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

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06048289

Collaborator

(none)

150

Enrollment

Location

18.5

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Tumor Cholangiocarcinoma	Other: Blood samples, tumor biopsy specimens will be collected

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 14, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Identifying predictive biomarkers of immunotherapy response [1 year]
ldentifying predictive biomarkers of immunotherapy response by detecting differences in genome and transcriptome sequencing between responder and non-responder patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

Zhejiang Cancer Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ying Jieer, Principal Investigator, Zhejiang Cancer Hospital

ClinicalTrials.gov Identifier:

NCT06048289

Other Study ID Numbers:

IRB-2020-404

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 25, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cholangiocarcinoma

Study Results

No Results Posted as of Sep 25, 2023