Dynamic prediction model for patients with unresectable biliary cancer receiving chemotherapy and immunotherapy

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

This study is testing a new way to predict how well patients with advanced bile duct cancer will respond to a combination of chemotherapy and immunotherapy to help doctors decide who can safely start this treatment.

Quick facts

• Study type: Observational
• Enrollment: 332 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongda Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Nanjing, Jiangsu and 1 other locations)
• Trial ID: NCT06849193 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop a dynamic prediction model for patients with unresectable biliary malignancies undergoing systemic chemotherapy combined with immunotherapy. It will assess various factors including tumor burden profiles, liver function, health status, tumor biomarkers, and serological indicators before treatment. The goal is to stratify risk among patients to identify those who can safely initiate combination therapy, thereby optimizing treatment strategies for high-risk populations.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with confirmed unresectable biliary malignancies who are eligible for chemotherapy and immunotherapy.

Not a fit: Patients with resectable biliary malignancies or those with severe liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the most suitable patients for combination therapy, potentially improving treatment outcomes for those with unresectable biliary malignancies.

How similar studies have performed: While similar approaches have been explored, this specific dynamic prediction model for unresectable biliary malignancies is novel and has not been extensively tested.

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).

Where this trial is running

Nanjing, Jiangsu and 1 other locations

• Zhongda Hospital, — Nanjing, Jiangsu, China (Recruiting)
• Zhongda Hospital — Nanjing, Jiangsu, China (Active_not_recruiting)

Study contacts

• Principal investigator: Gao-Jun Teng, M.D — Zhongda hospital, Southeast university, Nanjing, China
• Study coordinator: Gao-Jun Teng, M.D

Conditions Unresectable Biliary Tract Cancer; Dynamic Prediction Model; Immunotherapy; immunotherapy; Dynamic prediction model; systemic chemotherapy