Actively Recruiting
A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer
Led by Yongjun Chen · Updated on 2025-08-22
37
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatment options for patients with biliary tract tumors that cannot be removed by surgery and have not been treated before. This exploratory study evaluates the effects and safety of a combination therapy using Adebrelimab, a monoclonal antibody, together with targeted therapy and chemotherapy. The goal is to understand how well this combined treatment works for these patients. Participants receive Adebrelimab through an intravenous infusion of 1200 mg on the first day of each 3-week cycle. Alongside this, they get Gemcitabine at 1000 mg/m2 on days 1 and 8, and Cisplatin at 50 mg/m2 on day 1, both repeated every 3 weeks. Additionally, Apatinib is taken orally at 250 mg once daily. This treatment plan continues through multiple cycles to assess effectiveness and safety. During the study, patients are monitored regularly, with assessments at the end of cycles 6 and 10, each lasting 21 days, to measure the overall response rate. Researchers also track disease control, progression-free survival, adverse events, and overall survival over periods up to 24 months. Participants undergo various evaluations including physical exams and lab tests, and their health is followed closely to understand treatment impact over time. The study is planned to continue until late 2028.
CONDITIONS
Brief Title
A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological or histological diagnosis of malignant tumor of the biliary tract
- Classified as TxNx and TxNxM1 according to the UICC/AJCC TNM staging system (9th edition, 2024), judged as newly diagnosed incurable or unsuitable for surgery
- Age between 18 and 80 years old
- Expected survival period longer than 3 months
- Both genders eligible
- ECOG performance status score of 0 or 1
- No severe complications such as hypertension, coronary heart disease, or history of mental illness; no severe allergy history; non-pregnant and non-lactating
- Organ and hematological functions meeting specific blood count and liver/kidney function requirements
- Able to understand and sign informed consent; good compliance
- Newly diagnosed patients without prior local or systemic tumor treatment, or patients with recurrence 2 years after radical resection surgery
- Use of medically approved contraception during and 1 month after study treatment; negative serum or urine HCG test within 72 hours before enrollment; non-lactating
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors or other stimulatory/co-inhibitory T-cell receptor therapies
- Use of any other investigational drugs within 4 weeks before enrollment
- Active autoimmune disease or history of autoimmune disease requiring intervention; patients with resolved childhood asthma without current intervention allowed
- Congenital or acquired immune deficiencies including HIV infection or active hepatitis B or C
- Serious infections within 4 weeks before first administration or unexplained fever over 38.5 0C during screening
- History of allogeneic organ or hematopoietic stem cell transplantation
- Uncontrolled mental disorders
- Severe and/or uncontrollable diseases affecting study participation, including unstable angina, recent myocardial infarction, symptomatic arrhythmia, heart failure, poorly controlled diabetes, or infections after biliary drainage
- Other cancers within past 5 years except non-melanoma skin cancer and carcinoma in situ
- Allergy or hypersensitivity to any study drug or monoclonal antibody
- Unable or unwilling to sign informed consent form
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles up to 10 cycles
Participants receive Adebrelimab combined with Gemcitabine, Cisplatin, and Apatinib as part of their treatment regimen.
Visits every 3 weeks for infusions and daily oral medication
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Y
Yongjun Chen Yongjun Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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