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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048289
• Other study ID #: IRB-2020-404
• Status: Recruiting
• Start date: September 14, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2023
• Source: Zhejiang Cancer Hospital
• Contact: Jieer Ying, Dr
• Phone: 13858195803
• Email: jieerying[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Tumor
• Cholangiocarcinoma

Intervention

Other:
• Blood samples, tumor biopsy specimens will be collected
Blood samples, tumor biopsy specimens at baseline will be collected

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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