Biliary Tract CancerPhase 2NCT07135544
A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer
A Phase 2 study testing Adebrelimab combined with the GC regimen and Apatinib in people with Biliary Tract Cancer and Biliary Tract Cancer (CCA), run by Yongjun Chen at 1 site in China.
Trial summary
This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Cancer, Biliary Tract Cancer (CCA)
- What is being tested?
- Adebrelimab combined with the GC regimen and Apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Pathological or histological diagnosis of malignant tumor of the biliary tract; 2. Patients who are classified as TxNx and TxNxM1 according to the UICC/AJCC TNM staging system (9th edition, 2024), and who, based on the judgment of the research team, meet the criteria for newly diagnosed incurable cases or are not suitable for surgery; 3. Age: 18-80 years old; 4. Expected survival period > 3 months; 5. Both genders are eligible; 6. ECOG PS score of 0 or 1; 7. No severe complications, such as hypertension, coronary heart disease, and history of mental illness, no severe allergy history; non-pregnant and non-lactating; 8. The patient's organ and hematological system functions meet the following requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Platelet count ≥ 75 × 10^9/L;
- Hemoglobin ≥ 90 g/L;
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN;
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- Albumin ≥ 3 g/dL
- Creatinine ≤ 1.5 x ULN 9. Patients can understand and sign the informed consent form to participate in the trial study; good compliance.
- 10. Newly diagnosed patients, who have not undergone any local or systemic treatment for the tumor in the past and have undergone radical resection surgery for biliary cancer, and whose disease recurs 2 years after the surgery can be included; 11. Patients with potential fertility should use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and within 1 month after the end of the study treatment; and the serum or urine HCG test must be negative within 72 hours before the study enrollment, and must be non-lactating.
Who cannot join
- 1. Patients who received immune checkpoint inhibitors before enrollment, or those who directly received another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, CD137); 2. Patients who used any other investigational drug within 4 weeks before enrollment; 3. Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); children with asthma who have completely recovered after adulthood and do not require any intervention can be included, but patients requiring bronchodilator drug intervention cannot be included; 4. Congenital or acquired immune deficiencies, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA > 500 IU/ml), hepatitis C (positive hepatitis C antibody, HCV-RNA above the detection limit of the analytical method), or co-infection of hepatitis B and hepatitis C; 5. Serious infections occurred within 4 weeks before the first administration (such as intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5°C during screening or before the first administration; 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Having an uncontrolled mental disorder; 8. Concurrently having severe and/or uncontrollable diseases that may affect the participation in the study, such as unstable angina pectoris, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, poorly controlled diabetes, excessive activity, uncontrollable infection after insufficient biliary drainage (such as tumor blocking the bile duct); 9. Other cancers that occurred in the past (within the past 5 years) or simultaneously, excluding non-melanoma skin cancer and carcinoma in situ; 10. History of allergy or hypersensitivity to any study drug or any monoclonal antibody; 11. Unable or unwilling to sign the informed consent form.
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
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Yongjun Chen Yongjun Chen, 027-83662379, yjchen@tjh.tjmu.edu.cn
About this study
This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigated.
- Conditions
- Biliary Tract Cancer, Biliary Tract Cancer (CCA)
- Being tested
- Adebrelimab combined with the GC regimen and Apatinib
- Keywords
- Adebrelimab
- 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.
Adebrelimab combined with the GC regimen and ApatinibDrug
Adebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab combined with the GC regimen and Apatinib | Experimental | Adebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally Receives: Drug: Adebrelimab combined with the GC regimen and Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: At the end of Cycle 6 and 10 (each cycle is 21 days)
Secondary outcomes (4)
DCR
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Measured: up to 18 months
PFS
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: up to 24 months
AE
Overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use
Measured: up to 24 months
OS
Time from randomization to death from any cause
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start14 Aug 2025
- Primary completion30 Jun 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongjun Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongjun Chen, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135544
- Sponsor's protocol ID
- BTC-001
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07135544
- Acronym / sponsor ID
- BTC-001
- Conditions
- Biliary Tract Cancer, Biliary Tract Cancer (CCA)
- Keywords
- Adebrelimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Yongjun ChenUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 22 Aug 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 is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab combined with the GC regimen and Apatinib | Experimental | Drug: Adebrelimab combined with the GC regimen and ApatinibAdebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Pathological or histological diagnosis of malignant tumor of the biliary tract; 2. Patients who are classified as TxNx and TxNxM1 according to the UICC/AJCC TNM staging system (9th edition, 2024), and who, based on the judgment of the research team, meet the criteria for newly diagnosed incurable cases or are not suitable for surgery; 3. Age: 18-80 years old; 4. Expected survival period > 3 months; 5. Both genders are eligible; 6. ECOG PS score of 0 or 1; 7. No severe complications, such as hypertension, coronary heart disease, and history of mental illness, no severe allergy history; non-pregnant and non-lactating; 8. The patient's organ and hematological system functions meet the following requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Platelet count ≥ 75 × 10^9/L;
- Hemoglobin ≥ 90 g/L;
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN);
Key exclusion criteria (1 listed)
- 1. Patients who received immune checkpoint inhibitors before enrollment, or those who directly received another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, CD137); 2. Patients who used any other investigational drug within 4 weeks before enrollment; 3. Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); children with asthma who have completely recovered after adulthood and do not require any intervention can be included, but patients requiring bronchodilator drug intervention cannot be included; 4. Congenital or acquired immune deficiencies, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA > 500 IU/ml), hepatitis C (positive hepatitis C antibody, HCV-RNA above the detection limit of the analytical method), or co-infection of hepatitis B and hepatitis C; 5. Serious infections occurred within 4 weeks before the first administration (such as intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5°C during screening or before the first administration; 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Having an uncontrolled mental disorder; 8. Concurrently having severe and/or uncontrollable diseases that may affect the participation in the study, such as unstable angina pectoris, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, poorly controlled diabetes, excessive activity, uncontrollable infection after insufficient biliary drainage (such as tumor blocking the bile duct); 9. Other cancers that occurred in the past (within the past 5 years) or simultaneously, excluding non-melanoma skin cancer and carcinoma in situ; 10. History of allergy or hypersensitivity to any study drug or any monoclonal antibody; 11. Unable or unwilling to sign the informed consent form.
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 |
|---|---|---|
| Adebrelimab combined with the GC regimen and ApatinibAdebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally | Drug | Adebrelimab combined with the GC regimen and Apatinib |
Primary outcome
ORR
Time frame: At the end of Cycle 6 and 10 (each cycle is 21 days)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
4 secondary outcomes
DCR
Time frame: up to 18 months
PFS
Time frame: up to 24 months
AE
Time frame: up to 24 months
OS
Time frame: up to 24 months
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 22 Aug 2025.
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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 Adebrelimab combined with the GC regimen and Apatinib in people with Biliary Tract Cancer and Biliary Tract Cancer (CCA), run by Yongjun Chen 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 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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 Yongjun Chen Yongjun Chen (027-83662379, yjchen@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: At the end of Cycle 6 and 10 (each cycle is 21 days)). 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 22 Aug 2025.