OncoMatch/Clinical Trials/NCT06548412
CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
Is NCT06548412 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Gemcitabine and Cisplatin for metastatic biliary tract cancer.
Treatment: Gemcitabine · Cisplatin · Durvalumab · CTX-009 — To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Disease stage
Metastatic disease required
unresectable advanced, metastatic, or recurrent BTC at the time of enrollment that has not been previously treated in the metastatic setting
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for metastatic disease
Exception: Patients who received prior perioperative treatment (adjuvant and neoadjuvant) are eligible.
Previous treatment of the current malignancy. Patients who received prior perioperative treatment (adjuvant and neoadjuvant) are eligible.
Lab requirements
Blood counts
absolute neutrophil count ≥1,000/mcL; platelets ≥100,000/mcL; Hemoglobin ≥ 9 g/dL; WBC ≥ 3,000/mm3
Kidney function
Calculated creatinine clearance ≥ 60mL/min (Cockcroft-Gault); Urine protein ≤ 1+ by dipstick
Liver function
total bilirubin ≤ 1.5 institutional ULN; AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN (≤5×ULN w/ hepatic metastasis); Serum albumin ≥ 3.0 g/dL; Serum amylase and lipase level ≤ 1.5 X ULN
Patients must have adequate organ and marrow function within 14 days of treatment as described below (patients must be free of G-CSF treatment within 14 days prior to the lab test)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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 qualify