Gui Lin Shi

Researchers are evaluating whether giving 2 courses of cisplatin chemotherapy along with postoperative radiotherapy is as effective as 3 courses in treating patients with high-risk head and neck squamous cell carcinoma after surgery. This phase 3 randomized trial focuses on patients with advanced stages III and IV of this cancer type who have undergone radical surgery but have high-risk factors such as extracapsular invasion or positive surgical margins. The main goal is to compare the 3-year failure-free survival rates between the two treatment approaches. Participants will be assigned to one of two groups. One group receives intensity-modulated radiotherapy totaling more than 66 Gy, given once daily five days a week, combined with cisplatin chemotherapy at 100 mgm2 through intravenous injection on days 1 and 22 2 courses. The other group receives the same radiotherapy schedule plus 3 courses of cisplatin chemotherapy on days 1, 22, and 43. Both treatments are delivered under medical supervision to assess outcomes and side effects. During the study, participants will undergo regular assessments to evaluate failure-free survival, overall survival, distant metastasis-free survival, locoregional recurrence-free survival, and quality of life over a 3-year period. Safety and treatment tolerability will also be monitored. The trial includes close follow-up visits and evaluations to measure the effects of the different chemotherapy schedules combined with radiotherapy on cancer control and patient well-being.

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

Researchers are evaluating the combination of LBL-024 with other drugs for treating patients with advanced non-small cell lung cancer NSCLC in this open-label, multicenter phase II clinical trial. The study aims to assess the efficacy and safety of LBL-024 combined with various chemotherapy drugs. It plans to enroll up to 230 participants who have advanced solid tumors and measurable lesions. The trial consists of four cohorts, each including a safety run-in period where a small group receives LBL-024 combined with different drugs such as docetaxel, bevacizumab, pemetrexed, carboplatin, and paclitaxel through intravenous infusion. After a 21-day safety observation, researchers evaluate tolerability before continuing enrollment and extension treatments. Some cohorts include maintenance treatment phases with LBL-024 alone or combined with other drugs. Participants will undergo treatment and follow-up visits to monitor response and safety. Researchers will assess outcomes including objective response rate, disease control rate, duration of response, drug concentration levels, and immunogenicity. The study involves regular laboratory tests, physical assessments, and evaluation of measurable tumor lesions. Participation lasts through the treatment and a 28-day follow-up after stopping the study drug or before new anti-tumor therapy starts.

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called RC278 for treating locally advanced unresectable or metastatic malignant solid tumors. The study aims to find the highest safe dose, the recommended dose for further testing, and to assess how well RC278 works at that dose. This trial is a combined Phase III clinical study sponsored by RemeGen Co., Ltd., focusing on patients with solid tumors who meet specific health criteria. The study includes several stages starting with five groups receiving increasing doses of RC278 to identify the maximum tolerated dose or maximum administered dose. Following this dose-escalation, selected doses will be further tested in a randomized manner to determine the recommended Phase II dose. In the expansion phase, this dose will be studied in different types of cancers to further evaluate safety and effectiveness. RC278 is given intravenously every three weeks, and treatment continues until unacceptable side effects occur, the disease progresses, or the participant withdraws. Participants will be monitored for up to 24 months to track dose-limiting toxicities, adverse events, and tumor response using standard criteria. Assessments include imaging to measure tumor size, safety evaluations, and pharmacokinetic testing. The study collects data on how well participants tolerate the drug and how their tumors respond. Follow-up continues throughout the study to ensure participant safety and to gather comprehensive information on the drugs effects.

Researchers are conducting a multi-center clinical study to assess artificial intelligence AI algorithms for measuring heart function and size using echocardiography. The study aims to compare AI measurements with those of physicians at different experience levels, evaluate the accuracy and stability of AI, and explore its use in complex heart conditions like cardiomyopathy, valve disease, and coronary heart disease. The goal is to improve diagnostic consistency and clinical workflows across medical centers. The study involves measuring cardiac chamber size and function in 1600 participants using AI, senior physicians, and intermediate physicians. All measurements are made with Mindray ultrasonic machines. AI and intermediate physician results are completed within one day after data collection, while senior physician results are completed within one month. The study will establish a standardized reference system for AI-assisted echocardiographic measurements and evaluate AIs performance in special cases. Participants will undergo echocardiographic scans with measurements of left and right ventricular size and function, Doppler ultrasound indicators, and valve annulus displacements. Researchers will analyze data to compare AI and physician measurements, assess measurement deviations, and evaluate AIs efficiency in reducing analysis time. The study will run until July 2026, with ongoing data collection and analysis across multiple centers, aiming to promote wider clinical application of AI technology for cardiovascular disease diagnosis.

Researchers are evaluating the preliminary safety and effectiveness of AL8326 tablets combined with Toripalimab in patients who have advanced recurrent or metastatic solid tumors. This open, non-randomized phase IIIa trial aims to find the recommended phase II dose and assess objective remission rates among these patients who have limited treatment options or have experienced progression after standard therapies. The study has two parts Phase 1 involves sequential cohorts receiving AL8326 plus Toripalimab 240 mg in 28-day cycles, with dose escalation based on tolerance. Phase 2a continues treatment with AL8326 administered orally daily at the recommended dose alongside Toripalimab 240 mg given in 21-day cycles. Treatment cycles continue for up to 24 months or until disease progression or unacceptable toxicity. Participants will undergo regular assessments including tumor response evaluations every 2 to 4 cycles depending on the phase, along with safety monitoring and laboratory tests. Outcomes measured include remission rates, duration of remission, disease control, progression-free survival, and overall survival. The study requires participants to comply with follow-up procedures and safety evaluations throughout the treatment and observation periods.

Researchers are studying the effectiveness and safety of combining RC108 with Furmonertinib compared to Furmonertinib alone for treating patients with a specific type of advanced or recurrent non-small cell lung cancer NSCLC that has both EGFR mutations and MET positivity. This phase II clinical trial aims to better understand how these treatments work together for this condition. The trial involves two groups one receiving RC108 combined with Furmonertinib, and the other receiving Furmonertinib alone. Participants have unresectable locally advanced or recurrent metastatic NSCLC with certain EGFR mutations and MET positivity. Treatment and monitoring occur over several months, with careful evaluation of drug effects and safety. Participants will undergo tests for tumor response, survival rates, and disease control over a period of up to 45 months. Researchers will collect tissue samples, monitor side effects, and assess drug levels and immune responses. The study includes regular check-ins to measure how well the cancer responds and to track any adverse events or reactions.

Researchers are evaluating the real-world effectiveness of Repatha combined with standard of care SOC compared to SOC alone in Chinese adults with established atherosclerotic cardiovascular disease ASCVD. The study focuses on the risk of major cardiovascular events such as cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. This observational study aims to understand how these treatments work when used according to local clinical practice. Participants are divided into two groups based on treatment decisions made independently of the study enrollment those receiving Repatha with SOC and those receiving SOC alone. The study observes these participants over a period of up to 72 months to assess outcomes. Treatment choices follow local guidelines and approved labels, ensuring minimal impact on routine care. During the study, participants undergo regular monitoring for cardiovascular events and changes in cholesterol levels, including low-density lipoprotein cholesterol LDL-C. Researchers also track adverse events and reactions throughout the follow-up period. Participants remain under usual care, and data collection occurs alongside routine clinical visits, with a total participation time of up to six years.

Researchers are evaluating AL2846, a multi-target tyrosine kinase inhibitor, in adults with locally advanced or metastatic differentiated thyroid cancer that no longer responds to iodine treatment and has progressed after previous VEGFR-targeted therapies. This Phase III trial aims to see if AL2846 can extend the time patients live without their cancer worsening compared with a placebo. The study is led by Chia Tai Tianqing Pharmaceutical Group and involves random assignment to treatment groups with both patients and investigators unaware of the assignments. Participants will receive either AL2846 capsules or a placebo in 28-day treatment cycles. The AL2846 drug targets specific receptors involved in tumor growth, including c-MET, c-KIT, VEGFR1, and RET. The study will last up to 34 months, during which patients will be monitored for disease progression, response rates, survival, and safety. Both groups follow the same cycle length to compare outcomes fairly. Throughout the trial, participants will undergo regular assessments including imaging scans to measure tumor size, blood tests to monitor health status and safety, and evaluations by an independent review committee and researchers. Researchers will track progression-free survival as the main outcome, along with overall survival, response rates, and duration of response. Safety of AL2846 compared to placebo will also be closely monitored. Participants involvement may last up to nearly three years, allowing for detailed observation of treatment effects and tolerability.