Clinical trials: sponsored by Fudan University
Breast Cancer
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Multiple trials confirm systemic T-DXd efficacy in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs.
- Trial name
- INOVATE (NCT07134153)
- Testing
- T-DXd
- Where
- 2 sites in China
- Volunteers
- 139 people
- Sponsor
- Fudan University
Influenza Vaccination
Family Physician Nudges for Influenza Vaccination Among Older Adults
The goal of this clinical trial is to learn if a family-physician nudge intervention works to improve influenza vaccination among adults aged 65 years and older in China.
- Trial name
- NCT07864597
- Testing
- Family Physician Influenza Vaccination Nudge
- Volunteers
- 3,060 people, healthy volunteers welcome
- Sponsor
- Fudan University
Triple-negative Breast Cancer
Reverse Triple Negative Immune Resistant Breast Cancer
This is a Phase II, open-label, nine-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, efavirenz, SHR 1811, SHR 2102, mecapegfilgrastim, theophylline, mifepristone) with…
- Trial name
- Renaissance (NCT05076682)
- Testing
- Choline, anti-PD-1 antibody and chemotherapy, Sodium Cromoglicate
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Fudan University
Endometrial Neoplasm Malignant Stage I
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA/MPA) alone as…
- Trial name
- NCT05247268
- Testing
- Megestrol Acetate 160 MG Oral Tablet, Medroxyprogesterone Acetate 500 MG, Triprorelin Acetate
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Fudan University
Peritoneal Mesothelioma, First-line Therapy
First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma
This is a prospective, multicenter, single-arm, Phase II clinical study evaluating the efficacy and safety of sintilimab in combination with ipilimumab N01 and bevacizumab as first-line treatment in patients with unresectable…
- Trial name
- PeM (NCT07893340)
- Testing
- Sintilimab, Ipilimumab N01, Bevacizumab
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Fudan University
Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation
G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous…
- Conditions
- Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation, Hemato-oncologic Patients
- Trial name
- NCT07362810
- Testing
- G-CSF+IL-11, G-CSF Granulocyte-Colony Stimulating Factor
- Where
- 7 sites in China
- Volunteers
- 224 people
- Sponsor
- Fudan University
Metastatic Colorectal Cancer
Becotatug Vedotin Plus Pucotenlimab for Metastatic Colorectal Cancer
The BECOME trial will study whether becotatug vedotin combined with pucotenlimab can shrink tumors and how safe this treatment is in adults with colorectal cancer that has returned or spread after at least two prior lines of…
- Trial name
- NCT07884188
- Testing
- Becotatug Vedotin (MRG003), Pucotenlimab
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Fudan University
Breast Cancer, TNBC - Triple-Negative Breast Cancer
Thymalfasin Combined With Chemotherapy and Immunotherapy in TNBC Neoadjuvant Treatment
This is a prospective, open-label, single-center, phase II, randomized controlled clinical trial involving patients with triple-negative breast cancer who meet the criteria for neoadjuvant chemotherapy (T > 2 cm, N+).
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, Immunotherapy
- Trial name
- NCT07884201
- Testing
- Thymalfasin
- Volunteers
- 572 people
- Sponsor
- Fudan University
Microsatellite Stable Metastatic Colorectal Cancer
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1，Chemotherapy and Target Therapy for Metastatic Colorectal Cancer
To improve the survival in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) by loco-regional therapy with personalized ultra-fractionated radiation plus immunotherpy.
- Trial name
- iPULSAR-CRC (NCT06841159)
- Testing
- Ultra-fractionated radiation therapy, Sintilimab, Standard systemic therapy
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Fudan University
Gastric Adenocarcinoma, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Efficacy of Tirellizumab Combined With Oral, Intravenous and Abdominal Chemotherapy in Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
For peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma (cT3-4NanyM1), PD-1 antibody combined with chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) can downstage tumor stage, increase the…
- Conditions
- Gastric Adenocarcinoma, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma, Peritoneal Metastasis
- Trial name
- NCT06914687
- Testing
- Tislelizumab, S-1, Oxaliplatin
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fudan University
Locally Advanced Colon Cancer, pMMR
Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS
Locally advanced colon cancer, particularly T4 disease or colon cancer with bulky nodes, carries a poor prognosis and limited efficacy with neoadjuvant chemotherapy.
- Trial name
- TORCH-C2 (NCT07877597)
- Testing
- short-course radiotherapy, Serplulimab, CapOx(Capecitabine+ Oxaliplatin)
- Where
- China
- Volunteers
- 480 people
- Sponsor
- 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
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
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
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
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
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