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

Last updated: September 22, 2023
Sponsor: Zhejiang Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Cancer

Biliary Tract Cancer

Liver Cancer

Treatment

Blood samples, tumor biopsy specimens will be collected

Clinical Study ID

NCT06048289
IRB-2020-404
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Over 18 years old;
  2. Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, andgallbladder carcinoma);
  3. Confirmed as adenocarcinoma by histology;
  4. Has not received systemic therapy in the past (patients who have not progressed withinsix months after the completion of neoadjuvant therapy or adjuvant therapy can beenrolled);
  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-linetreatment;
  7. Sign informed consent, has good compliance and can cooperate with follow-up.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Blood samples, tumor biopsy specimens will be collected
Phase:
Study Start date:
September 14, 2023
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

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