consistency and accuracy. The study also monitors how AI-assisted measurements could optimize diagnosis time and medical resource use. The total duration of participant involvement depends on data collection and measurement timelines, with ongoing analysis to support AI's clinical application in cardiovascular care.

Researchers are evaluating the safety and early effectiveness of AL8326 tablets combined with Toripalimab in patients with advanced recurrent or metastatic solid tumors. This open, non-randomized Phase I/IIa clinical trial focuses on patients who have failed standard therapies or for whom no effective treatment is available, including those receiving Toripalimab as a second-line or later treatment. The study aims to determine the recommended dose and assess tumor response over time. Participants will receive AL8326 tablets orally once daily at a dose of 10 mg per tablet, alongside Toripalimab administered by injection every 21 days at 240 mg per cycle. The trial includes a Phase I portion to identify the recommended dose after the first 28-day cycle, followed by a Phase IIa segment that monitors objective remission rates every 2 to 4 cycles, continuing for up to 24 months. Treatment schedules and dosages are carefully managed to evaluate combined therapy effects. During the study, participants will undergo regular medical assessments, including tumor measurements using RECIST 1.1 criteria and safety evaluations such as blood tests, heart function tests, and monitoring of side effects. Researchers will track the participants' response to treatment, life expectancy, organ function, and overall health status. Follow-up procedures ensure safety and effectiveness are continually monitored throughout the treatment period and beyond.

Researchers are studying the use of hyperbaric oxygen therapy in combination with standard neoadjuvant treatment for women with breast cancer. This phase II trial aims to evaluate how effective and safe hyperbaric oxygen is when added to pre-surgery chemotherapy. The focus is on patients with locally advanced or certain operable breast cancers, excluding specific types like inflammatory breast cancer or eczema-like carcinoma. Participants receive hyperbaric oxygen treatments during their chemotherapy cycles, with at least five sessions per cycle. Each session involves breathing 100% oxygen at a pressure of 2.0 ATA for 60 to 90 minutes, totaling 30 to 40 treatments overall. This device-based intervention is provided alongside the standard neoadjuvant therapy before surgery. During the study, researchers will monitor participants through assessments including clinical evaluations and safety checks. The main outcome measured is the pathological complete response rate after finishing the neoadjuvant therapy combined with hyperbaric oxygen, tracked for about six months. Safety and treatment effects will be carefully observed throughout the study period.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.