Gui Lin Shi

Researchers are studying high-risk head and neck squamous cell carcinoma to see if using two courses of cisplatin chemotherapy alongside radiation after surgery can provide similar benefits compared to the standard three courses. This Phase 3 trial focuses on the 3-year failure-free survival rate to determine if the shorter treatment is not significantly less effective. The study also examines the effectiveness and side effects of two courses of cisplatin chemotherapy given during radiation therapy after surgery. Participants receive cisplatin chemotherapy at a dose of 100 mg/m2 by intravenous injection every three weeks, specifically on days 1 and 22, combined with intensity-modulated radiation therapy. This is compared to the standard approach of three courses given on days 1, 22, and 43. The trial is randomized and multicenter, aiming to evaluate whether fewer chemotherapy courses can maintain treatment success while potentially reducing toxicity. During the study, participants will be monitored for treatment outcomes including failure-free survival over three years. Researchers will assess treatment efficacy and toxicity, with regular medical evaluations to monitor liver, kidney, and bone marrow function. Patients must provide informed consent and meet strict eligibility requirements, including good physical function and no distant cancer spread. The study helps understand if a shorter chemotherapy regimen is a viable option for this patient group.

Researchers are evaluating the efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are evaluating the safety and effectiveness of LBL-024 combined with other drugs in treating patients with advanced non-small cell lung cancer (NSCLC), a type of advanced solid tumor. This open-label, multicenter, phase II study includes four different patient groups to assess this combination therapy. The goal is to understand how well these treatments work together and their safety in this patient population. The study involves a safety run-in period for each group, where a small number of patients receive the LBL-024 combination to monitor tolerability over 21 days. Depending on the safety results, some groups will continue treatment with LBL-024 combined with other drugs such as pemetrexed, or LBL-024 alone for maintenance therapy. Patients are randomized into different arms to receive various combinations of intravenous infusions including LBL-024, docetaxel, bevacizumab, pemetrexed disodium, paclitaxel, and carboplatin. Participants will be closely monitored throughout the study for tumor response using established criteria and safety assessments. Researchers will track the objective response rate from the time patients consent through 28 days after stopping the study drug or before starting new anti-tumor treatment. The study will enroll up to 230 subjects aged 18 to 75 years and includes regular evaluations, laboratory tests, and follow-ups to ensure safety and measure treatment effects.

Researchers are evaluating the safety, tolerability, and effectiveness of RC278 in treating patients with locally advanced unresectable or metastatic malignant solid tumors. This Phase I/II clinical trial aims to find the maximum tolerated dose and recommended dose for Phase 2, while also assessing side effects and tumor response. Participants will receive RC278 through intravenous infusion every three weeks. Treatment will continue until unacceptable side effects occur, the disease progresses, or the participant withdraws. The study includes a dose escalation period to determine optimal dosing and an evaluation period to monitor effects at the recommended dose. Throughout the 24-month study, participants will undergo regular monitoring for dose-limiting toxicities, adverse events, and effectiveness of treatment using imaging and clinical assessments following RECIST v1.1 criteria. Safety and response rates will be closely tracked to inform future research and treatment strategies.

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 evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are evaluating the effectiveness and safety of combining RC108 with Furmonertinib compared to using Furmonertinib alone for first-line treatment in adults aged 18 to 75 years with EGFR-mutated, MET-positive, unresectable locally advanced or recurrent metastatic non-small cell lung cancer (NSCLC). This Phase II trial aims to provide new options for patients whose cancer cannot be removed by surgery or treated with radiation. The study also looks at how the body processes RC108 and whether the immune system reacts to it when given with Furmonertinib. Participants will be randomly assigned to receive either the combination of RC108 and Furmonertinib or Furmonertinib alone. Treatments are taken as medications, and the study monitors patients over time to compare their responses. The study includes patients who have not received previous systemic therapy for their advanced or recurrent disease. Tumor tissue samples are collected for testing, and participants must have measurable cancer lesions. During the study, participants will undergo regular assessments including physical exams, performance status evaluation, and tumor measurements according to RECIST criteria. Researchers will track the objective response rate over 24 months to determine how well the treatments work. Safety will be closely monitored along with patient survival and overall health. Participants are expected to use effective contraception if of childbearing potential and will be followed for treatment effects and side effects throughout the study period.

Researchers are evaluating the real-world effectiveness of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.

Researchers are conducting a phase 3 clinical trial to evaluate the safety and effectiveness of Hemay005 tablets in patients with Behçet's Disease. The study is randomized, double-blind, placebo-controlled, and takes place at multiple centers. It aims to compare two doses of Hemay005 tablets with a placebo over several phases to assess improvements in oral ulcers associated with the disease. Participants will be randomly assigned to receive either Hemay005 tablets at 45 mg twice daily, 60 mg twice daily, or a placebo for a core treatment period of 12 weeks. Initially, the doses are gradually increased over the first 7 days. After this core period, all patients enter a 40-week extension phase where those originally on placebo are re-randomized to receive one of the two Hemay005 doses, including a similar dose escalation in the first week. Following the treatment phases, there is a 4-week observation period after stopping the drug. During the study, participants undergo screening for up to 8 weeks before starting treatment. Throughout the study, researchers monitor oral ulcer improvement at week 12 as the primary outcome. Participants also have regular assessments including clinical evaluations and safety monitoring. Women of childbearing potential and men not surgically sterile must use effective contraception throughout the study and for 3 months after the last dose. The total study duration includes screening, treatment, extension, and follow-up phases.