Biliary Tract CancerPhase 1/2NCT06074029
Exploratory Study on the Therapeutic Effect Prediction Model of Advanced BTC Immunotherapy
A Phase 1/2 study testing Immune Checkpoint Inhibitors in people with Biliary Tract Cancer and Immune Checkpoint Inhibitor, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
1. Establish a predictive model for the efficacy of immune checkpoint inhibitors (ICI) in Chinese patients with biliary tract cancers. By analyzing the dynamic changes of circulating tumor DNA (ctDNA) and other clinical and pathological features before and after ICI treatment in a cohort of patients with biliary tract… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Cancer, Immune Checkpoint Inhibitor, Predictive Cancer Model
- What is being tested?
- Immune Checkpoint Inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Aug 2024
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.
- Patients with advanced biliary tract cancers (including gallbladder cancer, intrahepatic cholangiocarcinoma (ICC), hilar cholangiocarcinoma, or distal cholangiocarcinoma) with histologically, cytologically, or clinically confirmed.
- Patients who have undergone curative surgery and experienced disease recurrence after more than 6 months; or patients who have completed adjuvant therapy (chemotherapy and/or radiotherapy) and have been disease-free for more than 6 months after completing adjuvant therapy are eligible for inclusion.
- Regardless of gender, age 18-80 years old.
- ECOG PS of 0-2 with expected survival time ≥12 weeks.
- According to RECIST V1.1, the patient had at least one measurable lesion.
- The patient is suitable for treatment with immune checkpoint inhibitors (PD-1/PD-L1 inhibitor).
Who cannot join
- Suffering from other malignant tumors.
- Previous systemic treatment received.
- Patients with serious organic diseases cannot receive the treatment designed in this study;
- Having a psychiatric disorder does not guarantee compliance with this study.
- Patients with symptomatic brain metastasis or complications related to brain metastasis or cognitive impairment.
- Adverse events (except hair loss of any grade) from previous antitumor therapy did not return to ≤ grade 1 or better (According to CTCAE version 5.0).
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- Previously received any cell or organ transplant treatment.
- Allergy to the therapeutic drugs of this study or CT or MRI-enhanced contrast agents.
- Received local hepatobiliary treatment (including various types of ablations, percutaneous ethanol or acetic acid injection, high-intensity focused ultrasound, transarterial embolization, chemotherapy, or chemoembolization) within 14 days before the start of the study treatment.
- The physician determines that there are any contraindications to ICI treatment.
- During the second blood monitoring, the disease changes could not be judged (such as unexplained ascites, worsening symptoms); Or non-disease progression, but the next immunotherapy is not planned.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)
Beijing, Beijing Municipality, 100730
About this study
Official title: Exploratory Study on the Therapeutic Effect Prediction Model of Immune Checkpoint Inhibitors for Advanced Biliary Tract Cancer
- Establish a predictive model for the efficacy of immune checkpoint inhibitors (ICI) in Chinese patients with biliary tract cancers. By analyzing the dynamic changes of circulating tumor DNA (ctDNA) and other clinical and pathological features before and after ICI treatment in a cohort of patients with biliary tract tumors, a predictive model can be established to evaluate the efficacy of ICI treatment in the early stages or even before treatment, serving as a reliable tool for selecting patients who are likely to benefit from ICI treatment.
- Investigate the clinical features of populations that benefit from different immune combination therapies. By comparing the differences and enrichment of mutations between patients receiving different treatment regimens, and if patients have sufficient pre-treatment tissue, further comparisons of differentially expressed genes and pathways may be made.
- Being tested
- Immune Checkpoint Inhibitors
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Checkpoint InhibitorsDrug
Immune Checkpoint Inhibitors including Durvalumab, Pembrolizumab and Toripalimab
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy cohort | Experimental | Patients who were administered with immunotherapy Receives: Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
It refers to the time from the first administration of the regimen to the first occurrence of disease progression or death due to any cause in the subjects.
Measured: Baseline up to approximately 12 months
Secondary outcomes (3)
Objective response rate
The proportion of patients whose tumor volume shrinks to a predetermined value and can maintain the minimum required duration, including complete response and partial response.
Measured: Baseline up to approximately 6 months
Overall survival
The time from randomization to death due to any cause in the subjects.
Measured: Baseline up to approximately 15 months
Time to treatment discontinuation
The time from the beginning of ICI drug use to the cessation of ICI drug use for any reason
Measured: Baseline up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Dec 2021
- Primary completion30 Dec 2023
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Geneplus-Beijing Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074029
- Sponsor's protocol ID
- JYJ-001
- Status last verified
- Feb 2024
- First submitted
- 24 Sep 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Therapeutic Effect Prediction Model of Immune Checkpoint Inhibitors for Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT06074029
- Acronym / sponsor ID
- JYJ-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Geneplus-Beijing Co. Ltd.
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 10 Oct 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.
- Establish a predictive model for the efficacy of immune checkpoint inhibitors (ICI) in Chinese patients with biliary tract cancers. By analyzing the dynamic changes of circulating tumor DNA (ctDNA) and other clinical and pathological features before and after ICI treatment in a cohort of patients with biliary tract tumors, a predictive model can be established to evaluate the efficacy of ICI treatment in the early stages or even before treatment, serving as a reliable tool for selecting patients who are likely to benefit from ICI treatment.
- Investigate the clinical features of populations that benefit from different immune combination therapies. By comparing the differences and enrichment of mutations between patients receiving different treatment regimens, and if patients have sufficient pre-treatment tissue, further comparisons of differentially expressed genes and pathways may be made.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy cohort | Experimental | Drug: Immune Checkpoint InhibitorsPatients who were administered with immunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subjects voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.
- Patients with advanced biliary tract cancers (including gallbladder cancer, intrahepatic cholangiocarcinoma (ICC), hilar cholangiocarcinoma, or distal cholangiocarcinoma) with histologically, cytologically, or clinically confirmed.
- Patients who have undergone curative surgery and experienced disease recurrence after more than 6 months; or patients who have completed adjuvant therapy (chemotherapy and/or radiotherapy) and have been disease-free for more than 6 months after completing adjuvant therapy are eligible for inclusion.
- Regardless of gender, age 18-80 years old.
- ECOG PS of 0-2 with expected survival time ≥12 weeks.
Key exclusion criteria (11 listed)
- Suffering from other malignant tumors.
- Previous systemic treatment received.
- Patients with serious organic diseases cannot receive the treatment designed in this study;
- Having a psychiatric disorder does not guarantee compliance with this study.
- Patients with symptomatic brain metastasis or complications related to brain metastasis or cognitive impairment.
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 |
|---|---|---|
| Immune Checkpoint InhibitorsImmune Checkpoint Inhibitors including Durvalumab, Pembrolizumab and Toripalimab | Drug | Immunotherapy cohort |
Primary outcome
Progression free survival
Time frame: Baseline up to approximately 12 months
It refers to the time from the first administration of the regimen to the first occurrence of disease progression or death due to any cause in the subjects.
3 secondary outcomes
Objective response rate
Time frame: Baseline up to approximately 6 months
Overall survival
Time frame: Baseline up to approximately 15 months
Time to treatment discontinuation
Time frame: Baseline up to approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immune Checkpoint Inhibitors in people with Biliary Tract Cancer and Immune Checkpoint Inhibitor, run by Peking Union Medical College 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 11 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 8 Feb 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Baseline up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.