Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Biliary Tract Tumor
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Identifying predictive biomarkers of immunotherapy response
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Ying Jieer
Principal Investigator
Zhejiang Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Over 18 years old;
- •Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma);
- •Confirmed as adenocarcinoma by histology;
- •Has not received systemic therapy in the past (patients who have not progressed within six months after the completion of neoadjuvant therapy or adjuvant therapy can be enrolled);
- •At least one measurable lesion according to RECIST 1.1 standard;
- •Plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment;
- •Sign informed consent, has good compliance and can cooperate with follow-up.
Exclusion Criteria
- •Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
Outcomes
Primary Outcomes
Identifying predictive biomarkers of immunotherapy response
Time Frame: 1 year
ldentifying predictive biomarkers of immunotherapy response by detecting differences in genome and transcriptome sequencing between responder and non-responder patients