Hu He Hao Te Shi

Researchers are evaluating the safety and effectiveness of TQB3702 tablets combined with immunochemotherapy in treating B-cell lymphoma. This phase II clinical trial focuses on patients with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B cell lymphoma (DLBCL). Participants must meet diagnostic criteria according to the 2022 World Health Organization standards and have measurable disease. The treatment involves administering TQB3702 tablets, a tyrosine kinase inhibitor, together with a chemotherapy regimen designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, enhance immune function, and inhibit blood vessel formation that supports tumors. The study monitors patients throughout the treatment period to assess the combined therapy's impact on lymphoma. Participants will be closely observed during the study to evaluate their response to treatment, including overall response rate and complete response rate over a period of up to two years. Researchers will perform regular assessments of organ function, tumor measurements, and safety monitoring. Women of childbearing potential and men must agree to use contraception during the study and for six months afterward. The trial includes follow-up to ensure participant safety and treatment effectiveness over time.

Researchers are evaluating the safety and effectiveness of combining TQ05105 Tablets and TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis. This open, single-arm, multi-center clinical trial is conducted in Phase Ib/II to study this combination treatment in adults with this condition. The goal is to find the best dose and assess how well the treatment works, including measuring spleen size reduction. The study treatment includes TQ05105 Tablets, which inhibit Janus kinase 1 and 2, and TQB3617 Capsules, which inhibit Bromodomain and Extra-Terminal proteins. Participants receive these drugs together, but specific dosing schedules are not detailed in the provided information. The study includes multiple phases to evaluate safety and dose levels for up to two years. Participants will undergo various assessments, including measuring spleen volume changes and determining maximal tolerated doses. The main outcomes include the recommended phase II dose and spleen volume reduction over 24 weeks and up to two years. Safety monitoring and evaluation of symptom scores are also part of the follow-up during the study period, helping researchers understand the treatment impact and tolerability.

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 investigating the effects of a new oral synbiotic formula called SMT04 on reducing the recurrence of advanced adenomas and bacterial gene markers related to colorectal neoplasia after endoscopic removal of advanced colorectal neoplasia. This study builds on evidence linking changes in gut bacteria to colorectal cancer progression and aims to explore whether this synbiotic, combining probiotics and prebiotics, can provide longer-term benefits in preventing cancer recurrence. The trial compares the SMT04 synbiotic formula, which contains beneficial probiotic strains and heat-resistant prebiotics, against an active placebo containing vitamin C and inert substances with indistinguishable taste and appearance. Participants receive their assigned treatment following the complete removal of colorectal advanced neoplasia confirmed by histopathology. The study uses a double-blinded, randomized controlled design across multiple centers to assess outcomes over time. Participants will undergo regular assessments to monitor the return of advanced colorectal neoplasia and changes in bacterial gene markers associated with colorectal cancer risk over a one-year period. These evaluations include colonoscopies, stool tests for microbial markers, and adherence tracking. The main outcome measured is the incidence of recurrent advanced colorectal neoplasia at one year. Safety monitoring and follow-up are also part of the study to ensure participant well-being throughout the trial.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating molecular typing approaches for treating advanced thyroid cancer in this combined retrospective and prospective real-world clinical study. The study includes patients with locally advanced, recurrent, or metastatic thyroid cancer that cannot be treated with surgery and covers various thyroid cancer types such as radioiodine-refractory differentiated thyroid cancer, medullary thyroid carcinoma, poorly differentiated, and anaplastic thyroid cancer. This Phase 4 study collects detailed clinical and molecular data to assess treatment outcomes over several years. The study involves different targeted drug treatments based on specific genetic mutations found in the tumors. Patients with BRAF V600E mutation receive dabrafenib plus trametinib with or without PD-1 antibody, those with NTRK mutations are given entrectinib or larotrectinib with or without anti-PD-1 antibody, and patients with RET fusion or RET mutation receive pralsetinib or selpercatinib with or without anti-PD-1 antibody. Medullary carcinoma patients without or with unknown RET mutation may receive anlotinib or anlotinib plus anti-PD-1 antibody. Those without the above mutations or unable to afford precision treatments receive lenvatinib plus anti-PD-1 antibody. Other targeted therapies are also provided based on individual molecular profiles. The retrospective portion covers patients treated from January 2020 to December 2023, while the prospective study enrolls patients from January 2024 to April 2027. Participants provide demographic, clinical, tumor history, medication, adverse reaction, molecular testing, and survival data. Researchers track objective response rates for up to approximately three years. Data collection includes follow-ups for survival and adverse events. This comprehensive approach aims to understand treatment effectiveness and safety in a real-world setting over extended timeframes, supporting molecularly guided therapy decisions for advanced thyroid cancer.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..