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

University of Chinese Academy Sciences

Status: Enrolling

Conditions: Cholangiocarcinoma; Biliary Tract Tumor

Treatments: Other: Blood samples, tumor biopsy specimens will be collected

Study type: Observational

Funder types: Other

Identifiers

NCT06048289

IRB-2020-404

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Immunotherapy combined with chemotherapy

Treatment:

Other: Blood samples, tumor biopsy specimens will be collected