Biliary Tract CancerPhase 2NCT07569679
Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer
A Phase 2 study testing HAIC, Gemcitabine plus Cisplatin and Adebrelimab in people with Biliary Tract Cancer, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
This prospective real-world study aims to evaluate the effectiveness and safety of an alternating treatment regimen combining hepatic arterial infusion chemotherapy (HAIC) with systemic chemotherapy, with or without adebrelimab and apatinib, in patients with unresectable biliary tract cancer receiving first-line… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- HAIC, Gemcitabine plus Cisplatin and Adebrelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 30 Dec 2028
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥ 18 years at the time of enrollment.
- Histologically or cytologically confirmed diagnosis unresectable, locally advanced, or metastatic BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
- No prior systemic therapy for BTC, including chemotherapy, immunotherapy, or small-molecule targeted therapy.
- Patients with disease recurrence ≥6 months after curative resection and completion of adjuvant therapy (chemotherapy or radiotherapy) are eligible.
- Adequate liver function: defined as Child-Pugh Class A (score 5-6) or well-compensated Class B (score ≤7).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Show all 9Show fewer
- At least one measurable lesion as defined by RECIST 1.1.
- Assessed by the investigator as being able to tolerate and comply with the study treatment regimen.
- Provision of written informed consent, voluntarily agreeing to participate after full explanation of the study protocol.
Who cannot join
- Hepatic tumor burden occupying ≥50% of total liver volume.
- History of liver transplantation.
- Major surgery or invasive procedure (excluding intravenous catheter placement or percutaneous drainage) within 4 weeks prior to enrollment.
- History or evidence of clinically significant bleeding, including: bleeding >30 mL within 3 months prior to enrollment (including hematemesis, melena, or hematochezia), hemoptysis (>5 mL of fresh blood) within 4 weeks prior to enrollment, or thromboembolic events (including stroke or transient ischemic attack) within the past 12 months.
- Known active infection with human immunodeficiency virus (HIV).
- Pregnant (a positive pregnancy test prior to study drug administration) or breastfeeding women.
- Any condition, in the investigator's judgment, that could compromise patient satety, affect the assessment of study outcomes, or lead to premature discontinuation. this includes, but is not limited to: active alcohol or substance abuse, severe uncontrolled comorbidities, significant laboratory abnormalities, or social/family circumstances that could interfere with protocol compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Air Force Military Medical University
Xi'an, Shaanxi, 710032
Jun Tie, M.D.,Ph.D. Jun Tie, M.D.,Ph.D., +862984771537, tiejun7776@163.com
About this study
Official title: A Prospective, Real-World Study of Alternating Hepatic Arterial Infusion Chemotherapy and Systemic Chemotherapy With or Without Adebrelimab and Apatinib in Patients With Unresectable Biliary Tract Cancer
This prospective real-world study aims to evaluate the effectiveness and safety of an alternating treatment regimen combining hepatic arterial infusion chemotherapy (HAIC) with systemic chemotherapy, with or without adebrelimab and apatinib, in patients with unresectable biliary tract cancer receiving first-line treatment. The study comprises two cohorts: one receiving alternating HAIC and systemic chemotherapy alongside adebrelimab and apatinib, and the other receiving alternating HAIC and systemic chemotherapy alone. Treatment allocation follows real-world clinical decision-making. Patients will be monitored throughout the treatment period to assess tumor response, survival outcomes, and safety profiles. The study aims to generate evidence on the clinical benefits of integrating immunotherapy and targeted therapy into HAIC-based regimens for this patient population.
Read the detailed description
Biliary tract cancer (BTC), which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, is an aggressive malignancy associated with a generally poor prognosis. For patients with unresectable, locally advanced, or metastatic disease, first-line systemic chemotherapy using gemcitabine and cisplatin remains the standard of care, although treatment outcomes are ofter suboptimal. HAIC has gained increasing attention in clinical practice, paticularly in China, for its ability to enhance local drug delivery and improve tumor control in cases of liver-dominant disease. Alternating HAIC with systemic chemotherapy may provide additive benefits by simultaneously targeting both intrahepatic and extrahepatic lesions.
Recent advances in immunotherapy and anti-angiogenic therapy have shown promise results in BTC. Adebrelimab, a PD-L1 inhibitor, and apatinib, a VEGFR2 inhibitor, have demonstrated antitumor activity in various solid tumors. Combining these agents with chemotherapy and HAIC may yield synergistic effects, potentially improving response rates and extending survival.
This prospective real-world study is designed to evaluate the effectiveness and safety of an alternating regimen of HAIC and systemic chemotherapy (gemcitabine plus cisplatin), with or without adebrelimab and apatinib, in patients with previously untreated, unresectable, locally advanced or metastatic BTC. Participants will be assigned to one of two cohorts based on patient preference and clinician judgment: Cohort A will receive HAIC and systemic chemotherapy combined with adebrelimab and apatinib, while Cohort B will receive HAIC and systemic chemotherapy alone. Dosing and administration will follow the standard treatment protocols.
The study will capture real-world data on objective tumor response, progression-free survival, overall survival, and safety profiles. Exploratory analyses may include patterns of disease progression, treatment adherence, and the influence of clinical and biological factors on outcomes. The results are anticipated to offer valuable evidence to guide clinical decision-making and help optimize first-line treatment strategies for patients with advanced BTC in routine practice.
- Conditions
- Biliary Tract Cancer
- Being tested
- HAIC, Gemcitabine plus Cisplatin, Adebrelimab, Apatinib
- Keywords
- Biliary Tract Cancer, First-Line Treatment, HAIC, Adebrelimab, Apatinib
- 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.
HAICProcedure or surgery
HAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.
Gemcitabine plus CisplatinDrug
Gemcitabine and cisplatin administered intravenously according to institutional standard first-line regimens for biliary tract cancer. Dosing and schedule follow each center's standard treatment protocols.
AdebrelimabDrug
Adebrelimab administered intravenously at a dose of 1200 mg every 3 weeks until disease progression or unacceptable toxicity.
ApatinibDrug
Apatinib administered orally at a dose of 250 mg once daily until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib | Experimental | Participants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin, combined with adebrelimab (1200 mg every 3 weeks) and apatinib (250 mg orally once daily). The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols. Receives: Procedure: HAIC; Drug: Gemcitabine plus Cisplatin; Drug: Adebrelimab; Drug: Apatinib |
| Alternating HAIC and Systemic Chemotherapy Alone | Active comparator | Participants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin. The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols. Receives: Procedure: HAIC; Drug: Gemcitabine plus Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival (OS) was defined as the time from initiation of study treatment (first dose) to death from any cause.
Measured: The maximum time from receiving treatment to dying for any reason is 3 years.
Secondary outcomes (3)
Progression-free Survival (PFS)
Progression-free survival (PFS), assessed by investigators per RECIST version 1.1, was defined as the time from initiation of study treatment (first dose) to the first documentation of objective disease progression or death from any cause, which ever occurred first.
Measured: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Objective Response Rate (ORR)
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion.
Measured: Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.
Disease Control Rate (DCR)
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD).
Measured: Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 Dec 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tie Jun, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569679
- Sponsor's protocol ID
- KY20252547-C-1
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Real-World Study of Alternating Hepatic Arterial Infusion Chemotherapy and Systemic Chemotherapy With or Without Adebrelimab and Apatinib in Patients With Unresectable Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07569679
- Acronym / sponsor ID
- KY20252547-C-1
- Conditions
- Biliary Tract Cancer
- Keywords
- Biliary Tract Cancer, First-Line Treatment, HAIC, Adebrelimab, Apatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 May 2026 (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 prospective real-world study aims to evaluate the effectiveness and safety of an alternating treatment regimen combining hepatic arterial infusion chemotherapy (HAIC) with systemic chemotherapy, with or without adebrelimab and apatinib, in patients with unresectable biliary tract cancer receiving first-line treatment. The study comprises two cohorts: one receiving alternating HAIC and systemic chemotherapy alongside adebrelimab and apatinib, and the other receiving alternating HAIC and systemic chemotherapy alone. Treatment allocation follows real-world clinical decision-making. Patients will be monitored throughout the treatment period to assess tumor response, survival outcomes, and safety profiles. The study aims to generate evidence on the clinical benefits of integrating immunotherapy and targeted therapy into HAIC-based regimens for this patient population.
Detailed description
Biliary tract cancer (BTC), which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, is an aggressive malignancy associated with a generally poor prognosis. For patients with unresectable, locally advanced, or metastatic disease, first-line systemic chemotherapy using gemcitabine and cisplatin remains the standard of care, although treatment outcomes are ofter suboptimal. HAIC has gained increasing attention in clinical practice, paticularly in China, for its ability to enhance local drug delivery and improve tumor control in cases of liver-dominant disease. Alternating HAIC with systemic chemotherapy may provide additive benefits by simultaneously targeting both intrahepatic and extrahepatic lesions.
Recent advances in immunotherapy and anti-angiogenic therapy have shown promise results in BTC. Adebrelimab, a PD-L1 inhibitor, and apatinib, a VEGFR2 inhibitor, have demonstrated antitumor activity in various solid tumors. Combining these agents with chemotherapy and HAIC may yield synergistic effects, potentially improving response rates and extending survival.
This prospective real-world study is designed to evaluate the effectiveness and safety of an alternating regimen of HAIC and systemic chemotherapy (gemcitabine plus cisplatin), with or without adebrelimab and apatinib, in patients with previously untreated, unresectable, locally advanced or metastatic BTC. Participants will be assigned to one of two cohorts based on patient preference and clinician judgment: Cohort A will receive HAIC and systemic chemotherapy combined with adebrelimab and apatinib, while Cohort B will receive HAIC and systemic chemotherapy alone. Dosing and administration will follow the standard treatment protocols.
The study will capture real-world data on objective tumor response, progression-free survival, overall survival, and safety profiles. Exploratory analyses may include patterns of disease progression, treatment adherence, and the influence of clinical and biological factors on outcomes. The results are anticipated to offer valuable evidence to guide clinical decision-making and help optimize first-line treatment strategies for patients with advanced BTC in routine practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib | Experimental | Procedure: HAIC, Drug: Gemcitabine plus Cisplatin, Drug: Adebrelimab, Drug: ApatinibParticipants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin, combined with adebrelimab (1200 mg every 3 weeks) and apatinib (250 mg orally once daily). The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols. |
| Alternating HAIC and Systemic Chemotherapy Alone | Active comparator | Procedure: HAIC, Drug: Gemcitabine plus CisplatinParticipants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin. The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years at the time of enrollment.
- Histologically or cytologically confirmed diagnosis unresectable, locally advanced, or metastatic BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
- No prior systemic therapy for BTC, including chemotherapy, immunotherapy, or small-molecule targeted therapy.
- Patients with disease recurrence ≥6 months after curative resection and completion of adjuvant therapy (chemotherapy or radiotherapy) are eligible.
- Adequate liver function: defined as Child-Pugh Class A (score 5-6) or well-compensated Class B (score ≤7).
Key exclusion criteria (7 listed)
- Hepatic tumor burden occupying ≥50% of total liver volume.
- History of liver transplantation.
- Major surgery or invasive procedure (excluding intravenous catheter placement or percutaneous drainage) within 4 weeks prior to enrollment.
- History or evidence of clinically significant bleeding, including: bleeding >30 mL within 3 months prior to enrollment (including hematemesis, melena, or hematochezia), hemoptysis (>5 mL of fresh blood) within 4 weeks prior to enrollment, or thromboembolic events (including stroke or transient ischemic attack) within the past 12 months.
- Known active infection with human immunodeficiency virus (HIV).
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 |
|---|---|---|
| HAICHAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols. | Procedure or surgery | Alternating HAIC and Systemic Chemotherapy Alone, Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib |
| Gemcitabine plus CisplatinGemcitabine and cisplatin administered intravenously according to institutional standard first-line regimens for biliary tract cancer. Dosing and schedule follow each center's standard treatment protocols. | Drug | Alternating HAIC and Systemic Chemotherapy Alone, Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib |
| AdebrelimabAdebrelimab administered intravenously at a dose of 1200 mg every 3 weeks until disease progression or unacceptable toxicity. | Drug | Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib |
| ApatinibApatinib administered orally at a dose of 250 mg once daily until disease progression or unacceptable toxicity. | Drug | Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib |
Primary outcome
Overall Survival (OS)
Time frame: The maximum time from receiving treatment to dying for any reason is 3 years.
Overall survival (OS) was defined as the time from initiation of study treatment (first dose) to death from any cause.
3 secondary outcomes
Progression-free Survival (PFS)
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Objective Response Rate (ORR)
Time frame: Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.
Disease Control Rate (DCR)
Time frame: Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 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 6 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAIC, Gemcitabine plus Cisplatin and Adebrelimab in people with Biliary Tract Cancer, run by Air Force Military Medical University, China 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 9 inclusion and 7 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 6 May 2026. 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 phase mean?
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?
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 Jun Tie, Dr (+8618629507963, tiejun7776@163.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: The maximum time from receiving treatment to dying for any reason is 3 years.). 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 6 May 2026.