Clinical trials

The goal of this project is to quantify the effectiveness and safety of escitalopram oxalate oral solution in the treatment of first-episode, drug-naïve patients with major depressive disorder, and to explore the mechanisms underlying its antidepressant effects using multi-omics approaches. By integrating clinical, cognitive, laboratory, imaging, genetic, and environmental data, the study aims to identify patient subgroups who are most likely to benefit from escitalopram, thereby promoting individualized and precision treatment for depression. This multicenter, prospective, single-arm intervention study will enroll 200 adults aged 18-65 years with major depressive disorder, who will receive escitalopram oxalate oral solution for 8 weeks. Depressive symptoms, cognitive function, and adverse events will be assessed at baseline, during treatment, and after 8 weeks of treatment to evaluate efficacy and safety. Escitalopram blood concentrations will be measured at week 4 to monitor treatment adherence and support safety evaluation. Through comprehensive data collection and multimodal analysis, this project seeks to clarify the biological mechanisms of escitalopram and provide evidence to guide more precise clinical use of antidepressant therapy.

A randomized controlled phase II study exploring first-line treatment options for recurrent/metastatic MSI-H gastric cancer

This cluster-randomized controlled trial will evaluate whether a 3-month culturally adapted blood pressure-lowering dietary, called the Eastern Blood Pressure-Lowering Diet, can improve blood pressure and related health outcomes in Chinese adults with primary hypertension. Approximately 800 participants from 16 workplace-based clusters will be assigned to either a standard hypertension management group or a dietary intervention group. Both groups will receive usual hypertension care, including health education and medication treatment when clinically indicated. In addition, participants in the dietary intervention group will receive specially designed weekday lunches, low-sodium salt and reduced-sodium seasonings, and app-based support for dietary recording and adherence monitoring. The main outcome is change in resting systolic and diastolic blood pressure. Other outcomes include body weight, waist circumference, body fat, blood glucose, blood lipids, homocysteine, kidney function, estimated 24-hour urinary sodium and potassium excretion, lifestyle behaviors, sleep, psychological well-being, and the occurrence of hypertension-related complications or cardiovascular and cerebrovascular events. Blood, urine, and stool samples will also be analyzed to explore possible metabolic and gut microbiome mechanisms underlying the effects of the dietary intervention. The active dietary intervention will last 3 months, and participants will be followed for up to 24 months.

This is a randomized controlled trial examining the efficacy and neural mechanisms of a standardized Mindfulness Intervention for Emotional Distress (MIED) in adults with subclinical emotional distress. One hundred and sixty participants will be randomly assigned to either an 8-week MIED program or an 8-week Progressive Muscle Relaxation (PMR) active control. The primary aim is to evaluate whether MIED reduces anxiety symptoms and reshapes multilevel emotional processing as measured by multimodal EEG (resting-state FAA/theta, Fast Periodic Visual Stimulation, and event-related potentials). Assessments occur at baseline (T1), post-intervention (T2), and 1-month follow-up.

This multicenter, three-arm randomized controlled trial will evaluate the effects of early time-restricted eating and staple food reduction, each combined with an app-supported exercise intervention, on body weight and glycemic control among adults with obesity and abnormal glucose metabolism. A total of 300 participants aged 18 to 50 years with BMI \>=28 kg/m2 and impaired glucose regulation or diabetes will be enrolled at five centers in China and randomized 1:1:1 to app-supported exercise alone, staple food reduction plus app-supported exercise, or early time-restricted eating plus app-supported exercise. The intervention lasts 12 weeks, followed by a 12-week post-intervention follow-up.

The goal of this clinical trial is to learn how the order of exercise and the order of eating food affect weight management in overweight and obese children and adolescents. The main questions it aims to answer are whether doing aerobic or anaerobic exercise first changes weight loss results, and whether eating vegetables and proteins before carbohydrates improves health outcomes compared to a standard diet. Furthermore, the study asks how the exercise order and eating order work together to affect weight and health. Researchers will compare four different groups to see if these specific exercise and eating orders work better to treat obesity. Participants will stay at a closed weight loss camp for 28 days and do daily aerobic and anaerobic exercises in a randomly assigned order. They will eat meals in either a strict order, consuming vegetables and proteins first, or a standard order. Throughout the trial, participants will give blood, urine, stool, saliva, and sweat samples for lab tests, while also checking their body weight, body composition, and heart rate. Finally, they will answer surveys about their diet, physical activity, hunger, and tiredness.

This multicenter, prospective, randomized parallel-controlled, assessor-blinded clinical trial aims to address the core clinical pain point of lack of high-level evidence and non-standardized operation in injection site selection for BTX-A treatment of oral commissure ptosis. A total of 266 eligible subjects will be randomly assigned in a 1:1 ratio to receive either upper DAO or lower DAO BTX-A injection. The study will compare the clinical efficacy, time-effect characteristics and safety profiles of the two regimens, and conduct stratified analysis of treatment response in different patient subtypes. The results will determine the optimal injection site for Chinese population, establish standardized operation specifications, fill the international evidence gap, and provide level I evidence for clinical practice.

This study is a randomized, controlled, open-label phase III clinical trial, aims to compare the efficacy and safety of Retlirafusp alfa injection plus CAPOX versus the investigator's choice of anti-PD-1 antibody plus CAPOX as first-line treatment in patients with advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC) with liver metastases

The goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (EVM16) alone or in combined with an anti-PD-1 antibody (tislelizumab) . This clinical trial will include solid tumor patients who failed standard treatment. The main questions to answer are: Safety of EVM16. Suitable dose of EVM16. Effects of EVM16 combined with tislelizumab.

Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis.

Study Title: Determining the Presence of Salt Sensitivity in Individuals With Elevated Blood Pressure Through Dietary Salt Interventions: A Series of N-of-1 Trials Objective: To evaluate whether there are differences in blood pressure responses to dietary sodium intake between salt-sensitive and salt-resistant individuals, as identified through a salt sensitivity test. The study will use repeated dietary interventions with varying sodium content (high-sodium, low-sodium) to assess blood pressure responses in each individual, aiming to determine whether salt sensitivity is a present characteristic. Study Design: This study will utilize an N-of-1 randomized controlled trial design. It consists of two phases: Salt Sensitivity Screening: A 2-week chronic salt-loading test will be used to identify salt-sensitive and salt-resistant individuals. N-of-1 Trial: The identified salt-sensitive and salt-resistant individuals will undergo a 6-week N-of-1 trial, consisting of three cycles, with each cycle including one week of low-sodium diet and one week of high-sodium diet. This design aims to assess individual blood pressure responses to changes in sodium intake. Sample Size: A total of 72 participants will be recruited for the salt sensitivity screening, with an expected 24 participants proceeding to the N-of-1 trial. Study Population: Healthy individuals aged 20-65 years, not on antihypertensive medication or with a stable regimen for at least 3 months, with systolic blood pressure between 110-159 mmHg and diastolic blood pressure between 70-99 mmHg, who are able to eat at the research center. Primary Outcome: Reproducibility of salt sensitivity response classification. Secondary Outcomes: Changes in mean arterial pressure, systolic and diastolic blood pressure; exploratory outcomes such as sleep, mood, gut microbiome, metabolomics; safety outcomes including hypotension and hyponatremia.

Autism spectrum disorder (ASD) is an increasing public health concern, with preschool children often exhibiting persistent deficits in school readiness. However, targeted and developmentally comprehensive interventions remain limited. This randomized controlled trial will evaluate a 12-week Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 children with ASD aged 3-6 years, compared with a Treatment As Usual (TAU) control group. The program integrates progressive FMS training with CrossFit-style circuit training to improve motor competence, social interaction, and self-regulation. Primary outcomes focus on school readiness assessed by the Strengths and Difficulties Questionnaire (SDQ), while secondary outcomes include motor development, executive function, social responsiveness, and biomarkers. Assessments will be conducted at baseline, mid-intervention (8 weeks), post-intervention (12 weeks), and follow-up (20 weeks).

This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability

This study aims to examine the effectiveness of group Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.

Prolonged Grief Disorder (PGD) is a severe, disabling condition characterized by intense yearning and difficulty accepting the reality of loss, which significantly impairs the academic and psychosocial functioning of bereaved adolescents. While Grief-Focused Cognitive Behavioral Therapy (GF-CBT) is effective, its high cost and resource-intensive nature limit its accessibility for adolescents in mainland China. Grief-Focused Guided Narrative Writing (GF-GNW) offers a scalable, low-cost alternative that facilitates memory integration. Furthermore, integrating Artificial Intelligence (AI) to provide personalized, structured feedback has the potential to simulate therapist functions and enhance intervention efficacy. However, the specific efficacy of AI-assisted feedback in this context remains empirically unvalidated. This parallel randomized controlled trial aims to examine the effectiveness of AI-assisted GF-GNW (AI-GF-GNW) in treating Chinese adolescents (aged 10-19) with subclinical PGD, compared to a no-feedback NF-GF-GNW group and a free writing group. Primary outcomes include PGD symptom severity, while secondary outcomes assess depression, anxiety, and daily functioning. We hypothesize that both active intervention arms will significantly alleviate PGD and related symptoms compared to the free writing group, and that the AI-GF-GNW group will demonstrate a significantly greater reduction in symptoms and functional impairment than the NF-GF-GNW group.

Biliary tract cancer (BTC), including cholangiocarcinoma and gallbladder cancer (GBC), is a group of malignancies with highly heterogeneous, highly aggressiveness, and poor prognosis. Surgery is recognized as the only curative treatment for BTC, however, only about 20% BTC patients are eligible for curative resection since most patients with BTC are diagnosed at an advanced stage. The median overall survival (OS) in patients with unresectable BTC is typically less than 6 months. For patients with unresectable BTC, gemcitabine plus cisplatin (GemCis) had been recommended as the standard first-line treatment for many years. However, the objective response rate (ORR) of this regimen is only 26.1%, and the survival benefit remains limited, with a median OS of less than one year. In recent years, two phase III trials (TOPAZ-1 and KEYNOTE-966) have demonstrated that combining immune checkpoint inhibitors (durvalumab or pembrolizumab) with the GemCis regimen could further prolong survival in patients with BTC, achieving a median OS of 12.9 months and 12.7 months, respectively. Based on this evidence, many guidelines worldwide had recommended GemCis plus durvalumab or pembrolizumab as the preferred standard first-line treatment for patients with unresectable BTC. However, survival benefits from this combination therapy remain relatively limited, and tumor response is suboptimal, with an ORR of only 26.7%-29%. Hepatic arterial infusion chemotherapy (HAIC) enables continuous infusion of chemotherapeutic agents via the hepatic artery, significantly increasing local drug concentration at the tumor site, maximizing antitumor efficacy, and achieving a higher ORR (50%-60%) with substantial reduction in tumor burden. In recent years, HAIC has been increasingly used in the treatment of unresectable BTC, with its efficacy supported by many clinical studies. Firstly, HAIC provides survival benefits comparable to surgery in patients with multifocal intrahepatic cholangiocarcinoma (iCCA), and significantly outperforms systemic therapy. In 2022, a retrospective study enrolled 141 patients who received HAIC and 178 patients who underwent surgical resection from 12 centers. The results showed the median OS was 20.3 months in the HAIC group and 18.9 months in the resection group (P = 0.32), indicating comparable survival outcomes between HAIC and surgery. Given the risks of post-hepatectomy complications, HAIC may serve as an effective alternative treatment strategy for multifocal iCCA. Furthermore, for locally advanced unresectable iCCA, the results in a study in 2024 comparing HAIC with GemCis regimen chemotherapy revealed that although patients in the HAIC group had a higher tumor burden (proportion of multifocal disease: 73.4% vs. 55.3%, P = 0.023), the median OS in HAIC group remained significantly superior to that in the GemCis group (27.7 months vs. 11.8 months, P \< 0.001). Secondly, HAIC has also been demonstrated to be effective in treating perihilar cholangiocarcinoma (pCCA). In 2017, a single-arm, prospective phase II trial conducted in our center showed HAIC with oxaliplatin and fluorouracil yielded an ORR of 67.6%, a median progression-free survival (PFS) of 12.2 months, and a median OS of 20.5 months in treating perihilar cholangiocarcinoma (pCCA). Furthermore, HAIC also has clinical potential in treating advanced GBC. In 2021, a retrospectively study in our center enrolled 26 patients with advanced GBC who received HAIC with oxaliplatin and fluorouracil, of whom 23.1% had failed prior systemic therapy and 34.6% had contraindications to systemic treatment. The results showed that HAIC achieved a median PFS of 10 months and a median OS of 13.5 months, with an ORR of 69.2% and a disease control rate (DCR) of 92.3%. In recent years, many studies have demonstrated that HAIC combined with systemic therapy could yield significant survival benefits in patients with unresectable BTC. A phase II clinical trial in 2022 evaluated the efficacy of HAIC with floxuridine plus systemic gemcitabine and oxaliplatin (GEMOX) in unresectable iCCA. The results showed that the combination therapy achieved a median PFS of 11.8 months and a median OS of 25 months, with a 6-month DCR of 84%, and 58% of patients achieved partial response (PR). Additionally, the association of benefit of combining HAIC with systemic chemotherapy and stage of BTC has been reported, and that patients with locally advanced cholangiocarcinoma may not derive such benefit from this combination. In 2025, a phase II clinical trial conducted in our center evaluated the efficacy and safety of HAIC (bevacizumab, oxaliplatin, and fluorouracil) combined with toripalimab as a first-line treatment for unresectable BTC. The results showed a median PFS of 13.2 months and a median OS of 19 months, with an ORR as high as 84.38%. Some patients achieved successful conversion resection following this combination therapy, and postoperative pathology confirmed pathological complete res

The goal of this clinical study is to learn how Mindfulness Intervention for Emotional Distress (MIED) helps people with emotional distress and how their symptoms and psychological patterns change over time. The main questions it aims to answer are: * How do the relationships between emotions, thoughts, and behaviors change week by week during mindfulness training? * Which psychological skills, such as distress tolerance or cognitive flexibility, improve first and lead to later emotional relief? Two groups will be compared - one that takes part in an online mindfulness intervention and one that waits to join - to see how the intervention changes emotional and psychological networks over time. Participants will: * Complete a 7-week online self-guided Mindfulness Intervention for Emotional Distress（iMIED） designed for people experiencing high emotional distress. * Fill out short weekly questionnaires about their emotions, thoughts, and behaviors before, during, and after the course (9 times in total). * Receive access to the mindfulness program after the study if they are in the wait-list group. This study includes about 500 adults aged 18 and older who feel anxious, depressed, or emotionally distressed but have no major psychiatric disorders. By tracking weekly changes, the research aims to identify how mindfulness intervention leads to emotional improvement and which skills play the most important roles in that process.

Numerous studies have demonstrated that circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) detection has significant clinical value in postoperative recurrence monitoring, adjuvant treatment decision-making, and early intervention. Our previous retrospective study, using fixed ctDNA-MRD, confirmed that postoperative ctDNA-MRD can predict recurrence risk. Therefore, we plan to conduct a further prospective, multicenter, observational study, utilizing a combination of personalized ctDNA-MRD and fixed MRD panels, to dynamically monitor gastric cancer patients who have received neoadjuvant therapy followed by curative resection. The study will systematically analyze the correlation between ctDNA-MRD status and tumor recurrence and metastasis, assess its sensitivity and specificity in recurrence prediction, and compare its early warning advantage over traditional imaging techniques in predicting recurrence.

The goal of this clinical trial is to evaluate the effectiveness and cost-effectiveness of a digital mindfulness-based intervention in adults (aged 18-65) diagnosed with emotional disorders like depression or anxiety. The main questions it aims to answer are: * Does adding a digital mindfulness intervention to usual care help people recover from emotional disorders faster and more sustainably over two years? * Is this combined approach more cost-effective than usual care alone? Researchers will compare the group receiving the digital mindfulness intervention plus their usual treatment to the group receiving only their usual treatment to see if the intervention leads to better long-term recovery and represents good value for money. Participants in the intervention group will: * Attend eight weekly 2-hour online group mindfulness sessions. * Use a WeChat mini-program for 49 days of guided mindfulness exercises and daily tasks. * Patients who have not achieved reliable recovery after group retraining voluntarily participate in individual UP\&MIED counseling. * Complete regular questionnaires and interviews over two years to track their progress. All participants will continue to receive their usual medical care from their doctors throughout the study.

The goal of this study is to evaluate the effectiveness of a school-based weight management intervention delivered through a digital platform (WeChat) in preventing excessive weight gain and improving health behaviors in school-aged children in Fangshan District, Beijing. The main questions it aims to answer are: Does the intervention group show a significantly lower mean increase in BMI, body fat percentage, and waist circumference compared to the control group? Does the intervention group show a significantly lower obesity rate and new obesity incidence compared to the control group? Does the intervention group show significant improvements in healthy eating, sedentary behavior, sleep, physical activity, and physical fitness test scores compared to the control group? Researchers will compare children in intervention schools (who receive the multi-level intervention targeting students, families, and schools, supported by a digital platform for behavior monitoring and feedback) to children in control schools (who do not receive the intervention during the study period). Participants in the intervention group will: (1) attend 10 student health education sessions; (2) have their physical activity at school increased to 60 minutes/day of moderate-to-vigorous activity; (3) have parents attend health education lectures and use a WeChat platform to receive health information, log child health data, and receive automated feedback; (4) have their height, weight, waist circumference, and body composition measured monthly by school health staff; and (5) be followed with assessments at 6, 12, and 24 months.

This study aims to develop and evaluate an early risk identification and digital health intervention strategy for gestational diabetes mellitus (GDM) among pregnant women in China. Gestational diabetes mellitus is a common pregnancy complication associated with adverse maternal and neonatal outcomes, including excessive gestational weight gain, macrosomia, cesarean delivery, and increased long-term risk of metabolic disorders in both mothers and offspring. The study includes two components. First, retrospective multi-source clinical data from maternal health records will be used to develop and validate a risk prediction model for early identification of pregnant women at high risk of GDM. Second, pregnant women identified as high risk in early pregnancy will be enrolled in a multicenter randomized controlled trial and assigned to either a digital health intervention group or a usual care group. The intervention includes online health education, individualized lifestyle guidance, behavioral self-management tools, and interactive consultation through a digital platform. The primary outcome is the incidence of GDM diagnosed during pregnancy. Secondary outcomes include gestational weight gain, cesarean delivery, macrosomia, and other maternal and neonatal outcomes. This study is expected to provide evidence for improving early risk assessment, intelligent warning, and prevention strategies for GDM in the context of maternal health management in China.

The goal of this clinical trial is to learn the safty characteristics of SIG001 Mab in cancer patients; It will also determine the Recommended Phase II dose of SIG001 Mab on cancer treatment, and pharmacological characteristics of SIG001. The main questions it aims to answer are: What is the safety and tolerability of SIG001 in patients with advanced solid tumors ? What is the Recommended Phase II dose of SIG001? What is the PK/PD characteristics of SIG001 in cancer patients? What is the antitumor activity of SIG001 in cancer patients? What is the immunogenicity of SIG001 in cancer patients? What is the relationship between the exposure/dose of SIG001 and its safety as well as clinical efficacy? What is the expression levels of potential biomarkers (such as SIG), if applicable, and analyze their correlation with drug exposure, efficacy, and safety? What is event-related endpoints such as the Duration of Response and Progression-Free Survival in patients treated with SIG001? This will be a single-armed study. Participants will: Intravenously Inject SIG001 every two weeks, for 4 weeks Visit the clinic on the 14th day, 30th day, and 90th day afer the last injection. Then visit the clinic for every 12 weeks.

To evaluate the safety and tolerability of intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).

The goal of this cluster randomized clinical trial is to learn if an AI-enabled blended care model (the BRIDGE program) works to treat type 2 diabetes in adults. It will also learn about the cost-effectiveness and implementation feasibility of this model in primary care settings. The main questions it aims to answer are: Does the AI-driven intervention lower HbA1c levels (blood sugar) compared to standard care? Does this model improve participants' quality of life, self-management behaviors, and digital literacy? Researchers will compare the "Diet-Medicine Companion" (Shi Yi Ban Lv) mini-program combined with family doctor support to standard community care to see if the blended care model works to manage diabetes. Participants will: Use the "Diet-Medicine Companion" mini-program to upload diet photos daily and receive AI feedback for 6 months Receive periodic guidance and phone reminders from case administrators (family doctors) Complete questionnaires and blood tests (HbA1c) at baseline, 3 months, and 6 months

The PREG-Salt study is to evaluate the effect, safety and cost-effectiveness of low-sodium salt in reducing blood pressure and preventing hypertensive disorders in pregnant women at high risk in China. The study will recruit about 3,200 participants from approximately 100 hospitals across multiple provinces in China. Eligible pregnant women (≤16 weeks of gestation) will be randomly assigned in a 1:1 ratio to the following 2 groups: 1. Salt subsittute(intervention); 2. Usual salt (control) . The intervention will last until delivery. The study employs an adaptive two-phase design. An interim analysis after the first phase (n=400) will inform whether the trial continues into the second phase and if any adjustments to the sample size are needed. The primary outcomes are: Phase 1: The mean systolic blood pressure across antenatal visits (excluding the last week before delivery). Phase 2: New-onset hypertensive disorders of pregnancy and related adverse events from randomization to delivery.