Ma An Shan Shi

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

Researchers are evaluating the safety and effectiveness of TQB2825 injection combined with immunochemotherapy in people with untreated or relapsedrefractory diffuse large B cell lymphoma DLBCL. This study includes both Phase 1b and Phase 2 stages and aims to measure outcomes such as the objective response rate, complete response rate, progression-free survival, duration of response, overall survival, and safety indicators like dose-limiting toxicity and maximum tolerated dose. Participants receive one of two treatment combinations TQB2825 injection plus the R-CHOP regimen which includes Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone or TQB2825 injection combined with Gemcitabine and Oxaliplatin GemOx. Each treatment cycle lasts 21 days. The study evaluates these treatments over these cycles to assess their effects on lymphoma. During the study, participants will undergo regular assessments including imaging scans, laboratory tests, and safety monitoring to track treatment response and side effects. Researchers will observe participants for up to two years to evaluate dose-limiting toxicity and maximum tolerated dose, and up to five years to assess overall survival. The study also tracks adverse events and serious adverse events throughout. Participation involves multiple visits for treatment and follow-up evaluations until study completion.

Researchers are studying the effects of managing body temperature during major cancer surgery in older patients aged 65 and above. The trial focuses on whether keeping patients at normal body temperature during surgery can reduce the chance of postoperative deliriuma condition with sudden confusion and attention problems that can worsen recovery and long-term health. The study also looks at whether temperature management can improve long-term cancer outcomes by possibly reducing cancer recurrence and related complications. Participants are randomly assigned to one of two groups. One group receives routine thermal management with warming measures activated only if body temperature drops below 35.5C during surgery. The other group undergoes targeted temperature management, involving pre-warming before anesthesia with forced-air covers and heated blankets, continuous warming during surgery, and warmed intravenous fluids to maintain a target temperature near 36.8C. Both approaches aim to keep patients warm but differ in timing and intensity of warming measures. During the study, participants are monitored for delirium occurrence within 4 days after surgery as the primary outcome. Researchers also assess thermal comfort, shivering intensity, emergence delirium shortly after surgery, and blood transfusion needs. The trial includes follow-up to evaluate progression-free survival over the long term. The study involves regular temperature monitoring and clinical assessments in the perioperative period, with total participation spanning surgery and postoperative recovery phases.

Researchers are conducting a multi-center observational study to develop and assess the accuracy of fecal multi-marker panels for screening gastrointestinal cancers, specifically gastric and colorectal cancers. The study aims to evaluate the sensitivity and specificity of stool-based biomarker testing compared to baseline endoscopic screening. This research will help determine how well these stool tests can identify gastrointestinal cancers early. Participants scheduled for gastroscopy and colonoscopy will provide a stool sample before their endoscopic procedures. These samples will undergo qualitative and quantitative Fecal Immunochemical Tests FIT along with novel biomarker testing. After the initial endoscopic screening, participants will be followed for two years to monitor outcomes and assess the screening tests performance. During the study, participants will have stool samples collected before their endoscopy appointments. Data from these tests will be compared to the results of their endoscopic examinations conducted about two weeks later. Researchers will focus on measuring the sensitivity and specificity of the fecal biomarker tests for cancer screening. The two-year follow-up will provide additional information on the tests effectiveness and participants health outcomes throughout this period.

Researchers are conducting the IDEAL study, a large, multicenter, prospective, double-blind randomized controlled trial, to evaluate the impact of an artificial intelligence AI model on diagnosing intracranial aneurysms using head CT angiography CTA. The study aims to compare the diagnostic sensitivity and specificity of this AI-assisted approach against a sham AI method, while also assessing patient prognosis and various clinical outcomes. Over 6450 patients scheduled for head CTA will be enrolled across 21 hospitals in China. Participants will be randomly assigned to one of two groups the True-AI group, where radiologists use a deep-learning AI model with high sensitivity to assist in diagnosing intracranial aneurysms, and the Sham-AI group, where radiologists use a similar AI model with very low sensitivity but comparable specificity. Both groups will undergo their usual head CTA scans and diagnoses. The study includes a 12-month follow-up to monitor repeat imaging, clinical follow-up, treatment, and patient outcomes. During the study, patients will have their head CTA images interpreted with either the True-AI or Sham-AI assistance, without knowledge of group assignment by patients or radiologists. Researchers will assess diagnostic accuracy, detection rates of intracranial lesions, workload of CTA interpretation, resource use, hospitalization rates, quality of life measures, functional outcomes, and safety indicators at 3, 6, and 12 months. The primary outcomes focus on diagnostic sensitivity and specificity at 6 months, with secondary outcomes covering broader clinical and patient-centered measures over the follow-up period.

Researchers are investigating whether local radical treatment of liver metastases combined with systemic therapy can improve outcomes in patients with colorectal cancer that has spread to multiple organs. The study aims to determine if this approach can benefit survival compared to systemic therapy alone or combined with other local interventions. It also explores risk factors affecting prognosis, assesses quality of life, and evaluates treatment safety. Participants are assigned based on their preference to one of two groups. One group receives radical local treatment of liver metastases through surgery or ablation combined with systemic therapy, which includes chemotherapy, targeted drugs, or immunotherapy. The other group receives systemic therapy alone or combined with local interventional therapies such as transcatheter arterial chemoembolization TACE or hepatic arterial infusion chemotherapy HAIC. Participants will be followed every three months for up to two years. During this time, researchers will monitor overall survival, progression-free survival focused on liver metastases, and any adverse events. Quality of life will be assessed using questionnaires. Regular evaluations will include clinical assessments and laboratory tests to ensure safety and track outcomes throughout the study period.

Researchers are evaluating the efficacy and safety of TQB2102 for injection in adults aged 18 to 75 years with HER2 negative recurrent or metastatic breast cancer. This Phase II trial focuses on patients whose cancer has returned or spread and who are not suitable for surgery or radiation aimed at cure. Participants must have measurable tumors and meet certain health standards to join the study. Participants receive TQB2102 for injection, a HER2 dual-antibody-drug conjugate, given as an intravenous infusion at a dose of 7.5 mgkg every three weeks, with each treatment cycle lasting 21 days. The study follows participants for up to 48 months to assess various outcomes including tumor response, disease control, survival, and safety. Blood samples are collected at specific treatment cycles to monitor anti-drug antibodies. During the study, participants will undergo evaluations of tumor response and progression, survival, and adverse events. Safety is monitored throughout, including tests for anti-drug antibodies and circulating tumor DNA. Female participants of childbearing potential agree to use contraception during and after the study, and all participants are monitored for organ function and disease status. Follow-up continues up to four years to fully assess treatment effects and safety.

Researchers are studying the safety and effectiveness of starting direct oral anticoagulants DOACs early versus delaying their start in adults who have had an acute ischemic stroke related to atrial fibrillation and received emergency endovascular therapy EVT. This trial is a multicenter, randomized controlled study designed to compare different timings for beginning DOAC treatment after stroke. Participants are randomly assigned to one of two groups. One group will begin taking any DOAC within 96 hours 4 days of stroke onset, while the other group will start DOAC treatment between 5 and 14 days after stroke onset. The study compares these two approaches to see which timing is safer and more effective. During the study, participants will be monitored for outcomes including recurrent ischemic stroke, symptomatic brain bleeding, and death over 90 days. Researchers will also assess other events like venous clots, heart attacks, and overall quality of life. Follow-up visits and assessments will track these health outcomes and safety measures throughout the study period, which lasts up to one year for some outcomes.

Researchers are evaluating the safety and effectiveness of starting direct oral anticoagulants DOACs early versus delayed in patients who have an acute ischemic stroke related to atrial fibrillation and develop bleeding in the brain after emergency endovascular treatment. This multicenter, open-label, randomized controlled trial focuses on the best timing to begin DOAC therapy to help manage these patients and reduce risks of complications such as recurrent stroke or bleeding. Participants will be randomly assigned to one of two groups an early anticoagulation group starting DOACs within 4 weeks of stroke onset, and a delayed anticoagulation group starting DOACs between 4 and 8 weeks after stroke onset. The study compares these two approaches to determine which timing is safer and more effective for this condition. The treatments involve any direct oral anticoagulant drug, and the trial is conducted at multiple centers with an open-label design. During the study, participants will be closely monitored for outcomes including recurrent ischemic stroke, symptomatic brain bleeding, and death over 90 days. Other assessments include measuring quality of life, hospital stay length, vascular events, and functional recovery using the modified Rankin scale. Researchers will collect data through imaging, clinical evaluations, and questionnaires. Follow-up is planned for 90 days after starting treatment to assess safety and overall health outcomes.

This research aims to observe the use of REKOVELLE4 in Chinese women undergoing assisted reproductive technologies such as in vitro fertilisation IVF or intracytoplasmic sperm injection ICSI. The study will gather information on how REKOVELLE4 is used in routine clinical practice, focusing on its effectiveness, safety, and usage patterns. About 2500 women will be enrolled across 30 to 50 sites in China. The total study duration will be approximately 35 months. This is a non-interventional, observational study where participants will receive REKOVELLE4 as prescribed by their doctors during controlled ovarian stimulation for IVF or ICSI cycles. The study does not assign treatments but monitors the natural use of REKOVELLE4 in a real-world setting. No additional treatments or interventions are planned by the study itself. Participants will be followed for up to 15 months to measure outcomes like live birth rates per initiated stimulation cycle. Additional data collected include hormone levels, cycle cancellations, number of oocytes and embryos, implantation rates, pregnancy rates at various stages, and safety information such as adverse reactions and ovarian hyperstimulation syndrome occurrences. Researchers will also track medication doses and stimulation durations. This comprehensive monitoring helps understand REKOVELLE4 use and associated outcomes in everyday clinical practice.