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RecruitingNCT06048289Updated Sep 25, 2023

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

An observational study in Biliary Tract Tumor and Cholangiocarcinoma, sponsored by Zhejiang Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by Zhejiang Cancer Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Biliary Tract Tumor
  • Cholangiocarcinoma

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03

In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's planned enrollment of 150 is below the median of 196 across 176 observational studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  1. Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Immunotherapy combined with chemotherapy

    Other: Blood samples, tumor biopsy specimens will be collected

Interventions

  • OtherBlood samples, tumor biopsy specimens will be collected

    Blood samples, tumor biopsy specimens at baseline will be collected

06

What researchers measure

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06048289
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Ying Jieer (Principal Investigator, Zhejiang Cancer Hospital) — Principal investigator
First posted
Sep 21, 2023
Start date
Sep 14, 2023 (estimated)
Primary completion
Mar 31, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Sep 25, 2023

Study contacts

Jieer Ying, Dr
Contact
jieerying@aliyun.com
13858195803
Biospecimen Retention Ying, Dr
principal investigator · Zhejiang Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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