Jin Hua Shi

Researchers are evaluating whether adding a traditional Chinese medicine called Lingze tablets to the standard drug tamsulosin can better improve sleep and nighttime urination problems in men after prostate surgery. This study focuses on men aged 50 years or older who have undergone transurethral holmium laser enucleation of the prostate and continue to experience bothersome nighttime urination and other urinary symptoms. It is a Phase 4 randomized, parallel-group, controlled clinical trial designed to compare the combination therapy to standard treatment alone. Participants will be randomly assigned to one of two groups: one group will take tamsulosin sustained-release capsules once daily at bedtime for 8 weeks, while the other group will take the same tamsulosin dose plus Lingze tablets (4 tablets, three times daily) for 8 weeks. Lingze tablets contain herbal extracts traditionally believed to improve urinary symptoms by supporting kidney function and clearing dampness and heat. Both groups will receive standard postoperative care instructions throughout the study. Participants will visit the clinic at baseline, 4 weeks, and 8 weeks for assessments including questionnaires on urinary symptoms, sleep quality, anxiety, and quality of life. They will also undergo non-invasive urine flow tests and report any side effects or health concerns. Medication adherence will be checked at each visit. The primary outcome is the change in nighttime urination frequency from baseline to week 8. Safety monitoring and follow-up continue throughout the 8-week treatment period, with participants encouraged to contact the study team anytime for support.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of STI-7349, a drug administered intravenously, in people with advanced solid tumors. This first-in-human, open-label Phase 1 and 2 study includes two main periods: Period I focuses on STI-7349 alone, and Period II explores STI-7349 combined with Pembrolizumab or other approved PD-1/PD-L1 inhibitors. The study aims to find the best dose and assess potential benefits in specific tumor types that may respond to these treatments. In Period I, dose escalation of STI-7349 alone occurs in two parts using a rapid titration and a traditional 3+3 design, with doses ranging from 1 mg to 6 mg in 21- or 28-day cycles. Following this, an expansion phase enrolls 20 to 30 subjects at the recommended Phase 2 dose to further evaluate safety and early effectiveness. Period II involves dose escalation and expansion of STI-7349 combined with Pembrolizumab or other PD-1/PD-L1 inhibitors, starting at half the single-agent recommended dose and increasing in sequential dose groups. The combination treatments follow similar dosing schedules and expansion sizes as Period I, continuing up to a maximum of 2 years or until specific study endpoints. Participants will undergo regular dosing on Day 1 and Day 15 of each cycle, with ongoing monitoring for treatment-related adverse events for up to 2 years. Researchers will assess safety using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) and monitor pharmacokinetics, biomarker profiles, and disease progression. Study participation includes clinical evaluations, imaging scans to measure tumor response, and frequent follow-up visits to track health status, treatment tolerance, and potential benefits.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Esophageal squamous cell carcinoma (ESCC) is a serious cancer with high rates of diagnosis at advanced stages and poor survival outcomes, especially in China. This research evaluates the combination of induction immunochemotherapy followed by concurrent chemoradiotherapy as a treatment approach for patients with inoperable ESCC. The study also focuses on using circulating tumor DNA (ctDNA) monitoring to predict treatment response and tumor progression, as ctDNA changes may occur before imaging can detect recurrence or metastasis. Participants receive induction immunochemotherapy with toripalimab combined with paclitaxel and cisplatin every three weeks for two cycles. This is followed by concurrent chemoradiotherapy involving weekly paclitaxel and cisplatin for five cycles, along with radiation treatments delivered five days per week. ctDNA testing is performed initially using tissue and blood samples and repeatedly before, during, and after treatment to track tumor DNA changes over time. During the study, patients will undergo regular ctDNA blood tests, clinical assessments, and laboratory tests to monitor treatment effects and safety. Researchers will measure progression-free survival after one year as the primary outcome. The study includes ongoing monitoring of blood markers and physical health to evaluate how well the combined treatment controls the cancer and to explore links between ctDNA results and patient prognosis. Participants are expected to be involved throughout the treatment and follow-up periods as specified.

Researchers are evaluating the anti-tumor effects of golidocitinib compared to treatments chosen by doctors in adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). This phase 3, open-label, randomized, multinational study focuses on patients who have confirmed PTCL and whose disease has returned or not responded after at least one prior systemic treatment. The study includes specific subtypes of PTCL as defined by the World Health Organization classification. Participants will receive either golidocitinib at 150 mg orally once daily in 21-day cycles or one of several investigator's choice treatments, including chidamide, pralatrexate, gemcitabine, or belinostat, each given on different schedules and doses. Golidocitinib is taken daily with or without food, while the comparator drugs are administered orally or intravenously with specific timing within 21- or 28-day cycles. During the study, participants will be monitored for progression-free survival, which is the time from randomization until disease progression or death, assessed for up to approximately four years. Researchers will evaluate treatment effects through regular assessments, including clinical exams and safety monitoring. Patients must meet specific health criteria and agree to follow contraceptive guidelines throughout the trial.

Researchers are evaluating the effects of royal jelly major proteins (MRJPs) on ovarian function and endometrial receptivity in women. These functions are key to female fertility, with ovarian reserve affecting fertility and perimenopausal symptoms, and endometrial receptivity influencing successful embryo implantation. This study aims to explore the role of MRJPs in reproductive health by assessing their impact on these functions and determining their safety and effectiveness. Participants will receive either MRJPs candy or placebo candy, both taken orally twice a day, one tablet each time, for one menstrual cycle. The MRJPs candy contains 70% freeze-dried royal jelly major protein powder, while the placebo contains whey protein powder. The candies are designed using patented technologies to ensure quality and stability. During the study, researchers will monitor participants from enrollment through the end of the one-month treatment period. They will measure anti-Müllerian hormone levels as a primary outcome to assess ovarian function. The study includes assessments of hormone levels, endometrial thickness, and gene expression related to estrogen and progesterone receptors. Safety and adherence to the treatment will also be evaluated throughout the study period.

This research aims to compare the effectiveness of two treatments, bleomycin injection and cryotherapy, for plantar warts in adults aged 18 to 65 years. The study focuses on evaluating these treatments using dermoscopy, a skin imaging technique, and investigating factors that may influence treatment outcomes. It also examines the safety, economic impact, and quality of life effects of both therapies. Participants are randomly assigned to one of two groups: the Bleomycin Group or the Cryotherapy Group. In the Bleomycin Group, a precise dose of bleomycin diluted with saline is injected directly into the wart, with the amount depending on wart size. In the Cryotherapy Group, liquid nitrogen is applied to freeze the wart twice, each freeze lasting about 10 seconds with a 30-second break. These treatments aim to clear the warts completely. During the study, researchers will monitor participants to assess the rate of complete wart clearance two weeks after treatment ends. They will use dermoscopy to evaluate the warts and collect data for analysis. Participants will be asked to consent to treatment and photography of their warts. The study includes safety monitoring and considers participants' quality of life and economic costs related to treatment throughout the trial period.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This prospective, multi-center, single-arm study will recruit about 1000 participants from approximately 50 centers across China, focusing on patients suitable for stent angioplasty. The study will last from December 2022 to December 2030, aiming to observe real-world outcomes with this stent system. Participants will receive the NOVA stent, a sirolimus-eluting device designed specifically for intracranial artery stenosis and delivered with a rapid exchangeable balloon. The study includes ten visits: preoperative screening, operation day, and follow-ups at 30 days, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. These visits will monitor the safety and performance of the stent over both the short and long term. During the study, participants will undergo assessments including digital subtraction angiography to confirm artery stenosis, and will be monitored for stroke, death, and any need for further artery procedures. Researchers will carefully track any ischemic strokes or revascularizations related to the treated artery up to one year after the operation. Follow-up visits will continue for five years to ensure thorough observation of outcomes and safety measures.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared to placebo plus CDK4/6i and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. It aims to assess treatment outcomes in the first-line setting for this specific breast cancer type. Participants will be assigned to receive either oral inavolisib once daily or a matching oral placebo once daily. All participants will also receive a CDK4/6 inhibitor on either Days 1-21 or Days 1-28 of each 28-day cycle, along with daily oral letrozole. This randomized, double-blind study will compare these two treatment combinations to monitor differences in disease progression and safety. Throughout the study, researchers will evaluate progression-free survival from the time of randomization until disease progression or death, up to 7 years. Participants will undergo assessments including tumor measurements by RECIST criteria, performance status evaluations, and monitoring of blood and organ function before treatment begins. Safety and efficacy will be closely observed during treatment, aiming to provide detailed long-term data on the study therapies.