An observational study in Biliary Stricture, Bile Duct Cancer and Pancreas Cancer, sponsored by Peking University Third Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Peking University Third Hospital · Observational
Among 24 studies in Bile Duct Neoplasms with a site in China — 12 open to participants now, 13 under way, 1 of them phase 3. Bile Duct Neoplasms · China.
Among the 24 studies in Bile Duct Neoplasms with a site in China, this one is one of 3 that started in 2024, is one of 5 observational ones, reaches primary completion later than 2 of the 12 other live ones, and was the 19th registered.
254 studies on the registry are indexed under Bile Duct Neoplasms; 44 are open to participants now.
Browse Bile Duct Neoplasms studies →12 of the 24 studies in Bile Duct Neoplasms with a site in China are open now. Recruiting first, the newest first:
Jinbo Yue · Sites in China
Ages 18–75
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 18–75
RenJi Hospital · Sites in China
Ages 18–75
UTC Therapeutics Inc. · Sites in China
Ages 18–70
Air Force Military Medical University, China · Sites in China
Ages 18–90 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 36 Bile Duct Neoplasms studies recruiting now, 21 (58%) set no upper age limit and 6 (17%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
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24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 4 · Phase 4 1
First in 2010; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 99 is below the median of 216 across 42 observational studies indexed under Bile Duct Neoplasms.
Median enrollment 100 across the 19 interventional studies, 99 across the 5 observational. Of the 4 that completed or were terminated, 3 (75%) have results posted.
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8 of 24 have an industry lead sponsor. The 10 most frequent:
Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
Peking University Third Hospital has 1 study filed under Bile Duct Neoplasms — fewer than ten, so there is no comparison to draw.
6 of the studies in Bile Duct Neoplasms with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07036185Shanghai Bao Pharmaceuticals Co., Ltd.A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors | 2026-12-31 |
| NCT07025174First Affiliated Hospital of Zhejiang UniversitySequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer | 2026-12-31 |
| NCT06043466Chongqing Precision Biotech Co., LtdA Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors | 2026-12-31 |
| NCT07030140Jinbo YuePhase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma | 2027-07-01 |
| NCT05150691DualityBio Inc.A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors | 2027-08 |
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Among the 24 studies in Bile Duct Neoplasms with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.
Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.
In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.
Patients are suspected indetermined biliary strictures
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient is diagnosed with malignant disease from biliary system
Malignant tumor is confirmed by histopathology or cytopathology. If the pathology is unclear or inaccessible, 2 gastroenterologists will finally confirm the diagnosis of the bile duct stricture after 1 year follow-up.
Time frame: in one year
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Jul 2025, 16 months after the start.
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