Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study
NCT ID: NCT06849193
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
332 participants
OBSERVATIONAL
2025-01-31
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Systemic chemotherapy combined with immunotherapy
The electronic medical record system was used to collect patients' basic information and treatment plan information, including treatment plan, administration cycle, administration date, administration dose, frequency, number of cycles, efficacy, adverse reactions, etc.
Eligibility Criteria
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Inclusion Criteria
1. Hematological system function: Absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; international normalized ratio less than 1.7 or prothrombin time prolongation not exceeding 4 seconds.
2. Liver function: Alanine aminotransferase/aspartate aminotransferase not exceeding 5 times the upper limit of normal; total bilirubin ≤ 210 μmol/L \[≤ 2.38 mg/dL\]; albumin ≥ 28 g/L.
3. Renal function: Serum creatinine not exceeding 1.5 times the upper limit of normal.
Exclusion Criteria
* Moderate to severe ascites (ascites reaching a Child-Pugh score of 3);
* Any local treatment (including transcatheter interventional therapy, ablation therapy, internal/external radiotherapy, etc.) or surgical resection or traditional Chinese medicine within 4 weeks before the combination of systemic chemotherapy and immunotherapy;
* Incomplete data, such as incomplete laboratory test data, missing or poor-quality imaging data, or lack of prognostic information;
* Severe liver dysfunction, such as decompensated cirrhosis and other liver diseases that significantly affect bilirubin levels;
* Severe comorbidities, such as refractory hypertension (blood pressure still higher than 150/100 mm Hg after optimal drug treatment), persistent arrhythmia (CTCAE grade 2 or above), any degree of atrial fibrillation, prolonged QTc interval (more than 450 milliseconds in men and more than 470 milliseconds in women), renal insufficiency, etc.;
* Human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome;
* Pregnant or lactating women;
* Acute or chronic mental disorders (including mental disorders that affect the subject's enrollment, treatment intervention, and follow-up).
18 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
The Third Affiliated Hospital of Soochow University
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
The First Affiliated Hospital, University of Science and Technology of China
OTHER
Zhejiang Cancer Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Yunnan Cancer Hospital
OTHER
Zhongda Hospital
OTHER
Responsible Party
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Gao-jun Teng
Director of interventional and Vascular Surgery Department
Principal Investigators
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Gao-Jun Teng, M.D
Role: PRINCIPAL_INVESTIGATOR
Zhongda hospital, Southeast university, Nanjing, China
Locations
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Zhongda Hospital,
Nanjing, Jiangsu, China
Zhongda Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024040196
Identifier Type: -
Identifier Source: org_study_id
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