MedTrace Logo

Exploratory Study on the Therapeutic Effect Prediction Model of Advanced BTC Immunotherapy

NCT06074029 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-08

No results posted yet for this study

Summary

1. Establish a predictive model for the efficacy of immune checkpoint inhibitors (ICI) in Chinese patients with biliary tract cancers. By analyzing the dynamic changes of circulating tumor DNA (ctDNA) and other clinical and pathological features before and after ICI treatment in a cohort of patients with biliary tract tumors, a predictive model can be established to evaluate the efficacy of ICI treatment in the early stages or even before treatment, serving as a reliable tool for selecting patients who are likely to benefit from ICI treatment.
2. Investigate the clinical features of populations that benefit from different immune combination therapies. By comparing the differences and enrichment of mutations between patients receiving different treatment regimens, and if patients have sufficient pre-treatment tissue, further comparisons of differentially expressed genes and pathways may be made.

Conditions

  • Biliary Tract Cancer
  • Immune Checkpoint Inhibitor
  • Predictive Cancer Model

Interventions

DRUG

Immune Checkpoint Inhibitors

Immune Checkpoint Inhibitors including Durvalumab, Pembrolizumab and Toripalimab

Sponsors & Collaborators

  • Geneplus-Beijing Co. Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-12-30
Completion
2024-08-01

Countries

  • China

Study Locations

More Related Trials

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 NCT06074029 on ClinicalTrials.gov