Clinical trials

36

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time

To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.

Participants needed: 142
Trial details
Phase: Phase 4Age: 18-70Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Jun 22, 2026
Eligibility criteria

Male or female individuals aged 18-70 years old. [+4]

Has secondary hyperuricemia. [+14]

Status: Not yet recruiting

Edaravone Dexborneol for Post-Stroke Epilepsy

This is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of Edaravone Dexborneol sublingual tablets in preventing late-onset epilepsy in patients with acute ischemic stroke at high risk. Eligible participants are adults aged 18-80 years with a confirmed diagnosis of acute ischemic stroke by clinical and imaging criteria (MRI or CT), enrolled within 48 hours of stroke onset. High risk for post-stroke epilepsy is defined as a SeLECT-EEG score ≥7. Patients must have no prior history of epilepsy or other central nervous system disorders associated with seizures. Key exclusion criteria include prior seizures before enrollment, recent stroke within the past 12 months, severe renal or hepatic dysfunction, significant cardiac insufficiency, drug hypersensitivity, pregnancy or lactation, and other conditions deemed unsuitable by investigators. A total of approximately 160 participants will be randomized in a 1:1 ratio to receive either Edaravone Dexborneol sublingual tablets or matching placebo. The primary endpoint is a composite outcome assessed within 2 years, defined as the occurrence of either: (1) definite clinical epileptic seizures, or (2) new-onset or worsening epileptiform EEG abnormalities (including IEDs, PDs, LRDAs) or electrographic seizures. Secondary endpoints include: incidence of individual components of the primary outcome; time to first seizure; characteristics, severity, and frequency of seizures; longitudinal changes and resolution rate of epileptiform EEG activity; cognitive function assessed by MoCA and MMSE; neurological outcomes evaluated by mRS and NIHSS; quality of life and functional independence measured by SSQOL and Barthel Index; recurrence of stroke and all-cause mortality; changes in inflammatory biomarkers (TNF-α, IL-1β, COX-2, iNOS); and safety outcomes including treatment-emergent adverse events, serious adverse events, laboratory abnormalities, and treatment discontinuation due to adverse events. All efficacy and safety outcomes will be independently reviewed by a blinded adjudication committee. Statistical analyses will include chi-square or Fisher's exact tests for categorical outcomes, Kaplan-Meier survival analysis with log-rank tests for time-to-event data, and Cox proportional hazards models to adjust for potential confounders. The study period is planned from June 2026 to June 2030.

Participants needed: 160
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: May 22, 2026Locations: 1
Eligibility criteria

Adults aged 18 to 80 years, of either sex.

History of epilepsy or occurrence of any seizure prior to screening.

Status: Recruiting

Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment. The primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT/OCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.

Participants needed: 200
Trial details
Phase: Phase 4Age: 50-90Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: May 22, 2026Locations: 1
Eligibility criteria

Age: 50 to 90 years old. [+6]

Patients with cognitive impairment caused by reasons other than AD. [+9]

Status: Not yet recruiting

Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.

Participants needed: 60
Trial details
Phase: Phase 2Age: 40+Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: May 13, 2026
Eligibility criteria

Age ≥40 years old, regardless of gender; [+7]

Suffering from other interstitial lung diseases caused by non-IPF reasons (such... [+12]

Status: Recruiting

Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial

To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.

Participants needed: 90
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: May 14, 2026Locations: 1
Eligibility criteria

Age between 18 and 75 years inclusive.

Clinical stage T4 or presence of distant metastasis.

Status: Not yet recruiting

Intelligence System for Predicting Atezolizumab-Bevacizumab Response and Clinical Outcomes in Unresectable Hepatocellular Carcinoma

This study is a multicenter retrospective clinical research, led by the First Affiliated Hospital of Wenzhou Medical University, and jointly conducted by other sub-centers. The aim is to develop an non-invasive artificial intelligence system for predicting the response and clinical outcomes of patients with unresectable hepatocellular carcinoma (uHCC) to the treatment with atezolizumab combined with bevacizumab (T+A). In response to the clinical situation where approximately half of uHCC patients do not respond to the standard T+A therapy and traditional invasive biopsy is unable to fully reflect the heterogeneity of the tumor microenvironment, this study plans to retrospectively collect the data of 400 patients who met the inclusion and exclusion criteria from January 2020 to November 2025. The study will systematically summarize multi-dimensional data such as enhanced CT images within one month before treatment, baseline characteristics, serum markers, liver disease factors, and tumor stage. By integrating these clinical features with deep learning imageomics features extracted from images, the research team is dedicated to constructing and validating a safe, non-invasive, and reproducible prediction model, with the aim of achieving precise identification of the benefit population before implementing immunotherapy combined with anti-angiogenic treatment, and providing a powerful intelligent tool support for optimizing clinical treatment decisions and improving patient survival prognosis.

Participants needed: 400
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Mar 27, 2026
Eligibility criteria

(i) Clinical or pathological diagnosis of HCC; [+2]

(i) Lack of key clinical data (laboratory test results), or lack of enhanced CT... [+4]

Status: Recruiting

SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety

Advanced liver and gallbladder malignancies (including liver cancer, cholangiocarcinoma and gallbladder cancer) are a type of disease that is difficult to treat, and most patients have a short survival period. In recent years, immunotherapy (such as PD-1/PD-L1 inhibitors) has brought new hope to these patients, but still only a small number of patients can benefit. Research has found that approximately 40% of patients with liver and gallbladder tumors have symptoms of depression and anxiety, which not only affect their quality of life but may also reduce the therapeutic effect by influencing immune function. Fluoxetine is a commonly used antidepressant. The latest research shows that in addition to improving mood, it may also enhance the anti-tumor effect of immunotherapy. This study aims to explore whether fluoxetine combined with immunotherapy can better control tumors than immunotherapy alone, prolong the survival period of patients, and at the same time improve the depressive and anxious symptoms and quality of life of patients.

Participants needed: 240
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Mar 24, 2026Locations: 1
Eligibility criteria

Age: 18 to 80 years old, both male and female are acceptable. [+10]

Those with uncorrectable coagulation dysfunction and a distinct bleeding tendenc... [+9]

Status: Not yet recruiting

The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities

This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. This study plans to enroll 134 patients with hepatocellular carcinoma who are scheduled to receive standard ICI treatment. This study will adopt the 2023 CSCO Guidelines for the Management of Immune checkpoint inhibitor-related toxicity as the main assessment criterion, and take the incidence and severity of irAEs as the main observation indicators to evaluate the effectiveness of ondansetron in reducing the toxicity related to immune checkpoint inhibitor treatment in patients with hepatocellular carcinoma.

Participants needed: 134
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Mar 11, 2026
Eligibility criteria

Age: 18 to 80 years old, both male and female are acceptable. [+5]

Those who have received treatment with ondansetron within 14 days; [+8]

Status: Not yet recruiting

Clinical Study of CBG131 CAR-T Cell Injection for the Treatment of CLDN18.2-Positive Advanced Gastric and Pancreatic Cancer

The goal of this clinical trial is to learn if CBG131 works to treat advanced gastric cancer or pancreatic cancer in adults whose tumors are CLDN18.2-positive. It will also learn about the safety of CBG131 and find the best dose to use. The main questions it aims to answer are: Is CBG131 safe, and what medical problems do participants have when receiving it? Does CBG131 shrink tumors in participants with CLDN18.2-positive cancers? How long do the CAR-T cells stay and work in the body? Researchers will test different doses of CBG131 to see which dose is safest and most effective. This is an early-stage trial, so there is no placebo group-everyone who joins will receive the actual treatment. Participants will: Have their blood cells collected through a procedure called leukapheresis (so the CAR-T cells can be made). Receive chemotherapy for 3 days to prepare their body for the CAR-T cells Get a single infusion of CBG131 CAR-T cells through an IV. Visit the clinic frequently for the first month, then regularly for 2 years for checkups, blood tests, and tumor assessments. Keep track of their symptoms and any side effects they experience.

Participants needed: 18
Trial details
Phase: Early Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Feb 6, 2026Locations: 1
Eligibility criteria

Age 18-70 years (inclusive) at the time of informed consent; sex unrestricted. [+6]

Pregnant or lactating women. [+25]

Status: Recruiting

A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer

In a single-center, prospective, phase II study (ClinicalTrials registration number: \[to be filled in\]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy for MSS-type mid-low locally advanced rectal cancer, patients with mid-low MSS-type locally advanced rectal adenocarcinoma were enrolled. They received short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy. It is anticipated that 30 subjects with locally advanced rectal cancer will be enrolled between September 2025 and September 2027. This phase II exploratory study targets patients with locally advanced mid-low MSS/pMMR rectal cancer. It employs short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy, aiming to clarify the efficacy and safety of this new combined radiotherapy, chemotherapy, targeted therapy, and immunotherapy approach, while also assessing the rectal/anal preservation rate and quality of life of patients. After neoadjuvant therapy, patients will undergo imaging and endoscopic evaluations to determine subsequent treatment strategies. Radical surgical resection will be performed on patients after neoadjuvant immunotherapy, followed by further analysis of the pathological complete response (pCR) rate. The primary study endpoint is the pCR rate, and secondary study endpoints include the objective response rate, organ preservation rate, 3-year disease-free survival (DFS), 3-year overall survival (OS), incidence of adverse events, and quality of life scores (EORTC QLQ-C30, EORTC QLQ-CR29, Wexner).

Participants needed: 30
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Jan 16, 2026Locations: 1
Eligibility criteria

Patients who have a desire to preserve the anus and are willing to receive the e... [+4]

In addition to a confirmed diagnosis of rectal cancer, there is a current or pas... [+5]

Status: Not yet recruiting

Intelligent Precision Knee Preservation System for Knee Osteoarthritis

The goal of this clinical trial is to verify whether the "dynamic dual-mode alignment optimization + intelligent precision knee-preserving system" (integrating static/kinematic target alignment, CT-based preoperative three-dimensional \[3D\] planning, 3D-printed guide plates, and intraoperative augmented reality \[AR\] real-time feedback) achieves a greater relative reduction in peak knee adduction moment (KAM) at 12 months postoperatively, while maintaining or improving knee clinical function and without increasing perioperative or long-term complication rates, compared with traditional knee-preserving strategies. The target population is patients aged 40-70 years with knee osteoarthritis (KOA; Kellgren-Lawrence grade II-III) who require high tibial osteotomy (HTO) for unilateral medial-compartment disease with mild-to-moderate varus deformity and who meet the inclusion and exclusion criteria. The main questions are: * Can the dynamic dual-mode alignment + intelligent precision system achieve a greater relative reduction in peak KAM at 12 months postoperatively than traditional knee-preserving strategies? * Can this system improve static alignment accuracy, dynamic load parameters (e.g., KAM impulse and varus thrust), and patient-reported outcome (PRO) scores without increasing complication rates? * Can 3D-printed patient-specific instrumentation (PSI) guide plates and real-time AR feedback reduce intraoperative radiation exposure and shorten operative time compared with traditional methods? Researchers will compare: Kinematic alignment (KA), traditional mechanical alignment (MA), and dynamic dual-mode alignment (DA) to evaluate the relative performance of alignment strategies; 3D-printed PSI-guided HTO versus traditional fluoroscopy-guided HTO to assess the efficacy of PSI; and AR-assisted intraoperative adjustment versus traditional fluoroscopy-based adjustment to evaluate the precision of AR navigation. Participants will: * Complete preoperative assessments, including laboratory tests (complete blood count, biochemistry, coagulation), imaging (full-length, weight-bearing lower-limb radiographs; knee CT and/or MRI as indicated), 3D gait analysis (to measure KAM, KAM impulse, and varus thrust), and PRO assessments (KOOS, WOMAC, and Lysholm scores) * Receive assigned surgical interventions: the DA group will undergo HTO guided by dual-mode alignment plus 3D-printed PSI and intraoperative AR feedback; the MA and KA groups will undergo HTO based on traditional or kinematic alignment, respectively; the traditional HTO group will undergo surgery relying on intraoperative fluoroscopy and surgeon experience. * Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months postoperatively, including imaging to assess alignment accuracy and bone healing, gait analysis, PRO assessments, and complication monitoring. * Record medication use and rehabilitation compliance throughout the study period.

Participants needed: 150
Trial details
Age: 40-70Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Dec 16, 2025Locations: 1
Eligibility criteria

Age between 40 and 70 years; [+4]

Patients with concomitant inflammatory arthritis (e.g., rheumatoid arthritis) or... [+9]

Status: Not yet recruiting

The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.

This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach. The current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. This study compares the standard LTG with an innovative procedure called Laparoscopic Proximal Gastrectomy combined with a novel anti-reflux reconstruction (LPG-tbROSF). This new technique removes only the cancerous upper portion of the stomach, aiming to preserve digestive functions and reduce post-surgery complications like acid reflux. The main goal is to see if patients who receive the new, stomach-preserving surgery experience less body weight loss one year after the procedure compared to those who undergo the standard total gastrectomy. The research will also compare the two surgeries in terms of post-operative quality of life, nutritional status, acid reflux symptoms, safety, and long-term cancer outcomes. The study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.

Participants needed: 120
Trial details
Age: 15-75Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Dec 3, 2025
Eligibility criteria

Aged from 18 to 75 years old; [+7]

Concurrent with other active malignant tumors, or a history of other malignant t... [+12]

Status: Not yet recruiting

Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer

This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy in the neoadjuvant treatment of high-risk HR+/HER2- breast cancer patients. The study plans to enroll treatment-naïve HR+/HER2- breast cancer patients aged 18-75 with high-risk features (e.g., tumor size ≥3 cm or lymph node positivity, Ki-67 ≥20%). Eligible subjects will be randomized in a 1:1 ratio into two groups: the control group will receive neoadjuvant chemotherapy (nab-paclitaxel followed by epirubicin + cyclophosphamide) in combination with sintilimab immunotherapy; the experimental group will receive the same chemotherapy and immunotherapy regimen with the addition of stereotactic body radiotherapy (SBRT) administered early during treatment, at a prescribed dose of 8 Gy per fraction for 3 fractions, with one fraction per day. The study has dual primary endpoints: pathological complete response (pCR,) and objective response rate (ORR ). Secondary endpoints include 3-year event-free survival (EFS), incidence of adverse events (CTCAE v5.0), and postoperative cosmetic outcomes of the breast. The study design incorporates hierarchical testing to control for multiplicity, and long-term follow-up is planned to evaluate survival benefits. The study has been approved by the ethics committee, and all participants are required to provide written informed consent. The results are expected to offer a novel neoadjuvant treatment strategy for high-risk HR+/HER2- breast cancer patients and improve their therapeutic outcomes.

Participants needed: 302
Trial details
Phase: Phase 2Age: 18-75Biological sex: FemaleType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Nov 28, 2025Locations: 1
Eligibility criteria

Newly diagnosed, untreated breast cancer; [+10]

Status: Not yet recruiting

Immunodynamics-Guided Optimization of Individualized Immunochemotherapy in Advanced Driver-Negative NSCLC: A Randomized Trial

The goal of this clinical trial is to evaluate whether individualized sequencing of immunotherapy and chemotherapy based on immune dynamics can improve treatment outcomes in adults with advanced non-small cell lung cancer (NSCLC) without driver gene mutations. This study will also assess the safety and feasibility of different infusion strategies. The main questions it aims to answer are: Does optimizing the timing of PD-1 inhibitor infusion relative to chemotherapy improve the objective response rate (ORR)? Does individualized infusion sequencing enhance progression-free survival (PFS) compared to standard or fixed-delay administration? What safety concerns or immune-related adverse events occur with different infusion timing strategies? Researchers will compare three treatment strategies: Group A (Standard Concurrent Group): Immunotherapy and chemotherapy administered on the same day (D1). Group B (Fixed Delay Group): Chemotherapy on D1, followed by PD-1 inhibitor infusion on Day 3. Group C (Individualized Delay Group): Chemotherapy on D1, and PD-1 inhibitor infusion scheduled on D2-D6 based on daily immune monitoring. Participants will: Receive a PD-1 inhibitor (e.g., sintilimab, pembrolizumab, camrelizumab) combined with platinum-based chemotherapy. Attend clinic visits for regular immune monitoring, imaging assessments, and safety checks during each treatment cycle. Undergo blood tests to evaluate immune biomarkers (e.g., CD8⁺PD-1⁺ T cells, MDSC, Treg、IFN-γ、NLR、ALC、CRP) to guide individualized treatment decisions.

Participants needed: 246
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 24, 2025
Eligibility criteria

Not listed

Status: Recruiting

Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy

This is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of butylphthalide soft capsules for treating cognitive impairment in elderly patients with focal epilepsy. Study Population: 220 elderly patients (60-85 years) with focal epilepsy and mild to moderate cognitive impairment (Montreal Cognitive Assessment score 18-25). Intervention: Participants will be randomly assigned 1:1 to receive either butylphthalide soft capsules (0.2g three times daily) or matching placebo for 48 weeks, while continuing their stable anti-seizure medication regimen. Primary Outcome: Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 48 weeks. Secondary Outcomes: Changes in neuropsychological tests (Trail Making Test, Digit Span, Rey Auditory Verbal Learning Test), seizure control measures, functional status (Activities of Daily Living, Quality of Life in Epilepsy), and exploratory neurobiological markers. This study addresses an important unmet medical need, as current epilepsy treatments focus primarily on seizure control but lack effective interventions for epilepsy-associated cognitive impairment. Butylphthalide, a neuroprotective agent approved for acute ischemic stroke in China, has shown promise in other cognitive disorders and may benefit this patient population through its multiple neuroprotective mechanisms.

Participants needed: 220
Trial details
Phase: Phase 4Age: 60-85Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 25, 2025Locations: 1
Eligibility criteria

Age 60-85 years (inclusive) [+5]

Diagnosed with various types of dementia (including Alzheimer's disease, vascula... [+8]

Status: Not yet recruiting

Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study

This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with/without Ta/T1) and (2) non-CIS cohort (high-risk Ta/T1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (\~month 3), monthly maintenance continues up to 24 months or until progression/unacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression/unacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression/unacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS/HG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.

Participants needed: 106
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 24, 2025Locations: 1
Eligibility criteria

Age ≥18 years; sex: all; signed written informed consent by the participant or l... [+9]

Muscle-invasive bladder cancer (T2-T4). [+11]

Status: Not yet recruiting

Comparison of Different Surgical Approaches in Female Rectal Cancer.

Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. In male patients, Heald, Chi Pan , Wei Hongbo , and others have proposed different dissection techniques for the anterior rectal wall. Partial or complete preservation of Denonvilliers Fascia (DVF) during conventional TME (as proposed by Heald) has been shown to significantly reduce intraoperative bleeding and improve postoperative urodynamic function, urinary continence, and sexual function . However, these studies focused exclusively on male patients and did not include female subjects. In our previous research, we proposed that females do not possess an anatomical structure equivalent to the male DVF. Furthermore, compared to entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection, initiating the peritoneal incision precisely at the lowest point of the peritoneal reflection better ensures the integrity of the mesorectum and vaginal structures, reduces intraoperative bleeding, provides a more favorable operative field, and avoids damage to physiological structures while ensuring complete tumor resection, thereby promoting postoperative recovery. Thus, we concluded that this plane represents the optimal surgical dissection plane for the anterior rectal wall during TME in female patients with mid-to-low rectal cancer without anterior wall invasion. Since our prior study combined anatomical and clinical retrospective research, we have initiated a prospective multicenter randomized controlled trial to further validate these clinical findings. This study aims to demonstrate that entering the dissection plane at the lowest point of the peritoneal reflection during mid-to-low rectal cancer surgery improves prognosis in female patients, providing high-level evidence-based medical support for the adoption of this technique and establishing the optimal surgical approach for female rectal cancer patients.

Participants needed: 200
Trial details
Biological sex: FemaleType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 24, 2025
Eligibility criteria

Pathologically confirmed rectal adenocarcinoma. [+4]

Presence of severe pre-existing comorbidities (e.g., significant hepatic, renal,... [+4]

Status: Not yet recruiting

Evaluation of the Clinical Efficacy and Feasibility of Digital Foot Care Intervention Strategies With Different Intensities in the Prevention of Diabetic Foot Ulcers.

For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ulcers and easier to use.

Participants needed: 1,512
Trial details
Age: 50-80Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 22, 2025
Eligibility criteria

Age ≥ 50 years but < 80 years; [+3]

Currently has an open foot wound or an unresolved foot ulcer; [+8]

Status: Not yet recruiting

Preoperative vs Postoperative Revascularization in Coronary Heart Disease Patients Undergoing Time-Sensitive Non-Cardiac Surgery (CHRONOS-PCI)

To compare the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.

Participants needed: 140
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 16, 2025Locations: 1
Eligibility criteria

Age ≥18 years [+9]

Age >80 years [+17]

Status: Not yet recruiting

Risankizumab for Fibrostenotic Crohn's Disease Treatment

This study, titled "IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study," is conducted by researchers from the First Affiliated Hospital of Wenzhou Medical University. The primary aim of this research is to evaluate the efficacy and safety of ustekinumab, an IL-23 inhibitor, for patients with fibrostenotic Crohn's disease (CD) who have failed standard treatments. The study is a prospective, open-label, randomized controlled trial involving 260 participants across three major hospitals: the First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province, and the Second Affiliated Hospital of Wenzhou Medical University. The participants are divided into two groups: one receiving ustekinumab and the other receiving a placebo. The study is designed to assess whether ustekinumab can improve clinical outcomes and reduce fibrosis progression in patients with fibrotic CD. The study involves a comprehensive assessment of participants, including clinical history, physical examination, laboratory tests, and imaging studies. Key inclusion criteria include age between 18-80 years, confirmed diagnosis of fibrostenic CD, and failure of conventional or biological therapies. Participants are excluded if they are under 18, pregnant, breastfeeding, or have certain medical conditions that could interfere with the study. The primary endpoint of the study is a clinical-imaging composite endpoint, which includes imaging assessment of bowel wall thickness and clinical symptoms. Secondary endpoints include safety, tolerability, and various functional and quality of life indicators. The study also explores the potential of ustekinumab to modulate immune responses and fibrosis-related biomarkers. The study is expected to run from October 2025 to October 2028, with follow-up visits scheduled at regular intervals. The results will provide valuable insights into the potential of ustekinumab as a novel treatment for fibrotic CD, offering a new therapeutic option for patients who do not respond to existing treatments. This research is crucial because fibrotic CD is a severe and progressive disease with limited treatment options. Ustekinumab, by targeting the IL-23 pathway, may offer a more effective and targeted approach to manage this condition. The study's findings could significantly impact clinical practice and improve patient outcomes. For more detailed information, please refer to the study protocol document titled "IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study" dated September 2, 2025. For further inquiries, contact the principal investigators Dr. Wu Fang or Dr. Wu Xiaoli at the First Affiliated Hospital of Wenzhou Medical University.

Participants needed: 260
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 16, 2025
Eligibility criteria

Age between 18 and 80 years old, with no gender restrictions. [+8]

Age less than 18 or greater than 80 years old. [+11]

Status: Not yet recruiting

Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health

Why is this study being done? Obesity can harm men's fertility by lowering sperm quality and hormone levels, making it harder to have children. Weight loss through diet and exercise helps, but it's often hard to stick with. New medicines called GLP-1 receptor agonists, like semaglutide (Ozempic) and tirzepatide (Mounjaro), help people lose weight and improve health. Early studies suggest these drugs might also boost sperm health in obese men, but more proof is needed. This study tests if these drugs can safely improve fertility in obese men who are having trouble conceiving. What will happen in this study? This is a 48-week study at several hospitals in China. About 180 men will be randomly assigned to one of three groups: Group 1: Standard lifestyle changes, like a healthy diet and exercise, guided by experts. Group 2: Weekly injections of semaglutide, starting low and increasing as tolerated. Group 3: Weekly injections of tirzepatide, starting low and increasing as tolerated. All men will have regular check-ups, including blood tests, semen analysis, and weight measurements. We will track sperm quality, hormone levels, weight loss, and whether their partners get pregnant naturally. The study includes an 8-week adjustment period, 24 weeks of treatment, and 16 weeks of follow-up. Who can join this study? Men aged 20-45 who are married, obese (BMI 28 or higher or waist size 90 cm or more), and have been trying to have a baby for at least a year without success due to low sperm count or poor sperm movement. Their female partners must be under 40 and have no major fertility issues. Men must be willing to attend visits and provide samples. People with serious health problems, recent use of similar drugs, or other causes of infertility (like genetic issues) cannot join. How long will this study last? The full study lasts 48 weeks (about 11 months), with visits every 4-8 weeks, plus monthly phone check-ins for pregnancy updates. What are the possible benefits and risks? Benefits: If the drugs work, men may lose weight, improve sperm quality, and have a better chance of their partners getting pregnant naturally. They might also feel healthier overall. Risks: Common side effects include nausea, vomiting, or diarrhea from the drugs, which usually improve over time. Rare risks include pancreas inflammation or gallbladder issues. Lifestyle changes might cause minor injuries from exercise. All side effects will be monitored closely, and participants can quit anytime. Insurance covers any study-related harm.

Participants needed: 180
Trial details
Phase: Phase 2Age: 20-45Biological sex: MaleType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 17, 2025
Eligibility criteria

(1) Married men aged 20-45 (considering childbearing age and ensuring fertility...

(1) Other clear causes affecting male fertility: e.g., obstructive azoospermia,...

Status: Not yet recruiting

Inectolizumab With Steroid Optimization in Newly Treated NMOSD

Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) patients, while assessing its impact on EDSS score improvement during acute-phase treatment. The study will further explore treatment-related biomarkers, including dynamic changes in: immunoglobulin levels, lymphocyte subset profiles, serum AQP4-IgG titers, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NFL) levels. Study Design:This is a single-center, randomized, open-label, prospective clinical study planning to enroll 25 treatment-naïve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.

Participants needed: 25
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 8, 2025
Eligibility criteria

Patients who meet the 2015 International Consensus Diagnostic Criteria for Neuro... [+4]

Laboratory abnormalities include: (white blood cell count < 3×10⁹/L), (neutrophi... [+16]

Status: Not yet recruiting

Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study

This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.

Participants needed: 224
Trial details
Phase: Phase 4Age: 16+Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Sep 3, 2025Locations: 1
Eligibility criteria

Urine protein: creatinine ratio ≥3000mg/g (300mg/mmol) [+6]

Secondary nephrotic syndrome [+6]

Status: Recruiting

Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.

Participants needed: 40
Trial details
Age: 18-65Biological sex: FemaleType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: May 13, 2025Locations: 1
Eligibility criteria

Aged 18-65 years old with a history of sexual activity. [+5]

HR-HPV persistent infection. [+9]

Status: Not yet recruiting

LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma

A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma.

Participants needed: 35
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Mar 21, 2025
Eligibility criteria

Subjects voluntarily participate in clinical research; [+7]

Received previous therapy targeting GPRC5D targets; [+7]