S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhong Li
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Histologic or cytologic diagnosis of cholangiocarcinoma

• Not eligible for curative surgery

• Progressed after first-line gemcitabine-based chemotherapy

• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better

• No serious or uncontrolled concomitant medical illness

• Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: > or equal to 8 mg/dL, total bilirubin: < or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method).

Exclusion Criteria:

• Uncontrolled infection or severe active comorbid disease

• Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer

• Pregnancy or lactating women