Biliary Tract NeoplasmsPhase 2NCT07668453
An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies
A Phase 2 study testing Adebrelimab, gemcitabine and Albumin-Bound Paclitaxel /nab-Paclitaxel in people with Biliary Tract Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of a new combination therapy for patients with biliary tract cancer that cannot be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Neoplasms
- What is being tested?
- Adebrelimab, gemcitabine and Albumin-Bound Paclitaxel /nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2025to 31 Dec 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, male or female. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. No prior local or systemic treatment for biliary tract malignancy. Histologically or cytologically confirmed initially unresectable or inoperable biliary tract cancer; recurrent biliary tract tumor after surgery; or patients who received post-operative adjuvant therapy must have been off treatment for more than 6 months. Adequate organ and hematological function. Life expectancy of ≥ 3 months. Laboratory results within 7 days prior to the first dose meeting the following criteria:Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, Platelets ≥ 75 × 10^9/L, Hemoglobin ≥ 90 g/L (without blood transfusion or G-CSF within 2 weeks prior to screening); Serum albumin ≥ 30 g/L, Total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Serum creatinine ≤ 1.5 × ULN or Creatinine clearance > 50 mL/min; INR ≤ 1.2 or PT exceeding the normal control range by ≤ 2 seconds; Urine protein < 2+ (if ≥ 2+, 24-hour urine protein quantification must be < 1.0 g). Women of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must not be lactating. Male subjects with female partners of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug, and must not donate sperm during this period.
Who cannot join
- Pathological diagnosis of mixed hepatocellular carcinoma or containing other non-cholangiocarcinoma malignant components. Prior systemic therapy. History of or concurrent other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid cancer. Active pulmonary tuberculosis infection within 1 year prior to enrollment; or history of active tuberculosis infection over 1 year ago without formal anti-tuberculosis treatment or with tuberculosis still in the active phase. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis. Requiring long-term systemic corticosteroid therapy (dose equivalent to > 10 mg/day prednisone) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are allowed. Severe cardiopulmonary or renal dysfunction. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); history of hypertensive crisis or hypertensive encephalopathy. HBV DNA > 2000 IU/ml, or active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection). Active infection requiring systemic therapy. Human immunodeficiency virus (HIV 1/2 antibody) positive. History of psychotropic drug abuse, alcoholism, or drug addiction. History of allergy to study drugs. Other factors that, in the judgment of the investigator, may affect the safety of the subject or compliance with the trial
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
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Yongxiang Xia, Doctor, ＋8613815893869, yx_xia@njmu.edu.cn
Yongxiang Xia, yx_xia@njmu.edu.cn
About this study
The purpose of this clinical trial is to evaluate the safety and effectiveness of a new combination therapy for patients with biliary tract cancer that cannot be removed by surgery. Participants will receive an immunotherapy drug called adebrelimab combined with two chemotherapy drugs (gemcitabine and albumin-bound paclitaxel) as their first-line treatment. This is an open-label, single-arm study, meaning all enrolled patients will receive this same combination treatment. The main goal of the study is to determine the Objective Response Rate (ORR), which measures the proportion of patients whose tumors shrink in response to the treatment. Researchers will also evaluate how long patients live without the disease getting worse (Progression-Free Survival), overall survival, quality of life, and any side effects experienced. The study plans to enroll 30 participants.
- Conditions
- Biliary Tract Neoplasms
- Being tested
- Adebrelimab, gemcitabine, Albumin-Bound Paclitaxel /nab-Paclitaxel
- 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.
AdebrelimabBiological
1200 mg, intravenous (IV) infusion, administered on Day 1 of each 21-day cycle.
gemcitabineDrug
800 mg/m^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.
Albumin-Bound Paclitaxel /nab-PaclitaxelDrug
100 mg/m^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants in this single arm will receive Adebrelimab (1200 mg, IV, Day 1), Gemcitabine (800 mg/m^2, IV, Days 1 and 8), and albumin-bound paclitaxel (100 mg/m^2, IV, Days 1 and 8) every 3 weeks (21 days) for 6 to 8 cycles. Adebrelimab is administered first, followed by chemotherapy after an interval of at least 30 minutes.
Maintenance phase: After 6-8 cycles of initial treatment, Adebrelimab will be continued for up to 2 years, while Gemcitabine and albumin-bound paclitaxel will be administered alternately every cycle.
Treatment continues until disease progression/recurrence, unacceptable toxicity, withdrawal of consent, or other specified discontinuation criteria are met. Receives: Biological: Adebrelimab; Drug: gemcitabine; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of patients whose tumor volume shrinks to a predefined value and maintains the minimum time requirement, defined as the sum of Complete Response (CR) and Partial Response (PR). Assessed by investigators according to RECIST 1.1 criteria.
Measured: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
Secondary outcomes (5)
Progression-Free Survival (PFS)
The time from the start of treatment to the first observation of disease progression or death from any cause. Assessed according to RECIST 1.1 criteria.
Measured: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Measured: From the first dose of study treatment until death from any cause, assessed up to approximately 36 months.
Disease Control Rate (DCR)
The proportion of patients who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after treatment. Assessed according to RECIST 1.1 criteria.
Measured: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
Duration of Response (DoR)
The time from the first confirmed disease response to the first confirmed disease progression or termination of the response status due to any cause (such as disease recurrence or patient death).
Measured: From the first confirmed response until disease progression or death, assessed up to approximately 24 months.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluated based on the incidence and severity of AEs and SAEs according to the NCI-CTCAE v5.0 standard.
Measured: From the signing of informed consent up to 90 days after the last dose of study medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start20 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668453
- Sponsor's protocol ID
- 26-OBU-JS-BTC-II-010
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies
- ClinicalTrials.gov ID
- NCT07668453
- Acronym / sponsor ID
- 26-OBU-JS-BTC-II-010
- Conditions
- Biliary Tract Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jun 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.
The purpose of this clinical trial is to evaluate the safety and effectiveness of a new combination therapy for patients with biliary tract cancer that cannot be removed by surgery. Participants will receive an immunotherapy drug called adebrelimab combined with two chemotherapy drugs (gemcitabine and albumin-bound paclitaxel) as their first-line treatment. This is an open-label, single-arm study, meaning all enrolled patients will receive this same combination treatment. The main goal of the study is to determine the Objective Response Rate (ORR), which measures the proportion of patients whose tumors shrink in response to the treatment. Researchers will also evaluate how long patients live without the disease getting worse (Progression-Free Survival), overall survival, quality of life, and any side effects experienced. The study plans to enroll 30 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Biological: Adebrelimab, Drug: gemcitabine, Drug: Albumin-Bound Paclitaxel /nab-PaclitaxelParticipants in this single arm will receive Adebrelimab (1200 mg, IV, Day 1), Gemcitabine (800 mg/m^2, IV, Days 1 and 8), and albumin-bound paclitaxel (100 mg/m^2, IV, Days 1 and 8) every 3 weeks (21 days) for 6 to 8 cycles. Adebrelimab is administered first, followed by chemotherapy after an interval of at least 30 minutes. Maintenance phase: After 6-8 cycles of initial treatment, Adebrelimab will be continued for up to 2 years, while Gemcitabine and albumin-bound paclitaxel will be administered alternately every cycle. Treatment continues until disease progression/recurrence, unacceptable toxicity, withdrawal of consent, or other specified discontinuation criteria are met. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 to 75 years, male or female. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. No prior local or systemic treatment for biliary tract malignancy. Histologically or cytologically confirmed initially unresectable or inoperable biliary tract cancer; recurrent biliary tract tumor after surgery; or patients who received post-operative adjuvant therapy must have been off treatment for more than 6 months. Adequate organ and hematological function. Life expectancy of ≥ 3 months. Laboratory results within 7 days prior to the first dose meeting the following criteria:Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, Platelets ≥ 75 × 10^9/L, Hemoglobin ≥ 90 g/L (without blood transfusion or G-CSF within 2 weeks prior to screening); Serum albumin ≥ 30 g/L, Total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Serum creatinine ≤ 1.5 × ULN or Creatinine clearance > 50 mL/min; INR ≤ 1.2 or PT exceeding the normal control range by ≤ 2 seconds; Urine protein < 2+ (if ≥ 2+, 24-hour urine protein quantification must be < 1.0 g). Women of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must not be lactating. Male subjects with female partners of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug, and must not donate sperm during this period.
Key exclusion criteria (1 listed)
- Pathological diagnosis of mixed hepatocellular carcinoma or containing other non-cholangiocarcinoma malignant components. Prior systemic therapy. History of or concurrent other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid cancer. Active pulmonary tuberculosis infection within 1 year prior to enrollment; or history of active tuberculosis infection over 1 year ago without formal anti-tuberculosis treatment or with tuberculosis still in the active phase. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis. Requiring long-term systemic corticosteroid therapy (dose equivalent to > 10 mg/day prednisone) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are allowed. Severe cardiopulmonary or renal dysfunction. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); history of hypertensive crisis or hypertensive encephalopathy. HBV DNA > 2000 IU/ml, or active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection). Active infection requiring systemic therapy. Human immunodeficiency virus (HIV 1/2 antibody) positive. History of psychotropic drug abuse, alcoholism, or drug addiction. History of allergy to study drugs. Other factors that, in the judgment of the investigator, may affect the safety of the subject or compliance with the trial
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 |
|---|---|---|
| Adebrelimab1200 mg, intravenous (IV) infusion, administered on Day 1 of each 21-day cycle. | Biological | Experimental Arm |
| gemcitabine800 mg/m^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle. | Drug | Experimental Arm |
| Albumin-Bound Paclitaxel /nab-Paclitaxel100 mg/m^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle. | Drug | Experimental Arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
The proportion of patients whose tumor volume shrinks to a predefined value and maintains the minimum time requirement, defined as the sum of Complete Response (CR) and Partial Response (PR). Assessed by investigators according to RECIST 1.1 criteria.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
Overall Survival (OS)
Time frame: From the first dose of study treatment until death from any cause, assessed up to approximately 36 months.
Disease Control Rate (DCR)
Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
Duration of Response (DoR)
Time frame: From the first confirmed response until disease progression or death, assessed up to approximately 24 months.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the signing of informed consent up to 90 days after the last dose of study medication.
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 25 Jun 2026.
- 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.
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, gemcitabine and Albumin-Bound Paclitaxel /nab-Paclitaxel in people with Biliary Tract Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University 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 1 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 25 Jun 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 Yongxiang Xia, Doctor (＋8613815893869, yx_xia@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 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 25 Jun 2026.