Wei Fang 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 effectiveness and safety of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsules for perioperative treatment in patients with resectable stage II/III non-small cell lung cancer. This phase II/III clinical trial aims to study these treatments in patients eligible for curative surgery to improve outcomes. TQB2450 is a humanized monoclonal antibody targeting PD-L1, and the study focuses on how these combinations work around the time of surgery. The study divides participants into two groups. One group receives 3-4 cycles of TQB2450 with chemotherapy, followed by surgery 4-6 weeks after the last dose, then continues TQB2450 treatment for one year post-surgery. The other group receives 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsules, followed by surgery 4-6 weeks after the last dose, and then continues treatment for one year starting 4 weeks after surgery. Chemotherapy targets rapidly growing cells, while anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor. Participants will be monitored from the start of treatment up to 60 months to assess major pathologic response. Evaluations include tumor measurements using RECIST criteria and PD-L1 testing from tumor tissue. Researchers will also track safety, treatment adherence, organ function, and survival predictions. This comprehensive follow-up ensures careful observation of treatment effects and participant health throughout the study period.

Researchers are evaluating the safety, tolerability, how the body processes the drug, and early antitumor effects of BG-C137, an antibody-drug conjugate targeting FGFR2b, alone and combined with other anticancer drugs in people with advanced solid tumors. This study includes two phases: Phase 1a focuses on dose escalation and safety, while Phase 1b involves dose expansion. The trial is sponsored by BeOne Medicines, formerly BeiGene. Participants receive BG-C137 through intravenous infusion. In combination groups, anticancer agents are given either intravenously or orally. Phase 1a includes monotherapy dose escalation, safety expansion, and combination dose confirmation and safety expansion. Phase 1b focuses on dose expansion. The study will determine the maximum tolerated dose, recommended doses for expansion, and overall response rates over approximately two years. During the study, participants will undergo evaluations including safety monitoring for adverse events, pharmacokinetic and pharmacodynamic assessments, and tumor response measurements using RECIST v1.1 criteria. Researchers will collect tumor tissue samples to assess FGFR2b expression and other biomarkers. Participants' physical function, organ health, and prior treatments will be reviewed. The total study duration may last up to about two years, with close monitoring of side effects and treatment effects throughout.

Researchers are evaluating the safety, effectiveness, and plasma pharmacokinetics of 0.002% DE-117B eye drops in Chinese adults diagnosed with primary open angle glaucoma (POAG) or ocular hypertension (OHT). This Phase III study includes both a single-arm, open-label, multi-dose pharmacokinetics cohort and a randomized, evaluator-masked, active drug-controlled multicenter cohort. Participants will stop their current intraocular pressure (IOP) lowering medications before starting the study treatments. The study treatments include daily administration of 0.002% DE-117B eye drops (one drop once daily for 7 days). The study also uses 0.005% Latanoprost eye drops as an active control in the randomized portion. There is a bridging cohort and a long-term extension follow-up phase to further assess the treatments. Participants will receive their assigned eye drops and be monitored closely throughout these phases. Participants will undergo regular eye exams including IOP measurements to assess treatment effects at week 4. Visual acuity, anterior chamber angle, and corneal thickness will also be evaluated. Safety assessments will monitor for adverse events or eye conditions. The study includes washout of previous medications, detailed eligibility screening, and long-term follow-up to evaluate both efficacy and safety over time.

Bladder cancer, primarily bladder uroepithelial cancer, is a common genitourinary tumor with a high recurrence rate, especially for non-muscle-invasive bladder cancer (NMIBC), which accounts for about 75% of cases. This research evaluates how drug sensitivity testing using patient-derived bladder cancer organoids can guide individualized bladder perfusion chemotherapy to improve treatment selection and reduce recurrence. The study is designed as a multicenter cohort study and aims to compare recurrence-free survival rates among patients receiving organoid-sensitive chemotherapy, organoid-non-sensitive chemotherapy, and BCG therapy. Patients undergo organoid culture from tumor tissue collected during surgery to test sensitivity to several chemotherapeutic agents including gemcitabine, piroxicam, epirubicin, mitomycin, and doxorubicin. Based on organoid drug sensitivity results, patients are assigned to either an organoid-sensitive drug perfusion group or an organoid-non-sensitive drug perfusion group. Chemotherapy regimens include induction perfusion weekly for 4 weeks starting 4 to 8 weeks post-surgery, followed by maintenance perfusion monthly for 11 months. The BCG group receives a series of infusions over one year including induction, booster, and maintenance doses. Participants are closely followed with regular cystoscopy based on their risk level to monitor tumor recurrence and progression over one and three years. Assessments include clinical efficacy evaluations using established criteria and survival analysis to compare recurrence rates. Safety and adverse events are recorded, and data management and quality control measures are applied. The study duration includes treatment, follow-up, and outcome measurement periods up to three years to explore the value of organoid-guided therapy in precision bladder cancer treatment.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

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.

This trial studies patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. It is a randomized, double-blind, phase III clinical study designed to compare the effectiveness and safety of the drug AK112 against a placebo as a consolidation treatment. The goal is to evaluate the potential benefits of AK112 in improving outcomes for these patients. Participants receive either AK112 at a dose of 20 mg/kg or a placebo, both administered intravenously every three weeks (Q3W). The treatment is given as consolidation therapy following initial chemoradiation, aiming to maintain disease control. The study involves two groups: one receiving AK112 and the other receiving placebo, with both treatments delivered under double-blind conditions. Throughout the trial, researchers monitor participants for up to approximately six years, focusing on progression-free survival and overall survival as primary outcomes. Patients undergo regular assessments to track disease status and safety, including blinded independent center reviews. The long-term follow-up ensures comprehensive evaluation of treatment effects and participant safety over time.

Researchers are evaluating AL2846, a multi-target tyrosine kinase inhibitor, in adults with locally advanced or metastatic differentiated thyroid cancer that does not respond to radioactive iodine treatment and has progressed after prior VEGFR-targeted therapy. This phase III clinical trial aims to see if AL2846 can significantly extend the time patients live without disease progression compared to a placebo. The study focuses on patients aged 18 to under 75 years with confirmed disease progression and measurable tumors. Participants will be randomly assigned to receive either AL2846 capsules or a placebo. AL2846 works by targeting multiple receptors involved in cancer growth, including c-MET, c-KIT, VEGFR1, and RET. The study monitors treatment effects over 34 months, assessing progression-free survival. The trial is double-blinded and conducted at multiple centers to ensure reliable comparison of the drug versus placebo. During the study, participants will undergo regular evaluations including tumor measurements per RECIST 1.1 criteria, laboratory tests to monitor blood counts and organ function, and assessments of thyroid stimulating hormone levels. Safety will be closely monitored, and participants must comply with contraception requirements if of childbearing potential. The study duration and follow-up are designed to thoroughly assess how long patients remain free from disease progression while receiving the study treatment or placebo.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early antitumor effects of the drug BG-75098 alone and combined with BGB-43395 and fulvestrant in adults with advanced solid tumors. The study focuses on participants with measurable disease and good performance status, including those with tumors resistant to previous treatments or who have limited options. This is a phase 1 trial conducted in two parts to explore appropriate dosing and effectiveness. The study is divided into two phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion. BG-75098 and BGB-43395 are given orally, while fulvestrant is administered by intramuscular injection. In Phase 1a, doses of BG-75098 are increased gradually to find the maximum tolerated or administered dose, both alone and in combination with the other drugs. Phase 1b expands on this to assess the recommended doses and evaluate the treatment's impact on tumor response over up to two years. Participants will undergo regular monitoring throughout the study, including assessments of adverse events from the first dose up to 30 days after the last dose, and evaluations of tumor response by investigators. The study tracks safety and dosage levels for up to two years. Participants will receive various tests such as imaging, laboratory studies, and performance evaluations to measure treatment effects and safety. The total duration of involvement depends on the treatment phase and follow-up periods.