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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: gjteng@vip.sina.com
• Phone: +86-02583272121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.