NCT06048289

Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy

Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors

Detailed description

Patient with unresectable advanced or metastatic biliary tract tumors will be enrolled and plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment. To explore the biomarkers, tumor tissues, acquired from puncture biopsies at baseline, will be collected and investigated by genomic panel sequencing , transcriptome sequencing, and mIHC. Meanwhile, baseline peripheral blood and feces were also collected for detection of plasma proteins, genomes, and metagenomes. Finally, the investigators will analysis and explore predictive biomarkers of immunotherapy in biliary tract tumors.

Conditions

• Biliary Tract Tumor
• Cholangiocarcinoma

Interventions

Type	Name	Description
OTHER	Blood samples, tumor biopsy specimens will be collected	Blood samples, tumor biopsy specimens at baseline will be collected

Timeline

• Start date: 2023-09-14
• Primary completion: 2024-03-31
• Completion: 2025-03-31
• First posted: 2023-09-21
• Last updated: 2023-09-25

Locations

1 site across 1 country: China