Clinical trials: sponsored by Fudan University
Gastric / Gastroesophageal Junction Adenocarcinoma
A Phase II Study of Ipilimumab N01 Plus Sintilimab for MSI-H or dMMR Gastric and Gastroesophageal Junction Cancer
This is a prospective, multicenter phase II clinical study designed to evaluate the efficacy and safety of ipilimumab N01 in combination with sintilimab in patients with MSI-H/dMMR gastric or gastroesophageal junction…
- Trial name
- NCT07878221
- Testing
- Ipilimumab N01, Sintilimab
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Fudan University
Physical Functional Impairment, Cognitive Impairment
PICS-p Longitudinal Cohort Study
Children who survive critical illness may develop new or worsening problems with physical health, cognitive status, emotional well-being, and social functioning.
- Conditions
- Physical Functional Impairment, Cognitive Impairment, Psychological Distress, Impaired Social Functioning
- Trial name
- PICSpLCS (NCT07876271)
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Breast Cancer, Neoadjuvant Therapy
MAMMI-BB PET for Monitoring Response to Neoadjuvant Therapy in Breast Cancer
This prospective, single-center, open-label, single-arm study will evaluate MAMMI-BB positron emission tomography (PET) for monitoring response to neoadjuvant therapy in patients with breast cancer and baseline axillary lymph…
- Conditions
- Breast Cancer, Neoadjuvant Therapy, Axilla; Breast
- Trial name
- MAMMI-PREDICT (NCT07875244)
- Testing
- Serial MAMMI-BB PET Imaging
- Where
- China
- Volunteers
- 1,024 people
- Sponsor
- Fudan University
Emmetropization, Myopia
Focus-out Glasses on Emmetropization in Chinese Children
The purpose of this study is to characterize the effects of peripheral focous-out glasses on emmetropization in non-myopic Chinese Children Aged 6-8 Years.This is a prospective, parallel-controlled randomized trial.
- Conditions
- Emmetropization, Myopia, Hyperopia
- Trial name
- NCT05689567
- Testing
- DEFOG glasses(peripheral focus-out glasses)
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
Autism
Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder
This randomized controlled trial aims to evaluate the efficacy of a 3-month maternal interactive massage intervention in toddlers aged 18-24 months with autism spectrum disorder (ASD).
- Trial name
- IMI-ASD (NCT07876245)
- Testing
- Maternal Interactive Massage, Behavioral
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
Autism, Intervention (Training) Condition
Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder
This study evaluates the efficacy of the Companion Mind-Drawing Cooperative Game Program, a parent-mediated, home-based structured play intervention targeting social cognitive development in young children with autism spectrum…
- Conditions
- Autism, Intervention (Training) Condition, Social Cognition, Cognition Improvement
- Trial name
- PMSC-ASD (NCT07708246)
- Testing
- Companion Mind-Drawing Cooperative Game Program
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Fudan University
Influenza Vaccination
Artificial Intelligence-assisted Primary Care for Influenza Vaccination Among Chronic Patients in China (AIPC-Flu)
The goal of this clinical trial is to evaluate whether an AI-assisted primary care intervention can increase influenza vaccination uptake among patients with chronic diseases and to assess the cost-effectiveness and potential for…
- Trial name
- NCT07873255
- Testing
- AI-assisted primary care intervention
- Volunteers
- 1,300 people
- Sponsor
- Fudan University
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic GC/GEJC
The goal of this exploratory study is to evaluate the efficacy and safety of zeprumetostat in combination with retlirafusp alfa, apatinib, and chemotherapy as first-line treatment in patients with HER2-negative unresectable…
- Trial name
- NCT07874425
- Testing
- Retlirafusp alfa, zeprumetostat, apatinib
- Volunteers
- 55 people
- Sponsor
- Fudan University
Colon Rectal Cancer Adenocarcinoma, Peritoneal (Metastatic) Cancer
FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)
The goal of this clinical trial is to test whether adding targeted radiation plus cadonilimab immunotherapy to standard second-line chemo works better for adults with colorectal cancer only spread to the peritoneum, and check how…
- Conditions
- Colon Rectal Cancer Adenocarcinoma, Peritoneal (Metastatic) Cancer, Second-line Treatment, Radiation Therapy
- Trial name
- TORCH-PM02 (NCT07815834)
- Testing
- Second-Line Chemotherapy, Radiation Therapy, Cadonilimab (AK104)
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Fudan University
RSV Immunization
Artificial Intelligence-assisted Primary Care for RSV Prevention (AIPC-RSV) in China
The goal of this clinical trial is to evaluate whether an AI-assisted primary care intervention for parents can increase RSV monoclonal antibody (mAb) uptake among infants, and to assess the cost-effectiveness and potential for…
- Trial name
- NCT07856290
- Testing
- RSV AI-assisted primary care intervention
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Fudan University
Cardiovascular Syndrome, Metabolic
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
This randomized trial aims to evaluate the health-promoting effects of intermittent dietary restrictions, including intermittent low-carbohydrate diet (ILCD) and calorie restriction (ICR), in school-aged children with…
- Trial name
- NCT06500078
- Testing
- Intermittent dietary restriction, General health education
- Where
- China
- Volunteers
- 324 people
- Sponsor
- Children's Hospital of Fudan University
Mayer Rokitansky Kuster Hauser Syndrome
Vaginal Lactobacillus for Postoperative Microecology and Mucosal Repair in MRKH Syndrome
This study is aimed to evaluate the promoting effects of vaginal Lactobacillus capsule on microecological reconstruction and mucosal repair of the neovagina after biological graft vaginoplasty in patients with MRKH syndrome, …
- Trial name
- NCT07865559
- Testing
- postoperative application of vaginal Lactobacillus capsule, routine care
- Volunteers
- 32 people
- Sponsor
- Obstetrics & Gynecology Hospital of Fudan University
Peripheral Arterial Disease
Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics
Peripheral arterial disease can reduce blood flow to the legs. This study will examine how blood flow patterns in the leg arteries differ between people with peripheral arterial disease and people without the disease.
- Trial name
- NCT07860138
- Testing
- Computational Fluid Dynamics Simulation
- Where
- China
- Volunteers
- 14 people
- Sponsor
- Fudan University
Vaccination
Vaccine Knowledge, Attitudes and Practices Among Men Who Have Sex With Men: a Global Cross-sectional Study
This study aims to investigate vaccine-related knowledge, attitude, vaccine confidence and vaccine hesitancy among MSM across multiple countries and regions.
- Trial name
- VAC-M (NCT07856563)
- Testing
- No Interventions
- Volunteers
- 2,000 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer, Early Breast Cancer (EBC)
SHR-A1811 Versus Trastuzumab Plus Pertuzumab in ctDNA-Positive HER2-Positive Early Breast Cancer After Pathologic Complete Response
This investigator-initiated, single-center, randomized, open-label, phase II trial will evaluate the efficacy and safety of intensified adjuvant SHR-A1811 compared with trastuzumab plus pertuzumab in women with initially stage…
- Trial name
- NCT07856303
- Testing
- SHR-A1811, Trastuzumab, Pertuzumab
- Where
- China
- Volunteers
- 358 people
- Sponsor
- Fudan University
Breast Cancer
Dalpicilib-Enhanced vs. Standard Endocrine Therapy in ER+ HER2- Early Breast Cancer
This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph…
- Trial name
- NCT06637150
- Testing
- Dalpicilib, endocrine therapy
- Where
- China
- Volunteers
- 1,388 people
- Sponsor
- Fudan University
Intrahepatic Cholangiocarcinoma
Cryoablation Combined With Anlotinib Plus TQB2868 in Patients With Advanced Intrahepatic Cholangiocarcinoma
This study will evaluate the efficacy and safety of cryoablation combined with Anlotinib plus TQB2868 in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.
- Trial name
- CASTLE-ZS-05 (NCT07846267)
- Testing
- Anlotinib, TQB2868 Injection, cryoablation
- Where
- China
- Volunteers
- 56 people
- Sponsor
- Fudan University
Breast Cancer
CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon）
This study is a Phase III non-inferiority trial targeting a specific subset of early breast cancer patients: those with HR-positive/HER2-negative, node-negative small tumors (typically ≤2cm) but who exhibit high-risk features for…
- Trial name
- NCT07432178
- Testing
- Dalpiciclib+AI ± OFS, TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy
- Where
- China
- Volunteers
- 2,288 people
- Sponsor
- Fudan University
Hormone Receptor Positive HER-2 Negative Breast Cancer
TCb vs EC-T in High Risk ER+/HER2- Breast Cancer
This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant…
- Trial name
- NCT05901428
- Testing
- Docetaxel, Carboplatin, Epirubicin
- Where
- China
- Volunteers
- 1,736 people
- Sponsor
- Fudan University
Breast Cancer With Brain Metastasis, HER2-positive Breast Cancer
T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis
A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis
- Trial name
- THUNDER (NCT07152782)
- Testing
- Neratinib, Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 202 people
- Sponsor
- Fudan University