Adebrelimab with apatinib plus gemcitabine–cisplatin for initially unresectable biliary tract cancer

A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer

This trial tests whether adding the immunotherapy adebrelimab and the targeted drug apatinib to standard chemotherapy helps people with newly diagnosed, unresectable biliary tract cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: Adebrelimab, chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07135544 on ClinicalTrials.gov

What this trial studies

This is a single-arm, multicenter phase 2 exploratory trial that gives patients with newly diagnosed, unresectable biliary tract cancer a combination of adebrelimab, apatinib, and a gemcitabine–cisplatin (GC) chemotherapy regimen. Eligible adults (18–80 years) have not received prior systemic therapy, have ECOG performance status 0–1, and meet predefined laboratory and organ function criteria. The study measures treatment activity and tolerability, recording tumor response, conversion to resectability when applicable, progression-free survival signals, and adverse events. Enrollment and treatment are conducted at participating centers including Tongji Hospital in Wuhan, Hubei.

Who should consider this trial

Good fit: Adults aged 18–80 with newly diagnosed, untreated biliary tract cancer that is judged unresectable, with ECOG 0–1 and adequate organ and blood test results, are the intended participants.

Not a fit: Patients who have received prior systemic therapy, have poor performance status (ECOG ≥2), significant organ dysfunction, active severe comorbidities, or who are pregnant or breastfeeding are unlikely to qualify or benefit from this regimen.

Why it matters

Potential benefit: If successful, the combination could increase tumor shrinkage and possibly convert some unresectable tumors to resectable disease or prolong disease control.

How similar studies have performed: Combinations of immune checkpoint inhibitors with anti‑angiogenic agents and chemotherapy have shown promising signals in biliary tract and other solid tumors, but this exact triple combination remains exploratory.

Eligibility criteria

Inclusion Criteria:

\- 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:

1. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
2. Platelet count ≥ 75 × 10\^9/L;
3. Hemoglobin ≥ 90 g/L;
4. Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN);
5. Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN;
6. Albumin ≥ 3 g/dL
7. 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.

Exclusion Criteria:

* 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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yongjun Chen Yongjun Chen

Conditions Biliary Tract Cancer; Adebrelimab