Clinical trials: open to volunteers, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University
Radiation Induced Proctitis
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
The goal of this single-arm trial is to learn if Fecal Microbiota Transplantation (FMT) works to treat hemorrhagic radiation-induced proctopathy.
- Trial name
- NCT06776029
- Testing
- Fecal Microbiota Transplantation Capsule
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Rectal Cancer, Neoadjuvant Therapies
Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)
Most rectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) and respond poorly to PD-1 inhibitors. Radiotherapy can enhance tumor antigen release and improve responsiveness to PD-1 blockade in…
- Conditions
- Rectal Cancer, Neoadjuvant Therapies, Immune Checkpoint Therapy, Radiotherapy
- Trial name
- NCT06958432
- Testing
- Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor, Conventional Radiotherapy plus Chemotherapy
- Where
- China
- Volunteers
- 430 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Crohn Disease (CD), Intestinal Stricture
Endoscopic Stricturotomy Versus Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease
This multicenter, open-label, randomized controlled trial aims to compare the safety and immediate effectiveness of endoscopic stricturotomy (ES) and endoscopic balloon dilation (EBD) for the treatment of small bowel fibrotic…
- Conditions
- Crohn Disease (CD), Intestinal Stricture, Intestinal Fibrosis
- Trial name
- NCT07833332
- Testing
- Endoscopic Stricturotomy, Endoscopic Balloon Dilation
- Where
- China
- Volunteers
- 244 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Crohn Disease (CD), Postoperative Recurrence and Metastasis
Prediction of Postoperative Recurrence in Crohn's Disease
This multicenter prospective observational cohort study aims to develop and validate a multimodal prediction model for postoperative recurrence in patients with Crohn's disease.
- Trial name
- NCT07824791
- Testing
- Intestinal Resection, Biospecimen Collection
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Phase 2 Study
mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer
Neoadjuvant mFOLFOXIRI plus bevacizumab may achieve tumor shrinkage and reduce micrometastases, offering a radiotherapy-free organ-preservation alternative for locally advanced rectal cancer.
- Trial name
- FOBEAR-ii (NCT07817888)
- Testing
- FOLFOXIRI + Bevacizumab
- Volunteers
- 119 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
ESCC
Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma：A Prospective Single-Arm, Phase II Study
This prospective, single-arm phase II study will evaluate the efficacy and safety of lymphatic-drainage-sparing short-course radiotherapy combined with camrelizumab and nab-paclitaxel/carboplatin as neoadjuvant treatment for…
- Trial name
- NeoSCRTIC-01 (NCT07808853)
- Testing
- Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Radiotherapy, Radiation-Induced Complications
A Prospective, Single-Arm Clinical Study of a Dietary Supplement for the Prevention of Acute Radiation-Induced Rectal Injury During Neoadjuvant Chemoradiotherapy for Rectal Cancer
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as a dietary supplement for preventing acute radiation-induced rectal injury (ARII).
- Trial name
- NCT07802002
- Testing
- Tributyrin
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Radiotherapy, Radiation Proctitis
Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
This is a prospective, observational study aimed at exploring the associations between the clinical classification of chronic radiation enteropathy and prognosis.
- Conditions
- Radiotherapy, Radiation Proctitis, Radiation Enteritis
- Trial name
- NCT07378631
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Rectal Adenocarcinoma, High-Risk Cancer
NCT + PD1 + Ketogenic Diet and/or Vitamin C for LARC
To explore the efficacy and safety of adding a ketogenic diet and/or high-dose intravenous vitamin C to neoadjuvant short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with serplulimab in patients with locally…
- Conditions
- Rectal Adenocarcinoma, High-Risk Cancer, MSS
- Trial name
- CRI-KEV (NCT07765667)
- Testing
- Short-Course Radiotherapy, PD-1 monoclonal antibody, mFOLFOX6 regimen
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Radiotherapy, Radiation Proctitis
Dietary Supplements to Treat Radiation-Induced Rectal Injury
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI).
- Trial name
- NCT06776016
- Testing
- Butyrate
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Chemotherapy Effect
Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer
This study focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction. It evaluates the perioperative oxaliplatin with S-1 (SOX) combined H.
- Trial name
- NCT06510010
- Testing
- Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate), Oxaliplatin With S-1 （SOX）
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Crohn's Disease
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
The goal of this observational study is to evaluate the effectiveness and safety of exclusive enteral nutrition (EEN) in adults with active Crohn's disease (CD), particularly in patients with complicated disease such as…
- Trial name
- EEN-CD (NCT07504510)
- Testing
- Exclusive Enteral Nutrition
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Ulcerative Colitis (UC)
Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
This multicenter retrospective comparative cohort study evaluated the real-world effectiveness and safety of upadacitinib plus vedolizumab compared with upadacitinib monotherapy during 8-week induction in adults with…
- Trial name
- NCT07442045
- Testing
- Upadacitinib, Vedolizumab
- Where
- 6 sites in China
- Volunteers
- 150 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel…
- Conditions
- Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
- Trial name
- NCT04840264
- Testing
- Docetaxel, Oxaliplatin, Fluorouracil
- Where
- China
- Volunteers
- 79 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Crohn Disease
Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease
Crohn's disease (CD) is a chronic inflammatory bowel disease with high recurrence and surgical rates. Mucosal healing is a key therapeutic goal, yet current anti-TNF-α biologics achieve only about 30% mucosal healing.
- Trial name
- CDED (NCT07344428)
- Testing
- Crohn's Disease Exclusion Diet
- Where
- China
- Volunteers
- 185 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Crohn's Disease
Real-World Study of IL-23 Inhibitors in Active Crohn's Disease
The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice.
- Trial name
- NCT07545317
- Testing
- IL-23 inhibitor, TNF inhibitors
- Where
- China
- Volunteers
- 665 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Crohn Disease (CD), Ulcerative Colitis (UC)
IBD Biomarker Discovery and Validation Platform
The goal of this observational study is to establish a multicenter prospective clinical and biospecimen platform for biomarker discovery and validation in inflammatory bowel disease, including Crohn's disease and ulcerative…
- Conditions
- Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Diseases (IBD)
- Trial name
- IBD-BIOP (NCT07686406)
- Where
- 2 sites in China
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Rectal Squamous Cell Carcinoma
Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime.
- Trial name
- NCT06364384
- Testing
- PD-1 and CRT
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Rectal Adenocarcinoma, High-Risk Cancer
SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC
To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for…
- Conditions
- Rectal Adenocarcinoma, High-Risk Cancer, MSS
- Trial name
- CRITⅡ (NCT07549399)
- Testing
- Short-Course Radiotherapy, PD-1 monoclonal antibody, mFOLFOX6 regimen
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Rectal Adenocarcinoma, High-risk Locally Advanced
A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)
This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk…
- Conditions
- Rectal Adenocarcinoma, High-risk Locally Advanced, Short-course Radiotherapy (SCRT), Immunotherapy
- Trial name
- STAR (NCT07669220)
- Testing
- Short-course Radiotherapy, SCRT, Toripalimab
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University