Taoyuan 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.

This research investigates alveolar ridge preservation after tooth extraction by examining different methods to support bone regeneration. It focuses on the use of autologous tooth root slices, bone graft materials, collagen plugs, and vitamin D3 to improve healing and bone formation in the extraction site. Advanced 2D and 3D imaging technologies are used to monitor bone regeneration without invasive biopsies. The study evaluates if combining these biological materials and treatments can increase bone formation rates and stabilize the wound more effectively than traditional methods. Participants are randomly assigned to one of four groups receiving different combinations of treatments bone graft with collagen plug alone bone graft, collagen plug, and local vitamin D3 bone graft, collagen plug, and autologous tooth root slices or bone graft, collagen plug, vitamin D3, and autologous tooth root slices. The autologous tooth root slices are placed over the extraction socket to seal it and help protect bone graft materials, while the skin flap is surgically raised to cover and stabilize the tooth root cover. This approach aims to reduce contamination and promote faster healing. Throughout the study, participants undergo imaging assessments including 3D computed tomography, periapical X-rays, and intraoral scans at the start and between weeks 12 to 16 after extraction. Implant stability is also measured between weeks 16 and 24. These evaluations help researchers observe bone regeneration progress and wound healing. The total participant involvement spans from initial tooth extraction through follow-up periods to assess treatment effects and implant stability.

Researchers are evaluating the effectiveness of two diagnostic imaging methods, 68Ga-PSMA PET and Bone Scan, in detecting the progression of metastatic castration-resistant prostate cancer mCRPC in men aged 40 to 85. The study aims to compare how often each imaging tool identifies cancer progression and to explore relationships between PET tumor burden and certain blood markers. This is an open-label, single-arm clinical trial sponsored by Chang Gung Memorial Hospital. Participants will receive intravenous injections of a radioactive tracer called Ga68-PSMA-11, followed by PETCT scans performed on a specialized imaging system. Each participant undergoes a baseline PETCT scan before treatment and additional scans after the third and sixth injections of 223Ra-dichloride therapy. Bone scans are also done for comparison. The imaging and diagnostic results will be analyzed to assess differences in lesion detection between the two methods. During the study, participants will have blood tests, EKGs, and biochemistry assessments before and after their first PET scan. They will be monitored for any adverse events immediately following imaging. Experienced nuclear medicine physicians will interpret all images. The main outcome measured is the change in the number of detected lesions on PET imaging at approximately 9 to 23 weeks. Participants will be observed throughout the study, which continues until August 2025.

Researchers are investigating whether Ga-68 PSMA PETMRI can improve the diagnosis of prostate cancer compared to multiparametric MRI mpMRI in men aged 40 to 85 who have not had a prostate biopsy but show signs suspicious for prostate cancer. This observational study aims to determine if PSMA PETMRI offers better positive and negative predictive values and how lesion location agreement between PET and MRI affects diagnostic accuracy. Participants will have a Ga-68 PSMA PETMRI scan and then be monitored for two years to see if prostate cancer is diagnosed. During this period, they will visit the clinic every six months for checkups and blood tests. The study evaluates imaging results alongside clinical outcomes to assess diagnostic performance. Throughout the study, participants will undergo regular clinical assessments including blood tests every six months for two years. Researchers will measure how well the imaging techniques predict cancer presence using positive and negative predictive values based on lesion findings and PI-RADS scores. The follow-up visits and imaging aim to monitor participants health and gather data on prostate cancer diagnosis over time.

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 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 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.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with other treatments can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and how well the cancer responds to these treatments. Participants will receive sacituzumab tirumotecan in different dose levels either combined with chemotherapy every two weeks in a 4-week cycle, alone every two weeks in a 4-week cycle, or combined with cisplatin and pembrolizumab in a 3-week cycle. Treatment continues until the cancer worsens or participants cannot tolerate it. Cisplatin is given up to approximately six months, and pembrolizumab is administered for up to about two years in the combination group. During the study, participants will have regular assessments to monitor safety, side effects, and how the cancer responds via imaging and clinical evaluation. Researchers will track dose-limiting toxicities, adverse events, treatment discontinuations due to side effects, and objective response rates. Additional measures include duration of response, progression-free survival, and overall survival, with monitoring lasting up to approximately 63 months.

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.