Actively Recruiting
Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study
Led by Zhongda Hospital · Updated on 2025-02-27
332
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
Sponsors
Z
Zhongda Hospital
Lead Sponsor
E
Eastern Hepatobiliary Surgery Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study focused on the longitudinal tumor burden profile (tumor macro features, histopathological types and imaging features, etc.), liver function, health status, tumor biomarkers, and serological indicators of patients with unresectable biliary malignancies before chemotherapy combined with immunotherapy to build a dynamic prediction model. Based on this model, risk stratification of BTC patients was realized to explore which specific populations could safely initiate combination therapy. By constructing a risk stratification model, it can help clinicians to screen the best treatment population and provide a basis for safe treatment of high-risk patients.
CONDITIONS
Official Title
Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed biliary malignancy by pathology or clinical diagnosis according to CSCO guidelines
- Diagnosed with unresectable biliary malignancy and undergoing chemotherapy combined with immunotherapy
- Liver function classified as Child-Pugh class A or B
- Age 18 years or older, any gender
- Expected survival time of 3 months or more
- ECOG Performance Status score of 2 or less
- Laboratory results meeting specified blood, liver, and kidney function requirements: neutrophil count 6 1.0�d710�b9/L; platelet count 6 50�d710�b9/L; hemoglobin 6 90 g/L; INR less than 1.7 or prothrombin time prolongation within 4 seconds; ALT/AST not exceeding 5 times the upper normal limit; total bilirubin 4 210 bcmol/L; albumin 6 28 g/L; serum creatinine not exceeding 1.5 times the upper normal limit
You will not qualify if you...
- Presence of malignant tumors other than biliary tract cancer
- Moderate to severe ascites reaching Child-Pugh score of 3
- Any local cancer treatment or surgery within 4 weeks before starting systemic chemotherapy and immunotherapy
- Incomplete or poor-quality laboratory, imaging, or prognostic data
- Severe liver dysfunction such as decompensated cirrhosis
- Severe comorbid conditions including refractory hypertension, persistent arrhythmia grade 2 or above, any atrial fibrillation, prolonged QTc interval, or renal insufficiency
- HIV infection or AIDS
- Pregnant or breastfeeding women
- Acute or chronic mental disorders affecting participation, treatment, or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Zhongda Hospital,
Nanjing, Jiangsu, China
Actively Recruiting
2
Zhongda Hospital
Nanjing, Jiangsu, China
Active, Not Recruiting
Research Team
G
Gao-Jun Teng, M.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here