Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy
NCT ID: NCT06048289
Last Updated: 2023-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
150 participants
OBSERVATIONAL
2023-09-14
2025-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exploratory Study on the Therapeutic Effect Prediction Model of Advanced BTC Immunotherapy
NCT06074029
A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC
NCT04004234
Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer
NCT04945200
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
NCT01462903
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
NCT06043466
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immunotherapy combined with chemotherapy
Blood samples, tumor biopsy specimens will be collected
Blood samples, tumor biopsy specimens at baseline will be collected
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood samples, tumor biopsy specimens will be collected
Blood samples, tumor biopsy specimens at baseline will be collected
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma);
3. Confirmed as adenocarcinoma by histology;
4. 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);
5. At least one measurable lesion according to RECIST 1.1 standard;
6. Plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment;
7. Sign informed consent, has good compliance and can cooperate with follow-up.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhejiang Cancer Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ying Jieer
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Biospecimen Retention Ying, Dr
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-2020-404
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.