OncoMatch/Clinical Trials/NCT07433673
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Is NCT07433673 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cemiplimab for colon and rectal cancer.
Treatment: Cemiplimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
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.
Cannot have received: investigational therapy
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.
Cannot have received: immune checkpoint inhibitor
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.
Cannot have received: radiation therapy
Participants may not have had previous radiotherapy for the biliary tract tumor.
Cannot have received: surgical resection
Patients may not have had surgical resection of biliary tract cancer prior to initiation of study intervention.
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L without granulocyte colony-stimulating factor support; WBC count ≥ 2.5 x 10^9/L; Lymphocyte count ≥ 0.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L without transfusion; Hgb ≥ 9.0 g/dL
Kidney function
Creatinine within ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min using the Cockcroft-Gault formula
Liver function
AST(SGOT)/ALT(SGPT) ≤ 2.5 × 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; Liver function Child-Pugh class A or B7, if there is evidence of cirrhosis
Cardiac function
Baseline QTcF < 450 ms (males) or < 470 ms (females); No significant cardiovascular disease (such as NYHA Class II or greater cardiac disease, MI, or CVA within 12 months, seizure disorder, uncontrolled hypertension, or unstable arrhythmia or unstable angina within 3 months)
Adequate hematological and organ function (test results from within 14 days prior to initiation of study treatment): ... Liver function Child-Pugh class A or B7, if there is evidence of cirrhosis ... Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females) [excluded]; Significant cardiovascular disease [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Columbia University Irving Medical Center · New York, New York
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