Ma An Shan Shi

Researchers are evaluating the safety and effectiveness of TQB2825 injection combined with immunochemotherapy in adults aged 18 to under 80 years with untreated or relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This phase Ib/II clinical trial aims to measure treatment responses such as objective response rate, complete response rate, progression-free survival, duration of response, and overall survival. Safety outcomes include dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose. The study involves two treatment combinations: TQB2825 injection with the R-CHOP regimen and TQB2825 injection with GemOx. The R-CHOP regimen includes rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone. TQB2825 is a bispecific antibody that targets CD20 on tumor cells and CD3 on T cells. Participants receive these treatments according to their disease status, with untreated patients receiving TQB2825 plus R-CHOP, and relapsed or refractory patients receiving TQB2825 plus GemOx. During the study, participants undergo evaluations including imaging scans to measure tumor lesions, laboratory tests, and monitoring for adverse effects. Researchers track treatment safety and effectiveness from baseline for up to two years, focusing on toxicity and maximum tolerated dose. Women of childbearing potential and men must use effective contraception during and for 12 months after the study. Participant involvement includes regular assessments to monitor disease status and treatment safety throughout the study period.

Researchers are investigating whether managing body temperature during surgery can reduce the risk of delirium and improve long-term survival in older adults undergoing major cancer surgery. Intraoperative hypothermia, or lowered body temperature during surgery, is common and linked to complications such as postoperative delirium, immune suppression, and potentially increased cancer recurrence. This study focuses on patients aged 65 and older undergoing major cancer operations lasting two or more hours under general anesthesia. The study compares two approaches to temperature management during surgery. One group receives routine care where warming devices are only used if body temperature drops below 35.56C. The other group gets targeted temperature management, including pre-warming with forced-air covers and heated blankets before anesthesia and active warming throughout surgery to maintain a temperature near 36.86C. Intravenous fluids are warmed, and multiple warming devices may be used to keep patients comfortably warm. Participants will be monitored for delirium during the first four days after surgery and for progression-free survival up to three years following surgery. Researchers will assess thermal comfort, shivering, emergence delirium, and blood transfusion rates. The study includes regular temperature checks, cognitive assessments, and long-term follow-up to gather data on recovery quality, complications, and cancer outcomes.

Researchers are conducting a large study called the IDEAL study to evaluate the use of an artificial intelligence (AI) model in detecting intracranial aneurysms using head CT angiography (CTA) scans. The study will enroll over 6450 adult patients scheduled for head CTA across 21 hospitals in more than 10 provinces in China. The main goal is to compare how well the AI-assisted diagnosis detects aneurysms compared to a control group, focusing on sensitivity and specificity. The study will also examine patient prognosis and outcomes related to aneurysm detection and treatment. Participants will be randomly assigned to one of two groups: the True-AI group using a deep-learning AI model with high sensitivity and specificity for aneurysm detection, or the Sham-AI group which uses a similar system but with very low sensitivity and comparable specificity. Neither patients nor radiologists will know which group they are in. The study includes follow-up procedures such as repeat imaging at 12 months and tracks clinical outcomes, hospitalizations, treatments, and quality of life. Cost-effectiveness and workload impact of the AI system will also be evaluated. During the study, patients will undergo head CTA scans as part of routine clinical care. Researchers will collect and analyze diagnostic accuracy data, resource use, and clinical follow-up information. They will monitor aneurysm-related events, repeat imaging results, and patient quality of life. The study aims to assess both short- and long-term effects of integrating AI into routine aneurysm diagnosis, with a total monitoring period of at least 12 months post-imaging.

Researchers are studying patients with colorectal cancer that has spread to the liver and other organs to understand if local radical treatment of liver metastases combined with systemic therapy can improve survival and affect prognosis. This study also aims to identify risk factors related to patient outcomes and assess quality of life and treatment safety. It is a prospective, multicenter, non-randomized controlled study focusing on patients with resectable liver and controllable extrahepatic metastases. Participants are assigned to one of two groups based on their willingness. Group I will receive radical local treatment of liver metastases, such as hepatectomy or ablation, combined with systemic therapies including chemotherapy, targeted drugs, or immunotherapy. Group II will receive systemic therapy alone or systemic therapy combined with local interventions like transcatheter arterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). The treatments and follow-up evaluations occur over a period of up to two years, with follow-up visits every three months. During the study, participants will undergo regular assessments including imaging to confirm metastases, laboratory tests to monitor health status, and questionnaires to evaluate quality of life. Researchers will track overall survival from study inclusion up to two years or until death. Safety and treatment effectiveness will be monitored throughout, along with identifying factors that may influence patient prognosis. The study includes patients aged 18 to 80 years with good performance status and controlled extrahepatic disease.

Researchers are evaluating the effectiveness and safety of TQB2102 for injection, a HER2 dual-antibody-drug conjugate, in patients with HER2 negative recurrent or metastatic breast cancer. This Phase II clinical trial focuses on individuals whose cancer has returned or spread and who are not suitable for surgery or radiation aimed at a cure. Participants must have measurable tumors, adequate organ function, and have experienced disease progression or intolerance to previous treatments, including chemotherapy or targeted therapies. Participants will receive TQB2102 for injection as the study treatment. The trial monitors the response to this drug over a period of up to 24 months. Female participants of childbearing age must agree to use contraception during the study and for six months afterward, and males must also agree to avoid pregnancy during this time. The study excludes individuals with recent surgeries, uncontrolled illnesses, certain lung diseases, recent other cancer treatments, or allergies to the investigational drug. Throughout the study, participants will undergo regular evaluations to assess tumor response according to standardized criteria. The primary outcome measured is the objective response rate, which will be assessed for up to two years from the start of the study. Safety monitoring and adherence to treatment protocols will be conducted continuously to ensure participant well-being and accurate study results.

Researchers are evaluating the safety and effectiveness of starting direct oral anticoagulants (DOACs) early versus later in patients who have acute ischemic stroke related to atrial fibrillation and who have undergone emergency endovascular therapy (EVT). This multicenter, prospective, open-label randomized controlled trial focuses on different timings to begin DOAC therapy to improve outcomes and reduce risks after stroke. Patients will be randomly assigned to one of two groups: the early anticoagulation group, which starts DOACs within four days of symptom onset, and the delayed anticoagulation group, which begins DOACs between 5 and 14 days after symptom onset. The study observes these treatment timings after emergency EVT for stroke, assessing their effects on patient safety and stroke recurrence. Participants will be monitored closely for 90 days after treatment to assess outcomes including recurrent ischemic stroke, symptomatic intracranial hemorrhage, and death from any cause. Evaluations include clinical assessments and imaging such as CT or MRI to detect hemorrhagic changes. Researchers will also review medical history, stroke severity, and treatment adherence. The study involves follow-up visits and data collection to ensure thorough safety and efficacy analysis over the three-month period.

Researchers are evaluating the safety and effectiveness of starting direct oral anticoagulants (DOACs) early versus delaying their start in patients who have had an acute ischemic stroke related to atrial fibrillation and developed bleeding in the brain after emergency endovascular treatment. This is a multicenter, open-label, randomized controlled trial focusing on different timings for beginning DOAC therapy to improve patient outcomes after stroke. Participants are assigned to one of two groups: early anticoagulation, where DOACs are started within 4 weeks after stroke symptoms begin, or delayed anticoagulation, where DOACs are started between 4 to 8 weeks after symptom onset. The study compares these two approaches to understand which timing is safer and more effective in managing stroke patients who experienced hemorrhagic transformation after treatment. During the study, patients will be monitored for a composite outcome including recurrent ischemic stroke, symptomatic brain bleeding, and death from any cause within 90 days. Researchers will conduct assessments and follow patients closely during this period to evaluate the effects of the timing of anticoagulant initiation. Participants will be followed up for 90 days to track these outcomes and assess safety and efficacy.

Researchers are studying the use of REKOVELLE® in women undergoing assisted reproductive technologies such as In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) to understand its effectiveness, safety, and how it is used in routine clinical practice. This multi-center, non-interventional study will take place in 30-50 sites across China, involving about 2500 women with infertility. The study aims to observe real-world use rather than testing new treatments experimentally. Participants will be women who are prescribed REKOVELLE® for the first time to help stimulate the ovaries during IVF or ICSI cycles. The study does not involve additional treatments or interventions but monitors the natural course of treatment with REKOVELLE® in clinical care. The total study duration is approximately 35 months, covering the treatment period and follow-up. During the study, researchers will collect data on live birth rates per initiated stimulation cycle over up to 15 months. Participants will provide written consent and be monitored through routine medical visits and assessments as per standard clinical practice. The study focuses on tracking safety, effectiveness, and patterns of REKOVELLE® use without altering usual care procedures.