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

NCT07433673 | Recruiting Phase 2 FDA Drug

• 1 other identifier: AAAV9049
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon and Rectal Cancer

Keywords

locally advanced, unresectable biliary tract cancer; Colon and Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of conversion to resectable disease and subsequent surgical resection

  Successful conversion to resectable disease must meet all of the following criteria: * Absence of extra-regional lymph node metastases, including retropancreatic or paraceliac lymph node involvement * Absence of invasion of the portal vein or main hepatic artery * Absence of extrahepatic organ tumor invasion, except for contiguous involvement of the diaphragm * Absence of bilobar liver involvement, including bilateral bile duct involvement to the secondary radicles * If right or left hepatic lobe atrophy, absence of contralateral secondary biliary radicle involvement * Absence of disseminated metastatic disease * Adequate estimated liver remnant after surgery (This may be achieved with portal vein embolization.) * Tumor resected.

  6 months from start of study treatment

Secondary Outcomes (7)

• Rate of R0 resection

  up to 5 years

• Time to resection

  up to 5 years

• Objective Response Rate (ORR)

  up to 5 years

• Median recurrence-free survival (mRFS) from the time of resection until histologic confirmation of recurrent BTC

  up to 5 years

• Median overall survival (mOS) from the start of chemotherapy with added cemiplimab therapy until death from any cause

  up to 5 years

Study Arms (1)

Cemiplimab

EXPERIMENTAL

All study participants will receive cemiplimab in addition to chemotherapy drugs (gemcitabine, cisplatin, and nab-paclitaxel).

Drug: Cemiplimab

Interventions

Cemiplimab DRUG

intravenous 300mg

Also known as: Libtayo, cemiplimab-rwlc

Cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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).

Sponsors & Collaborators

• Columbia University: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Linda Wu, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162; cancerclinicaltrials@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 25, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)