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

NCT06048289 | Unknown

• 1 other identifier: IRB-2020-404
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Tract Tumor; Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Identifying predictive biomarkers of immunotherapy response

  ldentifying predictive biomarkers of immunotherapy response by detecting differences in genome and transcriptome sequencing between responder and non-responder patients

  1 year

Study Arms (1)

Immunotherapy combined with chemotherapy

Other: Blood samples, tumor biopsy specimens will be collected

Interventions

Blood samples, tumor biopsy specimens will be collected OTHER

Blood samples, tumor biopsy specimens at baseline will be collected

Immunotherapy combined with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Biospecimen Retention Ying, Dr

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieer Ying, Dr

CONTACT

13858195803; jieerying@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 21, 2023
• Study Start: September 14, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)