Biliary Tract TumorNCT06048289
Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy
An observational study of Biliary Tract Tumor and Cholangiocarcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Tumor, Cholangiocarcinoma
- What is being tested?
- Blood samples, tumor biopsy specimens will be collected
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jieer Ying, Doctor, 13858195803, hzyingjieer@163.com
About this study
Official title: Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors
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.
- Conditions
- Biliary Tract Tumor, Cholangiocarcinoma
- Being tested
- Blood samples, tumor biopsy specimens will be collected
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples, tumor biopsy specimens will be collectedOther
Blood samples, tumor biopsy specimens at baseline will be collected
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy combined with chemotherapy | Not described Receives: Other: Blood samples, tumor biopsy specimens will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start14 Sep 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract TumorStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jieer, Zhejiang Cancer Hospital
- Investigators
- Biospecimen Retention Ying, Dr, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048289
- Sponsor's protocol ID
- IRB-2020-404
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu Q, Zhou S, Zhang C, Zhou Y, He Y, Jiang Y, Li J, Yi T, Luo C, Zhang L, Wu J, Zhang Y, Wu M, Wei Q, Li Q, Liu B, Chen X, Yao Y, Yu C, Li J, Ren Y, Zhuo W, Yuan L, Li W, Wang ZM, Li B, Xia M, Xie Y, Wu K, Ying J. Ivonescimab plus gemcitabine and cisplatin as first-line therapy for advanced biliary tract cancer: a multicenter, open-label phase 2 trial. J Hepatol. 2026 Jul 6:S0168-8278(26)02682-6. doi: 10.1016/j.jhep.2026.06.033. Online ahead of print.
PubMed 42409321
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors
- ClinicalTrials.gov ID
- NCT06048289
- Acronym / sponsor ID
- IRB-2020-404
- Conditions
- Biliary Tract Tumor, Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 14 Sep 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy combined with chemotherapy | – | Other: Blood samples, tumor biopsy specimens will be collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples, tumor biopsy specimens will be collectedBlood samples, tumor biopsy specimens at baseline will be collected | Other | Immunotherapy combined with chemotherapy |
Primary outcome
Identifying predictive biomarkers of immunotherapy response
Time frame: 1 year
ldentifying predictive biomarkers of immunotherapy response by detecting differences in genome and transcriptome sequencing between responder and non-responder patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 42409321Xu Q, Zhou S, Zhang C, Zhou Y, He Y, Jiang Y, Li J, Yi T, Luo C, Zhang L, Wu J, Zhang Y, Wu M, Wei Q, Li Q, Liu B, Chen X, Yao Y, Yu C, Li J, Ren Y, Zhuo W, Yuan L, Li W, Wang ZM, Li B, Xia M, Xie Y, Wu K, Ying J. Ivonescimab plus gemcitabine and cisplatin as first-line therapy for advanced biliary tract cancer: a multicenter, open-label phase 2 trial. J Hepatol. 2026 Jul 6:S0168-8278(26)02682-6. doi: 10.1016/j.jhep.2026.06.033. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biospecimen Retention Ying, Dr principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Tumor and Cholangiocarcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieer Ying, Dr (13858195803, jieerying@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying predictive biomarkers of immunotherapy response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06048289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.