Clinical trials: sponsored by Fudan University
Breast Cancer
Capecitabine in Low Risk Triple Negative Breast Cancer
This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk early triple-negative breast cancer who have received adequate local treatment.
- Trial name
- Calorite (NCT06787339)
- Testing
- Capecitabine
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Fudan University
Colon Cancer, Deficient Mismatch Repair
ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer
This prospective, multicenter, single-arm phase II interventional study evaluates whether longitudinal circulating tumor DNA (ctDNA) monitoring can guide neoadjuvant immunotherapy and surgical decision-making in dMMR/MSI-H colon…
- Conditions
- Colon Cancer, Deficient Mismatch Repair, Microsatellite Instability-High (MSI-H)
- Trial name
- NCT07841236
- Testing
- PD-1 inhibitor, CTLA-4 inhibitor, ctDNA/MRD testing
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Fudan University
Diurnal Variation of Coagulation Function
Exploring the Impact of Diurnal Variation on Coagulation Function in Patients Undering Tumor Surgery
Studies have shown that compared to the evening, the platelet adhension and aggregation functions of normal individuals are stronger in the morning, reaching peak at around 8AM or 9AM.
- Trial name
- NCT07841613
- Testing
- No Biologics
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Fudan University
Breast Cancer With Brain Metastasis, HER2-low Expressing Breast Cancer
T-DXd With or Without Bevacizumab for HER2-low 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 Bevicizumab in HER2-low breast cancer with brain metastasis.
- Trial name
- THUMB (NCT07150208)
- Testing
- Bevacizumab (Bev), Trastuzumab Deruxtecan (T-DXd)
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fudan University
Advanced Breast Cancer, HR+/HER2- Breast Cancer
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer.
- Trial name
- NCT06447623
- Testing
- Apatinib, CDK4/6 Inhibitor, Aromatase inhibitor and Fulvestrant
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Fudan University
Triple -Negative Breast Cancer
Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer
RECLAIM: A Phase II, Open-Label, Single-Arm, Multicenter Clinical Trial of Cromolyn, TQB2102, and Panpulimab for Re-Challenging Immune-Refractory Triple-Negative Breast Cancer
- Trial name
- RECLAIM (NCT07419880)
- Testing
- Cromolyn, TQB2102, and Panpulimab
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Fudan University
Early-Stage Breast Cancer
1-Week Versus 3-Week PBI
This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial…
- Trial name
- NCT07832279
- Testing
- 3-week PBI, 1-week PBI
- Where
- China
- Volunteers
- 818 people
- Sponsor
- Fudan University
Non-alcoholic Steatohepatitis
Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis
The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.
- Trial name
- EASYBEinNASH (NCT03198572)
- Testing
- Lifestyle intervention, Berberine
- Where
- 6 sites in China
- Volunteers
- 89 people
- Sponsor
- Fudan University
Early Low Rectal Cancer
SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer
The study evaluates the combination of immunotherapy of PD-1/ CTLA4 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer.
- Trial name
- NCT07837362
- Testing
- Shor-course radiotherapy, PD-1/CTLA4 Antibody, Capecitabine
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Fudan University
Breast Cancer
Response-Adapted Omission of Nodal Boost In N3 Breast Cancer After Neoadjuvant Systemic Therapy
Background Clinical N3 (cN3) breast cancer represents a high-risk subgroup of locally advanced disease. After neoadjuvant systemic therapy (NST), patients who achieve a clinical complete response (cCR) in initially involved but…
- Trial name
- NCT07829848
- Testing
- standard boost, boost omission
- Where
- China
- Volunteers
- 534 people
- Sponsor
- Fudan University
Esophageal Cancer
Cola Ingestion for Esophageal Bolus Impaction
The aim of the study is to observe whether cola ingestion can improve the 24-hour remission rate of acute esophageal impaction in patients with esophageal cancer.
- Trial name
- NCT06652620
- Testing
- Cola
- Where
- 5 sites in China
- Volunteers
- 50 people
- Sponsor
- Fudan University
Breast Cancer, Implant Breast Reconstruction
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based…
- Trial name
- NCT07835139
- Testing
- ConvRT, HypoRT
- Where
- China
- Volunteers
- 534 people
- Sponsor
- Fudan University
Biliary Tract Cancer (BTC)
Cryoablation Combined With QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer.
This study will evaluate the efficacy and safety of cryoablation combined with QL1706 (iparomlimab/tuvonralimab) plus lenvatinib in patients with advanced biliary tract cancer (BTC) who have progressed after first-line treatment.
- Trial name
- CASTLE-ZS-04 (NCT07829874)
- Testing
- QL1706 (Iparomlimab/Tuvonralimab), Lenvatinib, Cryoablation
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Fudan University
Metastatic Breast Cancer
A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer (TNBC) patients.
- Trial name
- SPARK (NCT04734262)
- Testing
- Sitravatinib, Tislelizumab, Nab-paclitaxel
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Fudan University
Rectal Cancer
Neoadjuvant Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study
This open-label, multicenter, randomized controlled trial involved 196 patients with pathologically confirmed, previously untreated, resectable MSI-L or MSS/pMMR ultra-low rectal adenocarcinoma.
- Trial name
- NCT07132463
- Testing
- Long-course chemoradiotherapy, Tislelizumab combined with the CAPOX regimen, CAPOX regimen
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Fudan University
Penile Cancer
A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer
Penile cancer is a rare malignant tumor of the male genitourinary system, with 95% being squamous cell carcinoma. Due to social factors, delayed diagnosis is common, leading to a high rate of lymph node metastasis (17%-45% at…
- Trial name
- NCT07497919
- Testing
- Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Fudan University
Advanced or Metastatic Pancreatic Adenocarcinoma, Advanced or Metastatic Breast Cancer (BC)
Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer
To evaluate the clinical efficacy (objective response rate, ORR) of mass spectrometry-based absolute quantification-guided selection and matching of ADC/PDC therapy in patients with locally advanced or metastatic pancreatic…
- Trial name
- PROBE (NCT07825753)
- Testing
- Trastuzumab emtansine (T-DM1), Trastuzumab deruxtecan (T-DXd), Datopotamab deruxtecan (Dato-DXd)
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Fudan University
Colon Cancer, Nerve Preserve
The Role of Total Abdominal Autonomic Nerve Preservation During the Resection of Right/Left Colon Cancer: Prospective Clinical Trial
Preservation of pelvic autonomic nerves to retain genitourinary function without compromise of oncologic clearance of tumor has been extensively studied in rectal cancer surgery.
- Trial name
- NCT07825766
- Testing
- Abdominal autonomic nerve preserverd in the TNP arm
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Fudan University
Breast Cancer, Adjuvant Therapy
Chemotherapy Exemption in Elderly Women With Node-Positive ER+/HER2- Breast Cancer
This study is a prospective, open-label, multicenter, single-arm Phase II clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of…
- Trial name
- ELDER (NCT07826052)
- Testing
- CDK4/6 inhibitor, Endocrine Therapy (Optional)
- Volunteers
- 494 people
- Sponsor
- Fudan University
Early-Stage Breast Cancer
PBI for Low-risk Breast Cancer
This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial…
- Trial name
- NCT07814365
- Testing
- 3-week PBI, 1-week PBI
- Where
- China
- Sponsor
- Fudan University