Zhongshan District

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating a new preoperative method using three-dimensional CT scans and virtual resection simulation to predict lung function after surgery in patients with non-small cell lung cancer NSCLC undergoing Video-Assisted Thoracoscopic Surgery VATS. This study aims to improve accuracy over traditional methods by accounting for differences in lung ventilation caused by tumors or emphysema. It is a prospective, multi-center, longitudinal cohort study involving 60 patients split evenly between those having lobectomy and segmentectomy. Participants will undergo detailed thin-slice chest CT scans and pulmonary function tests before surgery. Using Synapse 3-D software, doctors will create patient-specific 3-D lung models to simulate the planned lung tissue removal and calculate the fraction of ventilated lung to be resected. After surgery, patients will follow standard VATS procedures. The study includes long-term follow-up with pulmonary function tests at 3, 6, and 12 months and CT scans at 6 and 12 months to observe structural lung changes. During the study, participants will have preoperative assessments, surgery, and several postoperative visits for lung function tests and imaging. Researchers will measure how closely the predicted lung function matches actual results at 3 months, as well as longer-term accuracy at 6 and 12 months. They will also study how well the remaining lung compensates after surgery and the effect of any complications on recovery. The total participation spans about one year after surgery, allowing detailed evaluation of lung function and recovery.

This research aims to compare surgical outcomes and parameters between cataract surgeries performed using a new 3D imaging system called the NGENUITY4 3D Visualization System and the current standard binocular microscope in patients with high myopia. The study focuses on how differences in depth of field between these two systems affect factors during surgery and the results, including potential complications. Participants will have high myopia and significant cataracts requiring surgery. Participants will be randomly assigned to one of two groups one group will undergo cataract surgery using the standard binocular microscope, while the other group will have surgery using the Alcon NGENUITY4 3D Visualization System. During surgery with the NGENUITY system, the surgeon wears 3D glasses and views the operation on a 3D screen. Both groups receive standard cataract extraction with phacoemulsification and intraocular lens implantation. Throughout the surgery, researchers will measure how often and how far the microscope focus is adjusted, the distance needed to focus from the corneal surface to the lens capsule, total operation time, and ultrasound energy used. After surgery, participants will be followed for three months to monitor vision, eye pressure, and any complications. These assessments will occur on day 1, week 1, month 1, and month 3 after surgery to evaluate safety and effectiveness of the two visualization methods.

Researchers are evaluating the safety, tolerability, and pharmacodynamics of 4D-310, a gene therapy, in adults with Fabry Disease who have heart involvement. This open-label, dose-escalation trial includes adult males and females aged 18 to 65 years and aims to understand how the treatment works after a single intravenous dose. Fabry Disease is a condition that affects multiple organs, including the heart, and requires new treatment approaches. Participants receive one single intravenous administration of 4D-310 at different dose levels as part of the study. The trial includes several dose groups, with some dose levels no longer enrolling. The study is conducted across multiple centers and is designed to carefully monitor responses to the gene therapy over time. During the study, participants will be regularly assessed for safety by tracking any adverse events for one year following treatment. Researchers will also monitor how the body responds to the therapy through various evaluations. The total participation time includes screening, treatment, and follow-up visits to ensure thorough observation of treatment effects and safety.

Researchers are evaluating the treatment effects of two different doses of ceftriaxone for uncomplicated gonorrhea infection in men. This phase 3 randomized controlled trial aims to determine whether a 500-mg dose is not inferior to a 1000-mg dose in treating this infection, helping to inform optimal dosing strategies. The study is sponsored by National Taiwan University Hospital and focuses on men with confirmed gonorrhea infections in various anatomical sites. Participants receive a single intramuscular injection of either 500 mg or 1000 mg ceftriaxone, both dissolved in lidocaine solution, as part of a parallel-group design. The study compares these two treatment groups over a 14-day period following enrollment to assess treatment response and other outcomes. There is no masking, and participants receive only one dose during the study. During the study, participants are monitored from enrollment through 14 days after treatment. Researchers assess treatment response, symptom duration, and any adverse events related to the treatment. Laboratory tests include measuring the minimum inhibitory concentration of ceftriaxone on bacterial isolates, genetic typing of Neisseria gonorrhoeae, and gene mutations related to drug resistance. The total participation period is about two weeks, during which safety and effectiveness are closely tracked.

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers are evaluating the effect of involving caregivers in a rehabilitation approach called caregiver-assisted rehabilitation with strategy training CAR-ST to improve daily activity functions in adults who have had a stroke. The study aims to compare CAR-ST with strategy training alone and with an education program to see which approach leads to better improvements in activity performance and whether these improvements extend to other areas like participation and impairment. This is a single-blinded, three-arm randomized controlled trial conducted in multiple centers to assess the potential benefits of caregiver involvement in home-based post-stroke rehabilitation. Participants will be randomly assigned to one of three groups CAR-ST, strategy training alone, or an education program. The CAR-ST and strategy training groups receive up to 10 therapist-guided sessions over a maximum of 6 weeks, with sessions once or twice weekly lasting about 60 minutes each. CAR-ST involves caregivers actively assisting and motivating participants during at-home practice, while the strategy training group does not include caregiver participation. The education group receives 10 matched sessions focused on stroke information delivered through face-to-face talks, video calls, or phone calls. During the study, participants will be assessed at four time points before treatment, immediately after the intervention, and at 3- and 6-month follow-ups. Researchers will use various clinical tools to measure changes in activity performance, participation, quality of life, self-efficacy, motor function, cognition, and goal attainment. Qualitative interviews will also explore participant and caregiver experiences and satisfaction. The total involvement spans from baseline through six months after treatment, with continuous monitoring and data analysis to evaluate the interventions impact.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.