Clinical trials

This is a single-arm, exploratory, phase II study evaluating the efficacy and safety of trastuzumab deruxtecan (T-DXd) in combination with pyrotinib in patients with HER2-positive advanced breast cancer whose disease has progressed after prior treatment with T-DXd.T-DXd is the established standard second-line therapy for HER2-positive advanced breast cancer. However, acquired resistance inevitably develops, and there is currently no approved standard treatment for patients progressing after T-DXd. Real-world studies report an objective response rate (ORR) of approximately 14.5% and a median progression-free survival of only 3 to 4 months in this setting, representing a major unmet medical need.Pyrotinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor that potently inhibits HER1, HER2 and HER4 kinase activity and blocks downstream PI3K/AKT and MAPK signaling. Preclinical and clinical data (including the HER2CLIMB-02 and TROPHY studies) support the synergistic potential of combining an anti-HER2 antibody-drug conjugate with a tyrosine kinase inhibitor.Participants receive T-DXd 5.4 mg/kg intravenously on Day 1 of each 21-day cycle plus pyrotinib 320 mg orally once daily, continuously, until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria. Tumor response is assessed using RECIST v1.1.The primary endpoint is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety/tolerability. Approximately 28 participants will be enrolled.

Lifestyle factors are among the most important modifiable risk factors for dementia, and primary prevention through lifestyle interventions is considered the most cost-effective approach to reducing the incidence of dementia. However, traditional face-to-face interventions have limitations that hinder large-scale implementation. With the development of primary healthcare systems, the delivery of simple, feasible, and brief lifestyle interventions within primary care settings offers a promising avenue for the continuous management and early prevention of dementia risk in older adults. In this study, brief lifestyle interventions were administered to older adults at risk of dementia by registered physicians at community health service centers.

The goal of this clinical trial is to learn if a technique called remote ischemic preconditioning (RIPC) helps protect organs during emergency surgery for acute type A aortic dissection (ATAAD). The main questions it aims to answer are: Does RIPC reduce the risk of major complications after surgery, such as heart, brain, or kidney problems? Is RIPC safe to use during emergency ATAAD surgery? Researchers will compare the RIPC group to a control group (who will receive a placebo) to see if RIPC can reduce complications after surgery. Participants will: Receive either RIPC or a sham intervention during their surgery. Be monitored for up to 30 days after surgery for complications. Have follow-up visits at 3 months, 1 year, and then yearly for up to 5 years to track their recovery.

This is a single-arm clinical study aiming to enroll 30 colon cancer patients with liver-only metastases. All eligible participants will undergo screening and enrollment after signing the informed consent form. All patients will receive stereotactic body radiation therapy (SBRT) targeting 1 to 3 liver lesions (each \< 3 cm) at a total dose of 50 Gy delivered in 5 fractions. For lesions adjacent to the liver capsule, portal vein or bile duct, the target volume can be expanded by 5-10 mm outside the visible lesion boundary. One week after radiotherapy completion, patients will be treated with QL1706 (Apalitamab-Tovorizumab, 5 mg/kg, iv, Q3W) combined with CAPOX plus bevacizumab. Preoperative treatment consists of up to 6 cycles, with each cycle lasting 3 weeks. Efficacy assessment will be conducted every 2 cycles. The investigator or multidisciplinary team (MDT) will decide to initiate curative treatment (surgical resection or radiofrequency ablation of liver metastases, combined with synchronous or staged resection of primary colon lesion) or continue conversion therapy. Surgery shall be scheduled 6 weeks after the final dose of bevacizumab. During the preoperative waiting period, one extra cycle of QL1706 (5 mg/kg, iv, Q3W) plus CAPOX is permitted. The interval between the last immunochemotherapy administration and surgery is required to be 2-3 weeks. Adjuvant therapy is scheduled to start 3 weeks after surgery, and must be initiated no later than 2 months postoperatively. The investigator will determine the use of QL1706 and/or bevacizumab in adjuvant setting according to individual patient conditions. If the time from surgery to adjuvant therapy is less than 4 weeks, the first postoperative cycle will use QL1706 (5 mg/kg, iv, Q3W) combined with CAPOX only. Postoperative QL1706 maintenance treatment will not exceed 1 year. Patients receiving postoperative systemic adjuvant chemotherapy will complete 8 cycles of perioperative CAPOX with or without bevacizumab. Patients with progressive disease (PD) or those who fail conversion therapy within 18 weeks will switch to alternative systemic regimens in accordance with the 2025 guidelines issued by the Chinese Society of Clinical Oncology (CSCO) and the National Comprehensive Cancer Network (NCCN). CAPOX + bevacizumab regimen (repeated every 3 weeks): Oxaliplatin: 130 mg/m², intravenous infusion over 2 hours, d1; Capecitabine: 1000 mg/m² per dose, po, bid, d1-14; Bevacizumab: 7.5 mg/kg, ivgtt, d1.

This study aims to evaluate the effectiveness and implementation outcomes of a dementia management competency training program for primary healthcare workers. A cluster randomized controlled trial will be conducted among primary healthcare institutions in Nanping, Fujian Province, China. Eligible primary health care providers will be recruited from community health service centers and township health centers.Participating institutions will be randomized in a 1:1 ratio to either a structured dementia management training group or a self-directed learning control group. The intervention group will receive a 12-week blended training program, including online learning, an in-person skills workshop, and case-based practice supervision. The control group will receive self-directed online learning materials. Outcomes will be assessed at baseline, immediately after the intervention, and 3 months after the intervention. The primary outcome is the change in dementia knowledge, measured using the Dementia Knowledge Assessment Scale. Secondary outcomes include dementia-related attitudes, dementia management practice competency, self-reported dementia management behaviors, objective screening and referral-related indicators, and implementation outcomes based on the RE-AIM framework.

This study aims to evaluate the performance of the PTAIR computer vision model for recognizing parathyroid glands and recurrent laryngeal nerves during endoscopic thyroid surgery. Multicenter intraoperative endoscopic surgery videos will be prospectively collected. Using the video recorder timeline as the unified time reference, the first recognition time of parathyroid glands and recurrent laryngeal nerves by PTAIR, junior physicians, and senior physicians will be recorded during surgery. The continuous recognition time of parathyroid glands and recurrent laryngeal nerves by PTAIR will also be recorded. This study focuses on the recognition performance of PTAIR in real-world multicenter endoscopic thyroid surgery settings. At this stage, PTAIR will not be used to guide intraoperative surgical decision-making, and the study will not evaluate the effect of PTAIR on clinical outcomes. The collected video data will be used to assess the performance of PTAIR under different centers, surgeons, equipment conditions, and surgical field conditions, and may provide data support for future model optimization.

This interventional study aims to evaluate the efficacy of a dyadic personalized home-based activity program in managing behavioral and psychological symptoms of dementia (BPSD) among home-dwelling people living with mild-to-moderate dementia post-discharge. The main question it aims to answer is: Does the dyadic personalized home-based activity program significantly reduce BPSD in individuals post-discharge with mild-to-moderate dementia? Researchers will compare individuals living with mild to moderate dementia who are receiving routine care to see if the dyadic personalized home-based activity program is effective for BPSD. Participants will: 1. In-hospital stage: A personalized home-based activity intervention plan is tailored for patients. Family caregivers receive professional training on care skills related to home-based activities and are provided with corresponding activity resources and support. 2. Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks. The intervention is recommended to be performed twice per week, with each session lasting about 30 minutes in accordance with the patient's individual tolerance. Intermittent rest is advised (e.g., a 2-3 minute break every 10 minutes). The weekly intervention frequency and session duration can be flexibly adjusted according to the family caregivers' schedule and the patient's condition, including mood fluctuations and physical discomfort. Family caregivers are required to record the patient's activity participation, subjective feelings and behavioral responses, and submit regular feedback to the research team. Based on feedback from patients and family caregivers, the research team will conduct dynamic adjustments and continuous optimization of the intervention program throughout the study.

This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.

This multicenter observational study aims to evaluate the safety and efficacy of neoadjuvant therapy in patients with locally advanced thyroid cancer, focusing on imaging, biochemical, and pathological responses, as well as short-term surgical outcomes and long-term prognosis.

Exploring the pathological complete response rate (pCR) of locally advanced gastric cancer treated with adebelimab combined or not combined with apatinib mesylate and SOX neoadjuvant therapy

This study aims to investigate whether adjunctive hyperbaric oxygen therapy, compared to guideline-directed medical therapy with the "New Four Pillars" (ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) alone, improves cardiac function in patients with chronic heart failure, and to evaluate its efficacy and safety.

This single-center, prospective, three-phase observational cohort quantifies the relationship between indocyanine green (ICG) fluorescence and early parathyroid function. Adult patients scheduled for unilateral thyroid lobectomy with autotransplantation of the ipsilateral inferior parathyroid gland are enrolled. After intravenous ICG 25 µg/kg, peak fluorescence of the superior parathyroid gland and the common carotid artery (CCA) is recorded at 60-120 seconds to calculate the ratio R = PTG/CCA. Serum parathyroid hormone (PTH) is measured 30 minutes post-operatively. A derivation cohort (\~120 patients) generates R-based thresholds for in-situ preservation versus autotransplantation, which are prospectively validated in an independent cohort (60 patients) together with decision-curve analysis of clinical net benefit.

This study evaluates a thyroid-function-preserving alternative to routine total thyroidectomy for bilateral papillary thyroid carcinoma (PTC). Eligible adults undergo remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI dissection on the dominant side, followed by ultrasound-guided radiofrequency ablation (RFA) of a ≤7 mm contralateral focus during the same anesthesia. Outcomes include structural-recurrence-free survival, endocrine-function preservation, safety, and quality of life over 24 months.

Primary hyperparathyroidism is usually cured by removing the single over-active parathyroid adenoma. During surgery, however, surgeons often see a thin rim of normal parathyroid tissue that still "glows" under a near-infrared parathyroid tissue sensor (PTS). It is unclear whether keeping this tissue in place helps preserve hormone function or whether it leaves behind cells that could become over-active again. The WHITE CAP study will compare two common surgical choices: Preservation strategy - the surgeon removes only the adenoma and leaves the glowing rim of normal tissue untouched. En-bloc strategy - the surgeon removes the adenoma together with the glowing rim; if too little parathyroid tissue remains, a small fragment is transplanted into the forearm muscle. About 120 adult patients who have a single parathyroid adenoma will be randomly assigned (like tossing a coin) to one of the two strategies. All operations will use the same FDA-cleared PTS camera that shows the glands in real time without dye or radiation. The main question is whether preserving the normal rim lowers the rate of temporary low blood-calcium (numbness, tingling) during the first two days after surgery. The study will also check long-term results-blood calcium and parathyroid hormone (PTH) levels, symptoms, and any return of the disease-over two years. The PTS imaging itself is painless and adds only a few minutes to the operation. Risks are the same as for standard parathyroid surgery, and participants can withdraw at any time without affecting their usual care.

Why: After thyroid or neck surgery, some patients can lose movement of both vocal cords (bilateral vocal-cord paralysis, BVCP). This can make breathing difficult and often leads to an emergency or preventive tracheostomy ("wind-pipe") surgery. What: This study will test two simple ways to avoid a tracheostomy: Pre-operative BiPAP sleep training - patients practice sleeping with a non-invasive BiPAP breathing machine for seven nights before surgery so they become comfortable with the mask and pressures. Immediate post-extubation BiPAP support - the same BiPAP machine is started as soon as the breathing tube is removed in the operating room or recovery area. How: Adults (18-80 years) who already have, or are at high risk of getting, BVCP will be randomly assigned to one of four groups in a 2 × 2 design: • Group 1: training + post-op BiPAP • Group 2: training only • Group 3: post-op BiPAP only • Group 4: standard care (no planned BiPAP). Main goal: To find out whether either or both BiPAP strategies reduce the need for tracheostomy or re-intubation during the first 7 days after surgery. What participants do: Eligible patients will undergo routine surgery plus the assigned BiPAP plan. Breathing events, comfort, hospital stay, and voice quality will be recorded up to 6 months. Potential benefit/risk: BiPAP is non-invasive and already FDA-cleared for home and hospital use, but some people may feel mask discomfort or air leaks. Trained staff will adjust settings and stop BiPAP if serious problems occur.

Why is this study being done? RET gene alterations occur in only 5-10 % of papillary thyroid cancers, but they can change how surgeons treat the disease. Gene testing is costly and not always performed, so many RET-positive tumours are missed. Researchers have built a computer program (artificial-intelligence or "AI" model) that reads routine thyroid ultrasound images and predicts whether the tumour carries a RET alteration and whether the cancer has already spread to lymph-nodes in the side of the neck. What will happen in this study? About 800 adults who are scheduled for thyroid-cancer surgery will take part. Each participant will: * have a standard pre-operative ultrasound exam (no extra scanning time), * give a routine fine-needle sample for a 14-gene panel test (results in 24 h), and * allow the AI model to analyse the ultrasound images in the background. Doctors making treatment decisions will not see the AI result. After surgery, the research team will compare the AI predictions with the gene-panel result and the final pathology report. Main goal: To find out how accurately the AI model detects RET alterations. Secondary goals: To measure the model's ability to predict lymph-node spread, and to compare costs between ultrasound-only prediction and full gene testing. Benefits and risks: Participants will receive the current standard of care; there is no added risk beyond the usual ultrasound and needle biopsy. The study could lead to faster, less expensive ways to identify high-risk thyroid cancers in the future.

This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.

This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. The goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.

Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.

Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.

This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.

This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory/resistant or steroid-dependent GVHD.

Imported Impella The price is relatively expensive and difficult for ordinary patients to afford. In order to better meet the growing clinical needs in China, Anhui Tongling Bionic Technology Co., Ltd. has developed an interventional left ventricular assist system. The test device was tested in preclinical animals It has shown good effectiveness and safety. Through the implementation of this clinical trial, the interventional left ventricular assist system The safety and effectiveness of the system for hemodynamic support in patients with cardiogenic shock have led to further development of this product in the country.

Prospective, multicenter, randomized controlled clinical trial plan to evaluate the effectiveness and safety of intraoperative stent system in the treatment of acute type I aortic dissection

Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.