OncoMatch/Clinical Trials/NCT07433673
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Is NCT07433673 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07433673 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages