Clinical trials: sponsored by Fudan University
Cancer
The FuSion Program: A Prospective and Multicenter Cohort Study of Pan-Cancer Screening in Chinese Population
The integrative study by Fudan and Singlera for cancer early detection(The FuSion Program ) will evaluate sensitivity,specificity and positive/negative predictive value of the screening model jointly developed by FuDan University…
- Trial name
- NCT05159544
- Where
- 12 sites in China
- Volunteers
- 60,000 people, healthy volunteers welcome
- Sponsor
- Singlera Genomics Inc.
Neutropenia, Breast Cancer
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide.
- Trial name
- NCT02527746
- Testing
- F-627, EC regimen
- Volunteers
- 18 people
- Sponsor
- EVIVE Biotechnology
Advanced Malignancies
Phase I Study of XZ120 in Malignant Tumors
This research includes two parts: the first part of the patients with late malignant tumor monotherapy study, at the beginning of the second part in treat DLBCL and research on combination therapy in patients with advanced breast…
- Trial name
- NCT06206915
- Testing
- XZ120 injection
- Volunteers
- 123 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Tumor
A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.
The main purpose of To evaluate the safety, tolerability and pharmacokinetic characteristics of SIBP-03（Recombinant anti-HER3 humanized monoclonal antibody injection）. A secondary purpose Assess the immunogenicity of SIBP-03.
- Trial name
- NCT05203601
- Testing
- SIBP-03
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Shanghai Institute Of Biological Products
HER2-positive Early Breast Cancer
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel…
- Trial name
- NCT03989037
- Testing
- SIBP-01, Herceptin, Docetaxel
- Where
- China
- Volunteers
- 580 people
- Sponsor
- Shanghai Institute Of Biological Products
Laryngectomy; Status
Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy
The objective of the study is to evaluate the clinical safety and efficacy of voice prosthesis for voice reconstruction after total laryngectomy in China.
- Trial name
- NCT05482815
- Testing
- Provox Vega Voice prosthesis
- Where
- 3 sites in China
- Volunteers
- 80 people
- Sponsor
- Atos Medical AB
Glioma, Malignant, Computer-Assisted
Radiomics-Based Visualization and Quantitative Validation of IDH1 Heterogeneity in Gliomas
The goal of this clinical trail is to non-invasively visualise and quantitatively validate an radiomics model of genetic heterogeneity in adult patients with diffuse glioma to help clinicians better guide surgical resection and…
- Trial name
- NCT05969691
- Testing
- Validation of IDH1 mutations from the radiomics model
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Mingge LLC
Myopia, Progressive
Clinical Study of Light Therapy to Control Myopia Progression in Children
Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades.
- Trial name
- NCT05761379
- Testing
- Photobiomodualtion Therapy, Single vision spectacles for correction myopia
- Where
- China
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Beijing Airdoc Technology Co., Ltd.
Hyperkalemia, Hypokalemia
Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels
China National Heart Failure Registration Study (CN-HF) is a nationwide, hospital-based, multicentre, prospective registry study sponsored by Ministry of Science and Technology of the People's Republic of China.
- Conditions
- Hyperkalemia, Hypokalemia, Heart Failure
- Trial name
- SPLENDID (NCT05184998)
- Where
- China
- Volunteers
- 6,950 people
- Sponsor
- AstraZeneca
X-Linked Retinitis Pigmentosa
Gene Therapy for Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa
A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).
- Trial name
- NCT05874310
- Testing
- FT-002
- Where
- 2 sites in China
- Volunteers
- 18 people
- Sponsor
- Frontera Therapeutics
Head and Neck Cancer, Esophageal Cancer
A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer
9 participants are expected to be enrolled for this open，single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory head and neck cancer.
- Conditions
- Head and Neck Cancer, Esophageal Cancer, Otorhinolaryngologic Neoplasms, Ear Cancer
- Trial name
- NCT05830240
- Testing
- Recombinant oncolytic herpes simplex virus type 1 (R130)
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Shanghai Yunying Medical Technology
Glioma, Malignant, Computer-Assisted Surgery
Intraoperative Rapid Diagnosis of Glioma Based on Fusion of Magnetic Resonance and Ultrasound Imaging
The aim of this observational study is to enable rapid diagnosis of molecular biomarkers in patients during surgery by medical imaging and artificial intelligence models, to help clinicians with strategies to maximize safe…
- Trial name
- NCT05656053
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Mingge LLC
Glioma, Primary Brain Tumor
MRI-based Computer Aided Diagnosis Software (V1) for Glioma
The goal of this multi-center clinical trial is to evaluate the effectiveness of MRI-based computer-aided diagnosis software (V1) for glioma segmentation, gene prediction, and tumor grading.
- Trial name
- NCT05739500
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Mingge LLC
Hepatocellular Carcinoma (HCC)
The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects
The primary efficacy index of this study is to compare the OS of the two groups.
- Trial name
- NCT03236649
- Testing
- Icaritin, Sorafenib Tosylate Tablets
- Where
- 26 sites in China
- Volunteers
- 89 people
- Sponsor
- Beijing Shenogen Biomedical Co., Ltd
Viral Keratitis, Blindness Eye
Safety and Efficacy of CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy to Treat Refractory Viral Keratitis
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single escalating doses of BD111 CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy administered via corneal injection in participants with…
- Conditions
- Viral Keratitis, Blindness Eye, Herpes Simplex Virus Infection, Cornea
- Trial name
- NCT04560790
- Testing
- BD111 Adult single group Dose
- Where
- China
- Volunteers
- 3 people
- Sponsor
- Shanghai BDgene Co., Ltd.
Colon Cancer, Organoids
Cetuximab Sensitivity Correlation Between Patient-Derived Organoids and Clinical Response in Colon Cancer Patients.
Eighty patients with RAS/RAF wild-type metastatic right colon cancer will be enrolled and undergo a fresh biopsy of tumor lesion before the standard treatment of chemotherapy.
- Conditions
- Colon Cancer, Organoids, Metastatic Cancer
- Trial name
- NCT04906733
- Testing
- Tumor biopsy
- Where
- China
- Volunteers
- 80 people
- Sponsor
- D1 Medical Technology (Shanghai) Co., Ltd, China
Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell acute lymphoblastic leukemia or lymphoma, who…
- Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
- Trial name
- NCT03265106
- Testing
- BinD19
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen BinDeBio Ltd.
Advanced HBV-Related Hepatocellular Carcinoma (HCC)
The Phase III Study of Icaritin Versus HUACHANSU PIAN in Hepatocellular Carcinoma Subjects
The enriched HBV-related advanced HCC patient population (composite biomarker score ≥ 2) and overall survival (OS) were compared between the two groups.
- Trial name
- NCT03236636
- Testing
- Icaritin, HUACHANSU PIAN
- Where
- 28 sites in China
- Volunteers
- 312 people
- Sponsor
- Beijing Shenogen Biomedical Co., Ltd
Chemotherapy-induced Peripheral Neuropathy, Colorectal Cancer
Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial
This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial of Yiqi Wenjing prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy.
- Trial name
- YWPPEOPNCT (NCT04690283)
- Testing
- Mimetic granules of Yiqi-Wenjing prescriptions, Huangqi-Guizhi-Wuwu granules, Danggui-Sini granules
- Volunteers
- 360 people
- Sponsor
- Nanjing NingQi Medicine Science and Technology Co., Ltd.
Lymphoma, Leukemia
Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies
The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors.
- Trial name
- NCT04497701
- Testing
- PEG-rhG-CSF group, rhG-CSF group
- Where
- China
- Volunteers
- 139 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.