Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)

Recruiting now · Phase 2

Conditions studied: Colon and Rectal Cancer

In brief

This study is being conducted to find out if treatment with gemcitabine, cisplatin, nab-paclitaxel, and cemiplimab can shrink previously inoperable tumors enough for surgery.

Key facts

Study ID

NCT07433673

Run by

Columbia University

People needed

20

Starts

2026-08-01

Expected to finish

2029-01-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of biliary tract adenocarcinoma (intra- or extra-hepatic, and gallbladder)
• Locally advanced, unresectable BTC without evidence of distant metastatic disease. Patients with surgically unresectable BTC on diagnostic abdominal CT scan or MRI are eligible to participate in the study. Unresectable, locally advanced, but non-metastatic BTC must be confirmed with the designated site radiologist and surgeon at the treating institution (Appendix 2) and must meet at least one of the following criteria:
• Tumor involvement of both hepatic lobes and/or vessels
• Vascular invasion of the portal vein or main hepatic artery
• For perihilar tumors: bilateral hepatic duct involvement up to secondary radicles
• Atrophy of one liver lobe with invasion of contralateral vessel and/or bile duct
• Extrahepatic organ tumor invasion, except contiguous involvement of the diaphragm
• Inadequate estimated liver remnant after surgery If resectability cannot be determined based on CT or MRI, an FDG-PET may be performed, and if it cannot be determined based on imaging alone, surgical exploration is permitted.
• Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of cemiplimab added to gemcitabine, cisplatin, and nab-paclitaxel in participants <18 years of age, children are excluded from this study.
• Treatment naïve; no prior systemic therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Life expectancy of greater than 3 months.
• Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 13.3 for more information regarding evaluation of measurable disease.
• Adequate hematological and organ function (test results from within 14 days prior to initiation of study treatment):
• Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\^9/L without granulocyte colony-stimulating factor support
• White blood cell (WBC) count ≥ 2.5 x 10\^9/L (2500/uL)
• Lymphocyte count ≥ 0.5 x 10\^9/L (500/uL)
• Platelet count ≥ 100 x 10\^9/L (100,000/uL) without transfusion
• Hgb ≥ 9.0 g/dL
• AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 × ULN, unless in patients with known Gilbert disease (≤ 3 × ULN), or unless elevated secondary to biliary obstruction due to malignancy amenable to decompression prior to administration of investigational therapy
• Creatinine within ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min using the Cockcroft-Gault formula
• International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN, except for those on stable anticoagulation for at least two weeks
• Liver function Child-Pugh class A or B7, if there is evidence of cirrhosis
• Criteria for known hepatitis B and C positive subjects:

You may not qualify if…

• Histologies other than adenocarcinoma such as mixed hepatocellular carcinoma/cholangiocarcinoma, adenosquamous carcinoma or mixed adenocarcinoma/neuroendocrine carcinoma; ampullary carcinomas are also excluded.
• Has initially resectable disease or distant metastasis, including distant lymph nodes.
• Resectable BTC include the following: absence of retropancreatic and paraceliac nodal metastases or distant liver metastases, absence of invasion of the portal vein or main hepatic artery, absence of extrahepatic adjacent organ invasion, absence of disseminated disease.
• Participants may not have had systemic chemotherapy, investigational therapy, or treatment with T-cell co-stimulating or immune check point blockade therapies (including anti-CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies) prior to initiation of study treatment.
• Participants receiving any other investigational agents concurrently or other anti-neoplastic agents (hormone therapy acceptable)
• Participants may not have had previous radiotherapy for the biliary tract tumor.
• Patients may not have had surgical resection of biliary tract cancer prior to initiation of study intervention.
• Participants may not have undergone major surgery or experienced significant traumatic injury within 14 days prior to initiating study treatment or be recovering from procedure-related adverse events of > Grade 1.
• An active autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
• Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:
• Rash must cover < 10% of body surface area;
• Disease is well-controlled at baseline and requires only low-potency topical corticosteroids;
• No occurrence acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
• History of (non-infectious) idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan (history of radiation pneumonitis or fibrosis in the radiation field is permitted).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab, gemcitabine, cisplatin, or nab-paclitaxel; or known allergy or sensitivity to any of the study drug excipients.
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
• Peripheral neuropathy > Grade 2.
• A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, calcineurin inhibitors, and anti-tumor necrosis factor alpha agents) within two weeks prior to initiation of study treatment, or anticipate the need for systemic immunosuppressive medication during the course of the study, except for a one-time pulse dose of systemic immunosuppressant medication are eligible for the study after approval from the Principal Investigator.
• A known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ), excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
• An active infection requiring systemic therapy.
• Active tuberculosis
• Concurrent active hepatitis B defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
• Received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study intervention.

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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