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

September 22, 2023 updated by: Ying Jieer, Zhejiang Cancer Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a pathological diagnosis of biliary tract tumors who have agreed to receive first-line PD-1/PD-L1 inhibitors combined with chemotherapy

Description

Inclusion Criteria:

  1. Over 18 years old;
  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:

  1. Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Immunotherapy combined with chemotherapy
Other: Blood samples, tumor biopsy specimens will be collected
Blood samples, tumor biopsy specimens at baseline will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Biospecimen Retention Ying, Dr, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 14, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

September 10, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2020-404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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