OncoMatch/Clinical Trials/NCT03801083
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
Is NCT03801083 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tumor Infiltrating Lymphocytes (TIL) for biliary tract cancer.
Treatment: Tumor Infiltrating Lymphocytes (TIL) — This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer. These are low-incidence cancers carry a poor prognosis. Participants will include patients with biliary tract cancers (BTC), including cholangiocarcinoma (both intrahepatic and extrahepatic) and gallbladder cancer, who are and are physically able to tolerate non-myeloablative chemotherapy and high-dose aldesleukin.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim; WBC ≥ 3000/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin > 8.0 g/dl
Kidney function
Serum creatinine ≤ to 1.6 mg/dl
Liver function
Serum ALT/AST ≤ to 3.5 times the upper limit of normal; Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl
Cardiac function
Documented LVEF of less than or equal to 45%; testing required in patients with age > 65 years, clinically significant arrhythmias, or history of ischemic heart disease/chest pain
Hematology: Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim; WBC ≥ 3000/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin > 8.0 g/dl. Chemistry: Serum ALT/AST ≤ to 3.5 times the upper limit of normal; Serum creatinine ≤ to 1.6 mg/dl; Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. Documented LVEF of less than or equal to 45%; note: testing is required in patients with age > 65 years, clinically significant arrhythmias, or history of ischemic heart disease/chest pain.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
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