Unresectable Biliary Tract CancerBTCICTY-001NCT06849193
Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study
An observational study of Unresectable Biliary Tract Cancer and Dynamic Prediction Model, run by Zhongda Hospital at 2 sites in China.
Trial summary
This study focused on the longitudinal tumor burden profile (tumor macro features, histopathological types and imaging features, etc.), liver function, health status, tumor biomarkers, and serological indicators of patients with unresectable biliary malignancies before chemotherapy combined with immunotherapy to build… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Biliary Tract Cancer, Dynamic Prediction Model, Immunotherapy
- What is being tested?
- Systemic chemotherapy combined with immunotherapy
- How many people
- 332 participants
- Where
- 2 sitesChina
- Study dates
- 31 Jan 2025to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The target population of this project is patients diagnosed with unresectable biliary malignancies and treated with systemic chemotherapy combined with immunosuppressive agents.
Who may be able to join
- 1. Confirmed by histopathological diagnosis and/or clinical diagnosis (typical imaging features, clinical manifestations, laboratory examination, etc.) as biliary malignancy (Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Biliary malignancy (2024)); 2. Based on unresectable malignant tumor in the diagnosis of biliary and in patients undergoing chemotherapy with immunosuppressant therapy system; 3. The liver function class for Child - Pugh, A or B; 4. More than 18 years of age, gender not limited; 5. Expected survival time for 3 months or more; 6. ECOG PS score 2 or less; 7. Meet the following laboratory test parameters:
- Hematological system function: Absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; international normalized ratio less than 1.7 or prothrombin time prolongation not exceeding 4 seconds.
- Liver function: Alanine aminotransferase/aspartate aminotransferase not exceeding 5 times the upper limit of normal; total bilirubin ≤ 210 μmol/L [≤ 2.38 mg/dL]; albumin ≥ 28 g/L.
- Renal function: Serum creatinine not exceeding 1.5 times the upper limit of normal.
Who cannot join
- Malignant tumors other than BTC;
- Moderate to severe ascites (ascites reaching a Child-Pugh score of 3);
- Any local treatment (including transcatheter interventional therapy, ablation therapy, internal/external radiotherapy, etc.) or surgical resection or traditional Chinese medicine within 4 weeks before the combination of systemic chemotherapy and immunotherapy;
- Incomplete data, such as incomplete laboratory test data, missing or poor-quality imaging data, or lack of prognostic information;
- Severe liver dysfunction, such as decompensated cirrhosis and other liver diseases that significantly affect bilirubin levels;
- Severe comorbidities, such as refractory hypertension (blood pressure still higher than 150/100 mm Hg after optimal drug treatment), persistent arrhythmia (CTCAE grade 2 or above), any degree of atrial fibrillation, prolonged QTc interval (more than 450 milliseconds in men and more than 470 milliseconds in women), renal insufficiency, etc.;
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- Human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome;
- Pregnant or lactating women;
- Acute or chronic mental disorders (including mental disorders that affect the subject's enrollment, treatment intervention, and follow-up).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Recruiting
Zhongda Hospital,
Nanjing, Jiangsu
Gao-Jun Teng, M.D, +86-02583272121, gjteng@vip.sina.com
- Active, not recruiting
Zhongda Hospital
Nanjing, Jiangsu
About this study
This study focused on the longitudinal tumor burden profile (tumor macro features, histopathological types and imaging features, etc.), liver function, health status, tumor biomarkers, and serological indicators of patients with unresectable biliary malignancies before chemotherapy combined with immunotherapy to build a dynamic prediction model. Based on this model, risk stratification of BTC patients was realized to explore which specific populations could safely initiate combination therapy. By constructing a risk stratification model, it can help clinicians to screen the best treatment population and provide a basis for safe treatment of high-risk patients.
- Being tested
- Systemic chemotherapy combined with immunotherapy
- Keywords
- Unresectable Biliary Tract Cancer, immunotherapy, Dynamic prediction model, systemic chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic chemotherapy combined with immunotherapyDrug
The electronic medical record system was used to collect patients' basic information and treatment plan information, including treatment plan, administration cycle, administration date, administration dose, frequency, number of cycles, efficacy, adverse reactions, etc.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Measured: up to approximately 2 years
Secondary outcomes (4)
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1, mRECIST and iRECIST) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
Objective response rate(ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1, mRECIST and iRECIST.
Measured: up to approximately 2 years
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RECIST 1.1, mRECIST and iRECIST.
Measured: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start31 Jan 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable Biliary Tract CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Affiliated Hospital of Soochow University, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital, University of Science and Technology of China, Zhejiang Cancer Hospital, Shanghai Zhongshan Hospital, Yunnan Cancer Hospital
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, M.D, Principal investigator, Zhongda hospital, Southeast university, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849193
- Sponsor's protocol ID
- 2024040196
- Acronym
- BTCICTY-001
- Status last verified
- Jan 2025
- First submitted
- 23 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Mei JH, Zhang K, Zhang Y, Li Z, Ge NJ, Han X, Zhong SX, Zhang XP, Wu PP, Lv WF, Wu J, Wu JX, Wang C, Yan H, Huang T, Liu J, Jia KZ, Liu Y, Guo JH, Liu R, Teng GJ, Lu J. Machine Learning-Guided Personalized Immunochemotherapy Strategies in Intrahepatic Cholangiocarcinoma. JHEP Rep. 2026 Aug 22:102004. doi: 10.1016/j.jhepr.2026.102004. Online ahead of print.
PubMed 42632422Mei JH, Han X, Zhang K, Ge NJ, Li Z, Zhang XP, Wu PP, Lv WF, Wu J, Wu JX, Wang C, Li J, Liu PJ, Yan H, Li Z, Liu J, Zhang Y, Liu Y, Huang T, Guo JH, Liu R, Teng GJ, Lu J. A Dynamic Prognostic and Adaptive Treatment Framework for Advanced Biliary Tract Cancer. JHEP Rep. 2026 Aug 1:101976. doi: 10.1016/j.jhepr.2026.101976. Online ahead of print.
PubMed 42542210
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT06849193
- Acronym / sponsor ID
- BTCICTY-001 / 2024040196
- Keywords
- Unresectable Biliary Tract Cancer, immunotherapy, Dynamic prediction model, systemic chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Affiliated Hospital of Soochow University, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital, University of Science and Technology of China, Zhejiang Cancer Hospital, Shanghai Zhongshan Hospital, Yunnan Cancer Hospital
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 27 Feb 2025 (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.
This study focused on the longitudinal tumor burden profile (tumor macro features, histopathological types and imaging features, etc.), liver function, health status, tumor biomarkers, and serological indicators of patients with unresectable biliary malignancies before chemotherapy combined with immunotherapy to build a dynamic prediction model. Based on this model, risk stratification of BTC patients was realized to explore which specific populations could safely initiate combination therapy. By constructing a risk stratification model, it can help clinicians to screen the best treatment population and provide a basis for safe treatment of high-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of this project is patients diagnosed with unresectable biliary malignancies and treated with systemic chemotherapy combined with immunosuppressive agents.
Key inclusion criteria (4 listed)
- 1. Confirmed by histopathological diagnosis and/or clinical diagnosis (typical imaging features, clinical manifestations, laboratory examination, etc.) as biliary malignancy (Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Biliary malignancy (2024)); 2. Based on unresectable malignant tumor in the diagnosis of biliary and in patients undergoing chemotherapy with immunosuppressant therapy system; 3. The liver function class for Child - Pugh, A or B; 4. More than 18 years of age, gender not limited; 5. Expected survival time for 3 months or more; 6. ECOG PS score 2 or less; 7. Meet the following laboratory test parameters:
Key exclusion criteria (9 listed)
- Malignant tumors other than BTC;
- Moderate to severe ascites (ascites reaching a Child-Pugh score of 3);
- Any local treatment (including transcatheter interventional therapy, ablation therapy, internal/external radiotherapy, etc.) or surgical resection or traditional Chinese medicine within 4 weeks before the combination of systemic chemotherapy and immunotherapy;
- Incomplete data, such as incomplete laboratory test data, missing or poor-quality imaging data, or lack of prognostic information;
- Severe liver dysfunction, such as decompensated cirrhosis and other liver diseases that significantly affect bilirubin levels;
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 |
|---|---|---|
| Systemic chemotherapy combined with immunotherapyThe electronic medical record system was used to collect patients' basic information and treatment plan information, including treatment plan, administration cycle, administration date, administration dose, frequency, number of cycles, efficacy, adverse reactions, etc. | Drug | – |
Primary outcome
Overall Survival(OS)
Time frame: up to approximately 2 years
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
4 secondary outcomes
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
Time frame: up to approximately 2 years
Objective response rate(ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
Time frame: up to approximately 2 years
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
Time frame: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
Time frame: up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 42632422Mei JH, Zhang K, Zhang Y, Li Z, Ge NJ, Han X, Zhong SX, Zhang XP, Wu PP, Lv WF, Wu J, Wu JX, Wang C, Yan H, Huang T, Liu J, Jia KZ, Liu Y, Guo JH, Liu R, Teng GJ, Lu J. Machine Learning-Guided Personalized Immunochemotherapy Strategies in Intrahepatic Cholangiocarcinoma. JHEP Rep. 2026 Aug 22:102004. doi: 10.1016/j.jhepr.2026.102004. Online ahead of print.
- Derived from this study: PubMed 42542210Mei JH, Han X, Zhang K, Ge NJ, Li Z, Zhang XP, Wu PP, Lv WF, Wu J, Wu JX, Wang C, Li J, Liu PJ, Yan H, Li Z, Liu J, Zhang Y, Liu Y, Huang T, Guo JH, Liu R, Teng GJ, Lu J. A Dynamic Prognostic and Adaptive Treatment Framework for Advanced Biliary Tract Cancer. JHEP Rep. 2026 Aug 1:101976. doi: 10.1016/j.jhepr.2026.101976. Online ahead of print.
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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.
Gao-Jun Teng, M.D principal investigator
Zhongda hospital, Southeast university, Nanjing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Biliary Tract Cancer and Dynamic Prediction Model, run by Zhongda Hospital at 2 sites 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gao-Jun Teng, M.D (+86-02583272121, gjteng@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: up to approximately 2 years). 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 NCT06849193, which also lists 2 linked publications.
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 27 Feb 2025.