Jin Zhou Shi

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 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.

This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of TST001, a Claudin18.2 monoclonal antibody, in adults with locally advanced or metastatic solid tumors. This open-label, multi-center Phase I/IIa trial includes patients with various cancers, including gastric, gastroesophageal junction (G/GEJ), biliary tract cancers, and others. The study aims to find the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and observe any dose-limiting toxicities (DLTs) of TST001 alone or combined with other therapies. The study has two parts: Part I involves dose escalation and expansion of TST001 as a monotherapy using two dosing schedules—once every 2 weeks (Q2W) and once every 3 weeks (Q3W). After determining MTD and RP2D, expansion cohorts with about 20-40 patients each will be treated, focusing on those with positive CLDN18.2 tumor expression. Part II evaluates dose escalation and expansion of TST001 combined with other drugs such as CAPOX, paclitaxel, gemcitabine, cisplatin, and nivolumab in specific cancer cohorts. Approximately 320 to 540 subjects will be treated overall. Participants will undergo safety monitoring through adverse event reporting up to 30 or 90 days after the last dose. Laboratory tests, tumor assessments per RECIST v1.1, and pharmacokinetic evaluations will be performed. The study tracks frequency and severity of adverse events, maximum tolerated dose, dose-limiting toxicities, and tolerability of TST001 alone or in combination. Participants must comply with study procedures and follow-up visits during the trial period.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the combination of anlotinib hydrochloride capsules and penpulimab injection as adjuvant therapy for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after radical surgery or ablation. This phase 3, randomized, double-blind, placebo-controlled study aims to compare this combination treatment against a placebo to assess its effect on recurrence-free survival (RFS). Participants will receive either anlotinib hydrochloride capsules combined with penpulimab injection or matching placebos. The study focuses on patients who have undergone radical excision or ablation (radio frequency or microwave) within 4 to 12 weeks before randomization and have high risk factors for recurrence. The investigational drugs target multiple pathways: anlotinib hydrochloride as a multitargeted receptor tyrosine kinase inhibitor and penpulimab as an antibody targeting PD-1. Throughout the study, participants will be monitored for recurrence-free survival up to 3 years from baseline. Eligibility assessments ensure participants have no extrahepatic metastasis or vascular invasion and have recovered from surgery or ablation. The study includes careful tracking of disease status and safety, with follow-up visits to evaluate the treatment's impact on preventing cancer recurrence over time.

Researchers are evaluating trastuzumab deruxtecan (T-DXd) in Chinese patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific HER2 mutations. Although T-DXd is an approved therapy in China and has shown effectiveness and manageable safety in clinical trials for NSCLC patients with HER2 mutations, there is limited real-world data on its use in this population. This prospective study aims to assess how well T-DXd works and how safe it is for these patients in a routine medical setting. This is a non-interventional, observational study where no drugs will be provided or administered by the study team. Participants who are already receiving T-DXd, either newly started or within two months before joining the study, will be enrolled. The study will observe patients receiving T-DXd as a second-line or later treatment according to their physicians' decisions without altering their care. Participants will be followed for up to approximately two years to monitor progression-free survival based on investigator assessments. Throughout the study, researchers will collect data on treatment effectiveness, overall survival, and safety. Real-world monitoring will include evaluations of tolerability and any side effects experienced. The study captures patient outcomes as they naturally occur during ongoing medical care.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are studying Huaier granules to see if they can help prevent the return or spread of colorectal cancer in patients who have had radical surgery. This open-label, multisite, prospective study focuses on patients with stage IIB, IIC, or III colorectal cancer as confirmed by postoperative histopathology. The goal is to evaluate both the effectiveness and safety of Huaier granules in this setting. Participants in this study include adults aged 18 to 75 who have undergone radical surgery within the last two months and meet specific health criteria. There is no placebo or comparator group mentioned, and the treatment involves using Huaier granules following surgery. The study observes patients after surgery while they take the granules to monitor their health outcomes related to cancer recurrence and metastasis. Throughout the study, researchers will track several important outcomes over 36 months, including disease-free survival, overall survival, local recurrence-free survival rate, and distant metastasis-free survival rate. Participants will be monitored for safety and efficacy during this period, with data collected to assess how well Huaier granules help prevent cancer from coming back or spreading after surgery.