Status:
UNKNOWN
Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Biliary Tract Tumor
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
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 biom...
Eligibility Criteria
Inclusion
- 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
- Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
Key Trial Info
Start Date :
September 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06048289
Start Date
September 14 2023
End Date
March 31 2025
Last Update
September 25 2023
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022