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

NCT06849193 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 332

Last updated 2025-02-27

No results posted yet for this study

Summary

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

  • Unresectable Biliary Tract Cancer
  • Dynamic Prediction Model
  • Immunotherapy

Interventions

DRUG

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.

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • The Third Affiliated Hospital of Soochow University

    collaborator OTHER

  • Jiangsu Cancer Institute & Hospital

    collaborator OTHER

  • The First Affiliated Hospital, University of Science and Technology of China

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Yunnan Cancer Hospital

    collaborator OTHER

  • Zhongda Hospital

    lead OTHER

Principal Investigators

  • Gao-Jun Teng, M.D · Zhongda hospital, Southeast university, Nanjing, China

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-03-31
Completion
2026-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06849193 on ClinicalTrials.gov