Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study

Launched by ZHONGDA HOSPITAL · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to predict how well patients with advanced bile duct cancer (which cannot be surgically removed) might respond to a combination of chemotherapy and immunotherapy. Researchers aim to gather information about the tumor's characteristics and the patient's overall health to create a model that helps doctors identify which patients are most likely to benefit from this combined treatment. The goal is to make sure that high-risk patients receive safe and appropriate care.

To participate in this study, patients must be at least 18 years old, have a confirmed diagnosis of bile duct cancer, and have certain liver and blood test results that indicate they’re stable enough for treatment. Patients who have other serious health issues or have recently undergone specific treatments may not be eligible. Those who join the trial can expect to undergo regular health assessments and provide information about their condition, which will help in refining the treatment approach for future patients. This study is currently recruiting participants, and it is open to both men and women.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 1. Confirmed by histopathological diagnosis and/or clinical diagnosis (typical imaging features, clinical manifestations, laboratory examination, etc.) as biliary malignancy (Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Biliary malignancy (2024)); 2. Based on unresectable malignant tumor in the diagnosis of biliary and in patients undergoing chemotherapy with immunosuppressant therapy system; 3. The liver function class for Child - Pugh, A or B; 4. More than 18 years of age, gender not limited; 5. Expected survival time for 3 months or more; 6. ECOG PS score 2 or less; 7. Meet the following laboratory test parameters:
• • 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:
• • Malignant tumors other than BTC;
• • 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).