Clinical trials

A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma

This clinical trial aims to find out whether a circadian-synchronized breast milk feeding approach can help improve sleep in preterm infants in the neonatal intensive care unit (NICU). The study mainly aims to answer the following questions: Can this feeding approach improve sleep in preterm infants? Can this feeding approach help preterm infants develop more regular sleep patterns compared with routine breast milk feeding? Researchers will compare a feeding approach that tries to match the time when breast milk was expressed with the time when the baby is fed, with routine breast milk feeding, to see whether this method can improve sleep in preterm infants. Participants will: Be randomly assigned to 1 of 2 groups: circadian-synchronized breast milk feeding or routine breast milk feeding. Receive the assigned feeding approach for at least 2 weeks during the study. Have one 12-hour continuous sleep monitoring session at 37 weeks of corrected age. Have changes in different sleep states recorded and analyzed during the study, so that sleep patterns can be compared between the 2 groups.

This prospective, self-controlled clinical study aims to evaluate the impact of proton pump inhibitor (PPI) use on the accuracy of stool DNA testing for Helicobacter pylori (H. pylori) and to assess the applicability of this test in patients receiving PPI therapy. Patients requiring long-term PPI treatment and meeting the inclusion criteria were enrolled. After at least four weeks of PPI therapy, a stool DNA test was performed, along with collection of gastric mucosal samples via gastroscopy for tissue PCR, histology, and rapid urease testing, as well as H. pylori antibody detection. Subsequently, PPI treatment was discontinued for four weeks, after which a 13C-urea breath test and a repeat stool DNA test were conducted. By comparing the sensitivity, specificity, and consistency of stool DNA testing before and after PPI discontinuation, this study aims to characterize the interference of PPIs with the test results, thereby providing evidence to support improvements in H. pylori diagnostic methods.

This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.

The purpose of this study is to explore the pathogenesis and genetic susceptibility of obese subjects,providing a convincing argument for further treatment of obesity and metabolic syndrome.

This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional distress.The investigators have developed an integrated "Product System" designed to transform the bracing experience from a burdensome task into a guided, supportive journey. This system consists of three main components:Smart Sensing: Discrete, thin-film pressure sensors are integrated into the existing brace to monitor real-time wear time and fit quality without compromising comfort.Interactive Desktop Terminal: A dedicated device for the home that uses "narrative-driven" feedback (themed around a journey called "The Spine's Path"). Instead of cold medical data, it provides intuitive progress visualizations and rewards to keep participants engaged.Mobile Support App: A tool for both participants and parents to track long-term trends, access educational resources, and facilitate communication with healthcare providers.The Goal of the Study The primary objective is to evaluate how this digital intervention affects a participant's "Intrinsic Motivation"-the internal drive to adhere to treatment. By focusing on three psychological dimensions-Interest/Enjoyment, Perceived Competence, and Pressure/Tension-the investigators aim to determine if interactive feedback can reduce the "medical feel" of the brace and help teenagers feel more in control of the recovery.What Participation Involves Participants will use the product system during the daily routine in home and school environments. The investigators will collect objective data (brace usage hours) and subjective data (through the Intrinsic Motivation Inventory/IMI scale) to measure changes in behavior and mental well-being.Benefits for Families and ProvidersFor Participants: A more engaging, less stressful way to manage the condition and see real-time progress.For Families: Reduced friction regarding brace-wearing and better visibility into the participant's treatment status.For Healthcare Providers: Access to accurate, objective data on participant compliance, allowing for more personalized and effective clinical adjustments.

This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).

To investigate biomarkers to identify pediatric SR-SLE patients by non-invasive echocardiographic techniques.

Cutaneous T-cell lymphomas (CTCL) are a rare and heterogeneous group of extranidal T-cell lymphomas characterized by skin involvement. Current treatment options for CTCL are limited. Although responses have been demonstrated, their duration is often short, especially in patients with advanced stage disease. Additional treatment options are needed which demonstrate activity in cutaneous and extracutaneous sites. The traditional CHOP regimen (Cyclophosphamide, Hydroxydaunorubicin, Vincristine and Prednisone) has some efficacy for CTCL patients, but due to the cardiotoxicity of anthracyclines, patients can only receive a limited course of treatment. After stopping the regimen, most patients will experience relapse. Aclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. Aclarubicin's treatment indications include malignant lymphoma, but actual clinical application experience is limited. The purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with cyclophosphamide, vincristine, and prednisone (CAOP) for subjects with relapsed or refractory CTCL.

Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of rare disorders that result from clonal proliferation of mature post-thymic lymphocytes. These T-cell neoplasms account for approximately 10-15% of all lymphomas. The most common subtype of PTCL is classified as "not otherwise specified" (NOS) which accounts for 30-40%. PTCLs have been treated similarly with CHOP (Cyclophosphamide, Hydroxydaunorubicin, Vincristine and Prednisone), often with etoposide (CHOEP), followed by high-dose therapy and autologous stem cell transplantation (ASCT) in first remission. However, \<50% of the patients are cured with CHOP alone, and the progression-free survival rates at 5 years are as low as 20% for PTCLs. Meanwhile, for elderly patients who can't endure CHOPE and proceed ASCT, the long-term survival is even worse. Aclarubicin is an anthracycline which showed good safety profile in the treatment of both myeloid and lymphocytic leukemia. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. The purpose of this study is to determine the efficacy of Aclarubicin, Cyclophosphamide, Vincristine, and Prednisone (CAOP) in elderly patients with newly diagnosed PTCLs. The investigators hope to try to replace doxorubicin in CHOP with aclarubicin, which is less toxic, without reducing the efficacy of patients while ensuring safety.

Treatment of advanced endocrine tumors, including adrenal corticocarcnioma (ACC), medullary thyroid carcinoma (MTC), thymic neuroendocrine tumor and pancreatic neuroendocrine tumor is challenging. Previous genomic profiling studies showed they presented a number of somatic mutations. The tumors Individualized mRNA neoantigen vaccine provide a promising solution since a significant portion of these tumors showed high quality of tumor specific neoantigen. The primary objective is to observe and evaluate the safety and tolerability of individualized mRNA neoantigen vaccine (mRNA-0523-L001) for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available. The secondary objective is to observe the preliminary efficacy of mRNA-0523-L001 for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available, including: 1. Neoantigen-specific CD4+ and CD8+ T lymphocyte responses induced by mRNA-0523-L001; 2. Objective response rate (ORR) and disease control rate (DCR) of tumors; 3. Progression-free survival (PFS).

This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy

Acute myeloid leukemia Acute myeloid leukemia (AML) is a clonal hematopoietic cancer that disrupts normal hematopoiesis, ultimately leading to bone marrow failure and death. The annual incidence rate of AML is 4.1 per 100000 people in the US and is higher in patients older than 65 years. There has been a steady improvement in survival over the decades, more noticeably so in younger patients and in the last decade. Azacitidine and Venetoclax is now the standard treatment of newly diagnosed AML ineligible for intensive chemotherapy, while still facing the dilemma of relapse and refractory disease. Anthracycline-based chemotherapeutics were wildly used in the treatment of fit AML patients. While the cardiovascular toxicity leading to morbidity and mortality limited the use of daunorubicin/idarubicin in unfit patients. Aclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. CAG regimen, combined with low-dose cytarabine, aclarubicin and G-CSF has been widely used in China and Japan for treatment of AML. The purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with azacitidine and venetoclax for subjects with newly diagnosed and relapsed /refractory AML.

This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.

In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML \>=55 years.

This is a single-arm, open-label, dose-escalation clinical trial. The entire trial is preliminarily expected to enroll 5 to 9 subjects. The initial plan is to explore three dose groups: 2.5×10⁷, 7.5×10⁷, and 2.5×10⁸ cells/kg, with 3 subjects in each group. During the trial, based on a comprehensive assessment by the Safety Review Committee (SRC), the dose, dosing frequency, or dosing interval may be adjusted or increased. In the dose-escalation phase, for the same dose group, one subject will be enrolled first. After obtaining at least 4 weeks of safety data, and upon the investigator's assessment confirming that the safety and tolerability risks are controllable, the second and third subjects can be enrolled. If the efficacy and safety data of the first subject in a dose group, based on the investigator's comprehensive judgment, indicate a significantly insufficient pharmacological effect, the study may proceed directly to the next dose group. Before proceeding to each subsequent dose group, the SRC must evaluate the safety and pharmacodynamic data from the previous dose group for at least 4 weeks. Enrollment for the next group can only begin after the SRC confirms that the safety and tolerability risks are controllable and that the next dose level remains appropriate. The dose escalation will be determined based on safety data, combined with pharmacodynamic and efficacy data.

To evaluate the safety and tolerability of intracerebral injection of VGN-Ex05e in the nucleus accumbens of patients with autism spectrum disorder.

Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response/near radiological complete response (rCR/near rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery. If cCR/rCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.

1. Complete a large-sample, multicenter, randomized blank-controlled clinical trial to evaluate Shenling Baizhu Granules for the prevention of colorectal adenoma recurrence. 2. Generate high-level, internationally recognized clinical evidence to support the development of clinical practice guidelines for the prevention and treatment of colorectal adenoma using traditional Chinese medicine, and to strengthen the recommendation level of Shenling Baizhu Granules in clinical guidelines. 3. Define the clinical characteristics of patient subgroups most likely to benefit from Shenling Baizhu Granules for preventing colorectal adenoma recurrence.

This is a Prospective, Single-center, Open-label, Single-arm Clinical Study to Evaluate the Safety and Efficacy of CS-121, an In Vivo Base Editing Therapy Delivered by Lipid Nanoparticles Targeting APOC3, in Children and Adolescents (4-18 years) With Hyperchylomicronemia

This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. The study aims to evaluate the efficacy and safety of Sac-TMT combined with KL-A167 as neoadjuvant treatment for triple-negative breast cancer.

This study is a single arm, open label Phase Ib clinical trial, consisting of two parts: the first part is a safety introduction trial, and the second part is a dose escalation trial. In the first part, the tolerability, safety, PK characteristics, PD characteristics, and preliminary efficacy of VIC-1911 tablets in combination with PTCy and sirolimus will be explored. The first part will conduct safety introduction tests at the same dose as those already tested abroad to determine the dosage required for VIC-1911 tablets to meet safety and effective biological activity. The dose limiting toxicity (DLT) in Phase I study will be evaluated from the first administration of VIC-1911 tablets to 28 days after administration. On this basis, the second part of the experiment will be conducted to further explore the effectiveness and safety of VIC-1911 tablets combined with PTCy and sirolimus under RP2D for preventing GVHD in haplo HSCT patients after myeloablative pretreatment

To validate the feasibility of promoting colorectal diminutive polyp "predict, resect, and discard" and "diagnose and leave" strategies for non-experts in general hospitals through CADx system.

Confocal technology, hailed as "optical biopsy," enables real-time cellular-level histological examination of mucosal surfaces. Its integration with double-balloon enteroscopy significantly enhances the clinical feasibility of targeted biopsy, early diagnosis, and endoscopic staging for small bowel diseases such as inflammatory bowel disease. Currently, confocal endoscopy is primarily applied to upper and lower gastrointestinal tract diseases, leaving small bowel pathologies largely unexplored. Consequently, establishing a diagnostic framework for small bowel tumors and non-neoplastic lesions using confocal enteroscopy, alongside developing quality assessment standards for its operational procedures, is of paramount importance.

Gastrointestinal endoscopy procedures, including upper gastrointestinal endoscopy and colorectal endoscopy, represent a fundamental and important method for examining and managing digestive tract diseases, with both diagnostic and therapeutic applications. They are also utilized as effective tools for surveillance of gastrointestinal tumors. During upper gastrointestinal endoscopy procedures, gastric peristalsis may restrict the operative field of view and access, significantly affecting procedural precision. Excessive peristalsis not only affects the observation of simple lesions but also impacts other procedural maneuvers Therefore, during upper gastrointestinal endoscopy procedures, antispasmodic agents are commonly used to suppress gastrointestinal motility, ultimately facilitating endoscopic visualization. However, most antispasmodic agents, such as hyoscine butylbromide (Buscopan), cimetropium bromide (Algiron), and atropine, must be administered by injection. Intravenous or intramuscular administration causes patient pain and anxiety, and increases medical costs. Some researchers have taken an alternative approach by spraying L-menthol onto the gastric mucosa during gastroscopy to reduce gastric peristalsis. Although study results and adverse reaction profiles have demonstrated its superiority, the application process still presents operational inconveniences. Furthermore, these drugs should be used with caution as they may cause potential adverse reactions, including dry mouth, urinary retention, temporary impairment of visual accommodation, palpitations, anaphylactic shock, and hyperglycemia.